COMPARATIVE STUDY OF

INTRALESIONAL CRYOTHERAPY VERSUS

MODIFIED INTRALESIONAL
RADIOFREQUENCY COMBINED WITH
INTRALESIONAL STEROID IN THE
MANAGEMENT OF KELOIDS

PLAN OF THESIS

FOR APPROVAL OF THE SUBJECT OF THE THESIS TO BE SUBMITTED

IN THE PARTIAL FULFILLMENT OF THE REQUIREMENTS

FOR THE DEGREE OF

M.D. (DEPARTMENT OF DERMATOLOGY, VENEREOLOGY AND

LEPROSY)

OF THE

BABA FARID UNIVERSITY OF HEALTH SCIENCES, FARIDKOT

2023 DR. ALKA CHAUHAN

_____________________________________________________________
DEPARTMENT OF DERMATOLOGY, VENEREOLOGY AND
LEPROSY,
GOVERNMENT MEDICAL COLLEGE, AMRITSAR
BABA FARID UNIVERSITY OF HEALTH SCIENCES, FARIDKOT
APPLICATION FORM FOR APPROVAL OF SUBJECT OF
PLAN OF THESIS FOR
M.D. (DEPARTMENT OF DERMATOLOGY, VENEREOLOGY
AND LEPROSY)
1. Name of the candidate Dr. Alka Chauhan
2. Father’s name Mr. Ranbir Singh Chauhan
3. Mother’s name Mrs. Sunita Chauhan
Address of the candidate PG Girls Hostel, H Block, Room No. 70,
4.
for correspondence GMC, Amritsar 143001
Month & year of passing
5. 2019
M.B.B.S.
Name of University from VCSGGMS&RI, Srinagar Garhwal,
6.
which graduated Uttarakhand 246149
Post-Graduate student in the Department
7. Present occupation of Dermatology, Venereology and Leprosy,
Government Medical College, Amritsar.
Experience of medical
8. NIL
work
Date of joining M.D.
9. October, 2023
Course
Likely date of appearing in
10. July 2026
the M.D. Examination
COMPARATIVE STUDY OF
INTRALESIONAL CRYOTHERAPY
VERSUS MODIFIED INTRALESIONAL
11. Proposed subject of thesis
RADIOFREQUENCY COMBINED WITH
INTRALESIONAL STEROID IN THE
MANAGEMENT OF KELOIDS
Adequate facilities are available in the
Facilities for work on the
12. Department of Skin & VD, Government
subject of thesis
Medical College, Amritsar.
Detailed scheme according
13. to which the candidate Plan Attached
proposes to work
Dr. Sandeep Sidhu,
MD., Associate Professor,
Name and address of the
Department of Dermatology,
Supervisor
14. Venereology and Leprosy
Govt. Medical College, Amritsar.
Dr. Tejinder Kaur,
MD., Professor & Head,
Name and address of the
Department of Dermatology,
15. Co-supervisors
Venereology and Leprosy
Govt. Medical College, Amritsar

Signature of the candidate ________________ Dated:_____________

ii
 CERTIFICATE OF SUPERVISORS

This is to certify that the facilities for the work on the subject of thesis titled
“COMPARATIVE STUDY OF INTRALESIONAL CRYOTHERAPY VERSUS
MODIFIED INTRALESIONAL RADIOFREQUENCY COMBINED WITH
INTRALESIONAL STEROID IN THE MANAGEMENT OF KELOIDS” allotted
to the candidate Dr. Alka Chauhan do exist in the Department of Skin & VD,
Government Medical College, Amritsar and will be provided to the candidate.
We will see that the data being included in the thesis is genuine and is
complete.

Dr. Tejinder Kaur, Dr. Sandeep Sidhu,

MD., MD.,
Professor & Head, Associate Professor,
Department of Dermatology, Department of Dermatology,
Venereology and Leprosy Venereology and Leprosy,
Govt. Medical College, Amritsar Govt. Medical College, Amritsar.
(Co-supervisor) (Supervisor)

Place: Amritsar

Dated: _____________
iii
 DEPARTMENT OF DERMATOLOGY

GOVERNMENT MEDICAL COLLEGE, AMRITSAR

This is to certify that the facilities for work on the subject of thesis titled
“COMPARATIVE STUDY OF INTRALESIONAL CRYOTHERAPY VERSUS
MODIFIED INTRALESIONAL RADIOFREQUENCY COMBINED WITH
INTRALESIONAL STEROID IN THE MANAGEMENT OF KELOIDS” do exist
in the Department of Skin & VD, Government Medical College, Amritsar and
will be provided to the candidate. The subject of thesis is connected with
Science and Practice of Medicine.

Dr. Tejinder Kaur,

MD.,
Professor and Head,
Department of Dermatology,
Venereology and Leprosy,
Government Medical College,
Amritsar.

Place: Amritsar

Dated: __________
iv
 UNDERTAKING

The topic submitted by the candidate “COMPARATIVE STUDY OF

INTRALESIONAL CRYOTHERAPY VERSUS MODIFIED INTRALESIONAL
RADIOFREQUENCY COMBINED WITH INTRALESIONAL STEROID IN
THE MANAGEMENT OF KELOIDS” for approval is a new research topic and
not already used by anyone.

Dr. Tejinder Kaur, Dr. Sandeep Sidhu,

MD., MD.,
Professor & Head, Associate Professor,
Department of Dermatology, Department of Dermatology,
Venereology and Leprosy Venereology and Leprosy,
Govt. Medical College, Amritsar Govt. Medical College, Amritsar.
(Co-supervisor) (Supervisor)

DR. ALKA CHAUHAN,

Post Graduate Student,
Department of Dermatology,
Venereology and Leprosy,
Govt. Medical College, Amritsar.

Place: Amritsar

Dated: _____________

v
 GOVERNMENT MEDICAL COLLEGE, AMRITSAR

Name of the candidate Dr. Alka Chauhan

COMPARATIVE STUDY OF
INTRALESIONAL CRYOTHERAPY
VERSUS MODIFIED INTRALESIONAL
Topic
RADIOFREQUENCY COMBINED WITH
INTRALESIONAL STEROID IN THE
MANAGEMENT OF KELOIDS
Examination M.D. (Skin & VD)
Date of enrolment October, 2023
In which Research Committee
Thesis members committee of
has the thesis been presented
Government Medical College, Amritsar
and approved
Dr. Tejinder Kaur
MD., Professor & Head,
Professor of Speciality Department of Dermatology,
Venereology and Leprosy.
Government Medical College, Amritsar.
Dr. Sandeep Sidhu
MD., Associate Professor,
Supervisor of the thesis Department of Dermatology,
Venereology and Leprosy.
Government Medical College, Amritsar.
Dr. Tejinder Kaur
MD., Professor & Head,
Co-supervisor of the thesis Department of Dermatology,
Venereology and Leprosy.
Government Medical College, Amritsar.
MEMBERS OF THE
THESIS/RESEARCH Signature with stamp
COMMITTEE
1. Head of the institute/college

2. Chairman of Thesis committee

Member thesis committee

Member thesis committee

Member thesis committee

3. Chairman ethical committee

Member ethical committee

Member ethical committee

Member ethical committee

vi
 ABSTRACT OF PLAN OF THESIS

COMPARATIVE STUDY OF INTRALESIONAL

CRYOTHERAPY VERSUS MODIFIED
Title INTRALESIONAL RADIOFREQUENCY
COMBINED WITH INTRALESIONAL STEROID
IN THE MANAGEMENT OF KELOIDS
For the degree of M.D (Skin & VD)
Name of the candidate Dr. Alka Chauhan
Dr. Sandeep Sidhu
MD., Associate Professor,
Name and address of Department of Dermatology,
the supervisor Venereology and Leprosy.
Government Medical College, Amritsar.
Dr. Tejinder Kaur
MD., Professor & Head,
Co-Supervisor Department of Dermatology,
Venereology and Leprosy.
Government Medical College, Amritsar.
Department of Dermatology,
Institution Venereology and Leprosy,
Govt. Medical College, Amritsar.

Keloids present as nodular firm lesions that extend beyond the area of injury,
frequently affecting body areas like chest, shoulders, earlobes and upper
back. Although several treatment options are available for keloid scars, none
have demonstrated widespread efficacy. Thus, the present study will be
conducted with an aim to study and compare efficacy of intralesional
cryotherapy vs modified intralesional radiofrequency combined with
intralesional steroid in management of keloids. Fifty keloid lesions will be
considered for the study, from the patients visiting the outpatient department
of Dermatology, Venereology and Leprosy, Government Medical College,
Amritsar and divided into two groups: Group A including patients undergoing
intralesional cryotherapy. And Group B including patients undergoing modified
intralesional radiofrequency combined with intralesional steroid. Details of the
history, clinical examination and relevant investigations will be carried out and
recorded in pre-structured proforma. All data will be tabulated and subjected
to appropriate statistical analysis to obtain results.

vii
 INTRODUCTION

Keloids are pathological scars presenting as nodular firm lesions that extend
beyond the area of injury. They do not spontaneously regress, often
continuing to grow over time.1 The most frequently affected body areas are
chest, shoulders, earlobes and upper back. Symptoms often include itching
and pain. Unlike hypertrophic scars, keloids do not improve over time and
commonly recur following surgical excision. Large lesions may lead to
cosmetic disfigurement and functional impairment, thus affecting the quality of
life.2,3

Both genetic and environmental factors play a role in keloid development.

Predisposed individuals may develop a keloid following any level of skin
trauma including surgery, piercings, acne, tattooing, insect bites, burns,
lacerations, abrasions, vaccinations, and any other process resulting in
cutaneous inflammation. Increased tension in a wound also may contribute to
keloid formation.4

Keloid formation is theorized to be the result of an imbalance of increased

synthesis of collagen and Extracellular matrix(ECM) and decreased
degradation of these products. Increased synthesis of ECM collagen is
thought to be related to the overactivation of keloid fibroblasts via the
overexpression of inflammatory mediators—namely, TGF-β1. Differential
production of isoforms of TGF-β is proposed to be responsible for the
excessive collagen production by fibroblasts seen in pathologic scarring. 5

Although several treatment options are available for keloid scars, none have
demonstrated widespread efficacy. Intralesional corticosteroid injection,
typically using triamcinolone acetonide, is commonly used and well tolerated,
but recurrence rates of around 50 percent are common. Other minimally
invasive options, such as silicone gel sheets, silicone occlusive dressings,
and pressure devices, offer limited efficacy in keloid treatment. 6

1
Corticosteroids were proved to induce keloid regression through many
different mechanisms. They suppress inflammation by inhibiting leukocyte and
monocyte migration and phagocytosis.

It was shown that dexamethasone induced keloid regression via interaction

with glucocorticoid receptors and suppressed endogenous VEGF expression
and fibroblast proliferation.7

The intralesional cryosurgery needle achieves destruction of keloid scars

through direct cell anoxia due to the formation of intracellular ice crystals,
which removes water from cells. In addition, the cold temperature damages
endothelial cell junctions and causes blood stasis, thereby producing
microthrombi, vascular injury, and ultimately, tissue necrosis. As liquid
nitrogen passes through the needle, a lethal zone (<22°C) is created around
the inserted probe in the dermis, thereby directly destroying the pathological
cells. Treating patients with intralesional cryosurgery transforms the scar
architecture—the collagen fibers become more aligned in a parallel
arrangement and the structure mimics normal, organized dermis. 8 Treated
keloids display a reduced number of proliferating cells, myofibroblasts, and
mast cells.1 This is in contrast to traditional contact cryosurgery, which forms a
lethal zone situated on the epidermis, often leading to unwarranted side
effects and inadequate penetration to the deeper dermis. 6

Keloidal tissue is tough and therefore injecting drugs can be difficult.

Radiofrequency (RF) energy delivered into keloidal tissue creates the channel
which makes the delivery and absorption of drugs easier. Radiofrequency
tissue volume reduction induces controlled protein denaturation in soft tissue
structures using very low levels of RF energy. After this technique, wound
healing will take its normal process with scar formation and retraction of
tissue, resulting in overall reduction of volume in the treated area. 9

In conventional intralesional radiofrequency surgery, the energy is delivered

through the tip, which dissipates in all directions and may cause damage to
the epidermis. In the modified technique, the energy is delivered through the

2
hole on the undersurface of cannula, and thus, does not damage the
epidermis.10

The present study will be conducted with an aim to study and compare
efficacy of intralesional cryotherapy vs modified intralesional radiofrequency
combined with intralesional steroid in management of keloids.

3
 REVIEW OF LITERATURE

Mustoe TA et al (2002) highlighted a primary role for silicone gel sheeting

and intralesional corticosteroids in the management of a wide variety of
abnormal scars. The authors concluded that these are the only treatments for
which sufficient evidence exists to make evidence-based recommendations.3

Robles DT et al (2007) reviewed that wound healing is a complex and

carefully regulated physiologic response to a traumatic injury. Deregulation of
this coordinated process can lead to exuberant scar formation as seen in
keloids and hypertrophic scars.2

Goldenberg G et al (2013) reviewed that keloids are benign growths

characterized by excessive collagen formation. The treatment of keloid scars
remains a challenging clinical dilemma for both patients and providers.
Intralesional cryosurgery has emerged as a safe and effective new treatment
by destroying the hypertrophic scar tissue with minimal damage to the skin
surface.6

Van Leeuwen MCE et al (2015) conducted a prospective multicenter study

on 27 patients with 29 keloid scars, using intralesional cryotherapy with
CryoShape. After 12 months, keloid volume decreased by an average of 63%
(p < 0.01), with a 24% recurrence rate. Hypopigmentation recovered in 69% of
cases within a year. The study concluded that intralesional cryotherapy is
effective in reducing keloid volume and symptoms.8

Weshay AH et al (2015) assessed the safety and efficacy of combining

radiofrequency (RF) with intralesional (IL) steroid injections for keloid
treatment in 18 patients. After 3 to 4 sessions, all patients experienced
significant reductions in keloid volume (average reduction of 95.4%),
improved pliability, height, and erythema, and decreased subjective
symptoms. No pain, infection, or bleeding were reported. The study concluded
that this combination therapy is both effective and safe, providing favorable
cosmetic results and a lower recurrence rate. 11

4
Kraeva E et al (2017) presented a case of a 39-year-old African-American
man (Fitzpatrick VI) with a 10-year history of keloid, who was successfully
treated with eight sessions of fractionated carbon dioxide (CO2) laser
immediately followed by laser-assisted drug delivery (LADD) of topical
triamcinolone acetonide (TAC) ointment. They concluded that this
combination treatment modality may be safe and efficacious for keloids in skin
of color (Fitzpatrick IV-VI) and other patients.1

Berman B et al (2017) Numerous treatments have been studied for keloid

and hypertrophic scars,which include conventional therapies such as
occlusive dressings, compression therapy, and steroids; surgical therapies
such as excision and cryosurgery; and adjuvant and emerging therapies
including radiation therapy, interferon, 5- fluorouracil, imiquimod, tacrolimus,
sirolimus, bleomycin, doxorubicin, transforming growth factor-beta, epidermal
growth factor, verapamil, retinoic acid, tamoxifen, botulinum toxin A, onion
extract, silicone-based camouflage, hydrogel scaffold, and skin tension
offloading device.5

O'Boyle CP et al (2017) reviewed about use of intralesional cryotherapy in

management of a keloid or hypertrophic scar. The findings suggested that the
technique is safe and achieves good scar reduction with very few treatments.
Adverse effects include depigmentation, recurrence and pain. Pain and
recurrence appear to be uncommon and depigmentation may be temporary. 12

Morelli Coppola M et al (2018) reviewed the use of Triamcinolone acetonide

(TAC) for treating keloid scars, noting its variable efficacy as a standalone
treatment with regression rates between 50%-100% and recurrence rates of
33% after one year and 50% after five years. TAC proved more effective but
had higher complications compared to verapamil. Combining TAC with
verapamil or 5-fluorouracil showed better and more stable outcomes with
fewer side effects.7

Aggarwal A et al (2018) compared five treatment modalities for keloids in a

study with 100 patients divided into five groups. The treatments included
intralesional triamcinolone acetonide (TAC), TAC with hyaluronidase,
5
verapamil hydrochloride, radiofrequency, and radiofrequency with TAC. The
clearance rates were 75%, 68.75%, and 75% for TAC, TAC with
hyaluronidase, and radiofrequency with TAC, respectively, whereas verapamil
and radiofrequency alone had lower efficacy. TAC with hyaluronidase showed
the least side effects, making it the safest and most effective treatment
option.13

Kaushal V et al (2020) compared the effectiveness of intralesional

triamcinolone acetonide (TAC) alone versus combined intralesional
radiofrequency (RF) and TAC in treating keloids. Fifty patients were divided
into two groups of 30. Group A received TAC, while Group B received RF
followed by TAC over six sessions with follow-ups. At 33 weeks, 73.4% of
Group A and 80% of Group B achieved significant improvement, with Group B
showing greater POSAS score declines and fewer recurrences. Both
treatments had similar side effect rates, but the combination therapy had
better long-term outcomes.9

Taneja N et al (2023) elaborated that intralesional radiofrequency using

intravenous canula (IVC) is a commonly used procedure for selective ablation
of dermal and subcutaneous lesions, while sparing the epidermis. In this
procedure, an IVC is inserted into the depth of the lesion, and energy is
delivered at the tip of the inner metallic cannula, which dissipates in all the
directions. However, it may cause damage to the surface epithelium when the
dermal pathology is close to the epidermis (eg, keloid), resulting in slow
healing, bad esthetic outcome, and risk of recurrence and scarring.10

McGinty S et al (2023) reviewed the evaluation and treatment of keloids and

the role of the interprofessional team in managing and educating patients with
this condition. Keloids result from abnormal wound healing in response to skin
trauma or inflammation. Keloid development rests on genetic and
environmental factors. Overactive fibroblasts producing high amounts of
collagen and growth factors are implicated in the pathogenesis of keloids.4

6
 AIMS AND OBJECTIVES

AIM

To compare intralesional cryotherapy vs modified intralesional radiofrequency

combined with intralesional steroid in management of keloids.

OBJECTIVES

 To study efficacy of intralesional cryotherapy in the management of

keloids.

 To study efficacy of modified intralesional radiofrequency combined

with intralesional steroid in management of keloids.

 To compare treatment outcomes of both modalities

7
 STUDY DESIGN

STUDY AREA: Department of Dermatology, Venereology

and Leprosy at Government Medical College,
Amritsar.

INCLUSION CRITERIA: EXCLUSION CRITERIA:

1. Patients with infected keloids.
1. Age group 18 - 60 years. 2. Any co-existing inflammatory skin
diseases.
2. Both sexes. 3. Pre-existing bleeding disorders
4. Patient with any artificial implant.
3. Size of keloid < 6 cm2 5. Any comorbidities, uncontrolled
diabetes mellitus/Hypertension.
6. Pregnancy
7. Lactation
8. Immunodeficient patients
9. Diseases that react adversely to
cold (Raynaud’s disease,
cryoglobulinemia, cold urticaria).
10. Unrealistic expectations or with
psychiatric illnesses.

STUDY POPULATION: Fifty keloid lesions will be considered for the study,
from the patients visiting the outpatient department of Dermatology,
Venereology and Leprosy, Government Medical College, Amritsar, after
application of inclusion and exclusion criteria..

Fifty keloid lesions will be randomly divided into two equal groups
Group A will include patients undergoing intralesional cryotherapy. Group B
will include patients undergoing modified intralesional radiofrequency
combined with intralesional steroid

All data will be tabulated and subjected to appropriate statistical analysis to

obtain results.

8
 MATERIAL AND METHODOLOGY

STUDY AREA: Department of Dermatology, Venereology and Leprosy at

Government Medical College, Amritsar.

STUDY DESIGN: Analytical comparative study.

STUDY POPULATION: Fifty keloid lesions will be considered for the study,
from the patients visiting the outpatient department of Dermatology,
Venereology and Leprosy, Government Medical College, Amritsar and
approval from institutional ethics committee, Government Medical College,
Amritsar will be taken. The patients who will fulfill inclusion criteria will be
recruited in the study after taking a written informed consent.

DIAGNOSIS: The Patient’s diagnosis will be made based on the history taken
and the clinical examination.

SAMPLING TECHNIQUE: Purposive sampling technique will be used in this

study.

SAMPLE SIZE: 50 keloid lesions

INCLUSION CRITERIA:

1. Age group 18 - 60 years.

2. Both sexes.

3. Size of keloid < 6 cm2

EXCLUSION CRITERIA:

1. Patients with infected keloids.

2. Any co-existing inflammatory skin diseases.

3. Pre-existing bleeding disorders

4. Patient with any artificial implant.

5. Any comorbidities, uncontrolled diabetes mellitus/Hypertension.

9
 6. Pregnancy

7. Lactation

8. Immunodeficient patients

9. Diseases that react adversely to cold (Raynaud’s disease,

cryoglobulinemia, cold urticaria).

10. Unrealistic expectations or with psychiatric illnesses.

Fifty keloid lesions will be randomly divided into two equal groups, which will
be administered two different treatment regimens. Before starting therapy, a
pre-informed written consent in vernacular language will be taken and
recorded. Details of the history, clinical examination which will include size,
site, number of lesions and relevant investigations like haemogram, urine
complete examination, bleeding and clotting time, fasting blood sugar, liver
and kidney function tests and viral markers will be carried out and recorded in
pre-structured performa. A consent for serial photographs will be taken and
record will be maintained at the start of therapy, subsequent visits, during the
course of treatment and at the end of the therapy.

Group A will include patients undergoing intralesional cryotherapy.

Group B will include patients undergoing modified intralesional radiofrequency

combined with intralesional steroid.

TREATMENT PROTOCOL AND FOLLOW UP:

GROUP A:

Steps:

Pre-medication- Oral analgesics will be given to the patient thirty minutes

before starting the procedure.

Skin preparation- The concerned lesion is cleaned with povidone iodine and
then draped maintaining aseptic conditions.

10
Anaesthesia- Translesional delivery of local anaesthetic with 2% lignocaine
with insulin syringe will be used.

The single use 16 G-18 G injection will be inserted longitudinally from one end
of the lesion to the other. The choice of the size and number of the needles
will depend on the size and consistency of the lesion. Care will be taken to
protect the skin at the exit point of the needle from liquid nitrogen by keeping
the bevel end of the needle facing upwards. Sterile gauzes will be placed
between the patient’s skin and protruding ends of the needle, in order to
protect these areas from unintended freezing. The needle will be connected to
the liquid nitrogen containing mini cryogun. Then the liquid nitrogen will be
passed through the needle. Freezing of the needle and the lesion will occur,
which will be maintained for 20 to 30 seconds. Then the needle will be
allowed to thaw and the process will be repeated for the second freeze-thaw
cycle. A sterile non-adherent dressing will be applied at the end of therapy.14

Postoperative management

Oral analgesia will be provided if required. Patients will be advised to do

several dressings with topical antiseptic ointment at home, as it is expected
that serous or serosanguinous discharge may be considerable in the week
after treatment. After approximately one week, discharge usually ceases and
dry necrosis becomes apparent. The wound then heals by re-epithelialisation.
Patients will receive intralesional cryotherapy at 4 weekly interval for a
maximum of 3 sessions depending on site and size of keloid.

GROUP B

Steps:

Pre-medication- Oral analgesics will be given to the patient thirty minutes

before starting the procedure.

Skin preparation- The concerned lesion is cleaned with povidone iodine and
then draped maintaining aseptic conditions.

11
Anaesthesia- Delivery of local anaesthetic with 2% lignocaine with insulin
syringe will be given.

Two components will be used – 1 ml syringe and an 18 G Intravenous

cannula (IVC) from which leur lock plug and flashback chamber will be
removed and discarded. A small window will be created at the undersurface of
plastic sheath near the tip of cannula, a second hole is created at the proximal
end of outer plastic sheath of cannula to allow the contact of radiofrequency
probe with the inner metallic cannula.

Cannula will be introduced into the bulk of keloid from one side, then the inner
metallic cannula will be slightly withdrawn so that the distal metallic tip is
insulated within the plastic sheath, preventing damage to epidermis. The
probe of RF machine will be touched upon window made in IV cannula
through which radiofrequency energy will be delivered to the tissue for 4-5
seconds, subsequently 0.5 ml of Triamcinolone acetonide per square
centimeter will be injected intralesionally upto blanching. Radiofrequency will
be used at low-medium (1-5) power in coagulation mode. After the injection,
ice packs will be placed over the lesion for 30 seconds to relieve injection site
pain.14

Procedure will repeated every 4 weeks for a total of 3 sessions in both

groups. All the patients will be evaluated for therapeutic outcome; a)
photographically, b) “Patient and Observer Scar Assessment Scale” (POSAS)
at 1,2,3, 6 months post treatment.9

The ‘Patient and Observer Scar Assessment Scale (POSAS)’ is the primary
outcome measure. It will be determined at the baseline and at 1,2,3,6 months.
POSAS is calculated by summing up all the nominal parameters. It consists of
2 parts: a Patient scale and an Observer Scale. Both scales contain six items
that are scored numerically and make up a ‘Total Score’ of the Patient and the
Observer scale. Photographs will be taken after an informed consent at the
first day of treatment and in subsequent visits till completion of treatment.
Adverse events regarding treatment in the both groups will be recorded on
every visit. In all patients improvement will be judged on the basis of
12
regression in size as well as the flattening of the lesion. The response to
treatment will be assessed on the basis of patient satisfaction, symptomatic
relief like pain & itching, photographic record and objectively that is reduction
in POSAS score at each visit. Percentage change in POSAS score from
baseline at each visit will be calculated as:

POSAS BL - POSAS F/U X 100%= % change from baseline

POSAS BL
[BL~ baseline, F/U~ follow up]

SAMPLE SIZE:
Analysis: A priori: Compute the required sample size
Input: Tail(s) = One

Effect size |ρ| = 0.45

α err prob = 0.05
Power (1-β err prob) = 0.95
Output:Noncentrality parameter δ = 3.3802858

Critical t = 1.6810707
Df = 43

Total sample size = 45

Actual power = 0.9536694
13
STATISTICAL ANALYSIS: At the end of study, the data will be collected and
the parameters will be analysed using ‘t’ test (paired for intragroup and
unpaired for intergroup comparison) for continuous data, Chi-square test and
Fischer’s Exact test for categorical data and Mann-Whitney U test and Kruskal
Wallis test for ordinal data by using IBM SPSS software V21. A p value of
<0.05 will be considered as statistically significant.

14
 REFERENCES

1. Kraeva E, Ho D, Jagdeo J. Successful treatment of keloid with

fractionated carbon dioxide (CO2) laser and laser-assisted drug
delivery for triamcinolone acetonide ointment in an African-American
man. J Drugs Dermatol. 2017;16(9):925–7.

2. Robles DT, Berg D. Abnormal wound healing: keloids. Clin

Dermatol. 2007;25(1):26–32.

3. Mustoe TA, Cooter RD, Gold MH, Hobbs FD, Ramelet AA,
Shakespeare PG, et al. International clinical recommendations on scar
management. Plast Reconstr Surg. 2002 Aug;110(2):560-71.

4. McGinty S, Siddiqui WJ. Keloid. [Updated 2023 Jul 17]. In: StatPearls
[Internet]. Treasure Island (FL): StatPearls Publishing; 2024 Jan-
. Available from: [Link]

5. Berman B, Maderal A, Raphael B. Keloids and hypertrophic Scars:

pathophysiology, classification, and treatment. Dermatol
Surg. 2017;43(Suppl 1):S3–S18.

6. Goldenberg G, Luber AJ. Use of intralesional cryosurgery as an

innovative therapy for keloid scars and a review of current treatments.
J Clin Aesthet Dermatol. 2013 Jul;6(7):23-6.

7. Morelli Coppola M, Salzillo R, Segreto F, Persichetti P. Triamcinolone

acetonide intralesional injection for the treatment of keloid scars:
patient selection and perspectives. Clin Cosmet Investig Dermatol.
2018 Jul 24;11:387-6.

8. van Leeuwen MCE, van der Wal MBA, Bulstra AJ, Galindo-Garre F,
Molier J, van Zuijlen PPM, et al. Intralesional cryotherapy for treatment
of keloid scars: a prospective study. Plast Reconstr Surg. 2015
Feb;135(2):580-9.

15
9. Kaushal V, Kumar S, Brar BK, Singh A. Comparative evaluation of
therapeutic efficacy and safety of intralesional triamcinolone acetonide
injection vs intralesional radiofrequency with intralesional triamcinolone
acetonide in treatment of keloids. Dermatol Ther. 2020
Nov;33(6):e13919.

10. Taneja N, Ahuja R, Gupta S. Modified technique of intralesional

radiofrequency with drug deposition in keloids using customized
intravenous cannulas. J Am Acad Dermatol. 2023 Aug;89(2):e89-e90.

11. Weshay AH, Hay RM, Sayed K, El Hawary MS, Nour-Edin F.

Combination of radiofrequency and intralesional steroids in the
treatment of keloids: a pilot study. Dermatologic Surgery. 2015 Jun
1;41(6):731-5.

12. O'Boyle CP, Shayan-Arani H, Hamada MW. Intralesional cryotherapy

for hypertrophic scars and keloids: a review. Scars Burn Heal. 2017
Apr 17;3:2059513117702162.

13. Aggarwal A, Ravikumar BC, Vinay KN, Raghukumar S,

Yashovardhana DP. A comparative study of various modalities in the
treatment of keloids. Int J Dermatol. 2018 Oct;57(10):1192-200.

14. Gupta S, Kumar B. Intralesional cryosurgery using lumbar puncture

and/or hypodermic needles for large, bulky, recalcitrant keloids. Int J
Dermatol. 2001 May;40(5):349-53.

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 PROFORMA

Sr. No : Name:
Date: Age/Sex:
OPD/[Link] : Address :

Chief Complaints with duration:

H/O Present illness:

H/O Past illness:

Family History:

Personal History:

Treatment history with response to treatment:

Medication History:

Occupation: Education:

Income(yearly):

GENERAL PHYSICAL EXAMINATION

Consciousness:

Orientation:

VITALS:
17
Blood pressure

Pulse rate

Respiratory rate

Temperature

CLINICAL EXAMINATION:

Pallor:

Icterus:

Clubbing:

Cyanosis:

Lymphadenopathy:

Edema:

Thyroid:

Trachea:

JVP:

SYSTEMIC EXAMINATION:

 Central nervous system:

 Cardiovascular System:

 Respiratory System:

 Abdominal Examination:

18
CLINICAL EXAMINATION OF KELOID:
 Total no. of lesions:
 Site:
 Size:
 Surface:
 Consistency:
 Pruritic/non-pruritic:
 Colour: skin coloured/pink coloured
 Discharge:
 Painful/painless:
 Raised/flat:
 Nodular/non-nodular:

MUCO-CUTANEOUS EXAMINATION:

SITES:

SIZE OF LESION:

19
FINAL DIAGNOSIS:

Investigations

Hb: TLC: DLC:

Platelet Count: BT: CT:

PTI: Urine C/E: FBS/RBS:

SGOT:

SGPT:

Blood Urea:

Serum Creatinine:

HIV-1, 2 Ab:

VDRL:

HbsAg:

HCV Ab:

Treatment Modality:

Duration of treatment:

Follow-up:

20
 INFORMED CONSENT

I S/O,D/O,W/O,G/O Residing
at exercising my free will, hereby
give my consent for myself/my patient to be included in the study titled
“COMPARATIVE STUDY OF INTRALESIONAL CRYOTHERAPY VERSUS
MODIFIED INTRALESIONAL RADIOFREQUENCY COMBINED WITH
INTRALESIONAL STEROID IN THE MANAGEMENT OF KELOIDS” I have
been informed to my satisfaction, in a manner and language that I
understand, the purpose and nature of the study, the nature of the drug
treatment, the safety of the procedure and the side effects associated with the
drugs and I agree to take part in the study as well as undergo investigations
as required. I have not been given any incentives nor am I under any pressure
for giving my consent.

I also give my consent to publish the present study in any publication/journal.

I am also aware of my right to opt out of the study at any time during the
course of the study without having to give the reasons for doing so and it
would not impact my treatment in any manners.

Patient’s/Guardian’s name:______________ Doctor’s name: ___________

Signature:_____________ Signature: ______________

Dated: Dated:

Relationship with patient:___________ Witness’s Name: _________

Signature: ______________

Dated:

21
22
23
 PATIENT INFORMATION SHEET
Title: “COMPARATIVE STUDY OF INTRALESIONAL CRYOTHERAPY
VERSUS MODIFIED INTRALESIONAL RADIOFREQUENCY COMBINED
WITH INTRALESIONAL STEROID IN THE MANAGEMENT OF KELOIDS”
Principal Investigator: Dr. Alka Chauhan
Designation: Post Graduate student, Department of Skin & VD, Government
Medical College, Amritsar.
Please read this form carefully. If you don’t understand the language or any
information in this sheet, please discuss with the study doctor.
Purpose of the study: “COMPARATIVE STUDY OF INTRALESIONAL
CRYOTHERAPY VERSUS MODIFIED INTRALESIONAL
RADIOFREQUENCY COMBINED WITH INTRALESIONAL STEROID IN THE
MANAGEMENT OF KELOIDS” Information about the study: It will be a
interventional prospective study approved by the Ethics Committee, GMC,
Amritsar
Patient’s role in the study:
1. To provide accurate information and cooperation during the study.
2. To allow your hospital medical records to be accessed for the purpose
of this study.
What are the potential benefits of participating in the study?

 The recommendations derived based on the outcome of this study have

the potential to change the way of treatment that help in further
management of such cases.
What are the potential risks due to participating in the study:

 This study does not pose any significant risk to the patient.

 Confidentiality: Personal data and medical records shall be used only

for research purpose and shall be kept confidential. Patients shall be
identified with the ID Number.

Voluntary participation: Entering a research study is voluntary. If patient

volunteers for a research study, he/she has the right to stop at any
time.
For any queries:

Contact:
Dr. Alka Chauhan
Department of Dermatology, Venereology and Leprosy
Government Medical College,
Amritsar, Punjab.
PH: 9897217080

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