| CTRI Number |
CTRI/2021/12/038951 [Registered on: 27/12/2021] Trial Registered Prospectively |
| Last Modified On: |
13/12/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Understanding the role of the pigment producing cells in the formation of keloids |
|
Scientific Title of Study
|
Investigating dermal and epidermal cells in keloid pathogenesis |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Aayush Gupta |
| Designation |
Associate Professor |
| Affiliation |
Dr. D.Y. Patil Medical College, Hospital and Research centre |
| Address |
Derpartment of Dermatology, Dr D.Y. Patil Medical College, Pimpri
Derpartment of Dermatology, Dr D.Y. Patil Medical College, Pimpri
Pune
MAHARASHTRA
411018
India |
| Phone |
9545711211 |
| Fax |
|
| Email |
aayushggupta@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Aayush Gupta |
| Designation |
Associate Professor |
| Affiliation |
Dr. D.Y. Patil Medical College, Hospital and Research centre |
| Address |
Derpartment of Dermatology, Dr D.Y. Patil Medical College, Pimpri
Derpartment of Dermatology, Dr D.Y. Patil Medical College, Pimpri
Pune
MAHARASHTRA
411018
India |
| Phone |
9545711211 |
| Fax |
|
| Email |
aayushggupta@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Aayush Gupta |
| Designation |
Associate Professor |
| Affiliation |
Dr. D.Y. Patil Medical College, Hospital and Research centre |
| Address |
Derpartment of Dermatology, Dr D.Y. Patil Medical College, Pimpri
Department of Dermatology, Dr D.Y. Patil Medical College, Pimpri
Pune
MAHARASHTRA
411018
India |
| Phone |
9545711211 |
| Fax |
|
| Email |
aayushggupta@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr. D.Y. Patil Medical College, Hospital and Research Centre, Pune |
|
|
Primary Sponsor
|
| Name |
IADVL Indian Association of Dermatology Venereology and Leprosy |
| Address |
314-315,
3rd Floor KM Trade Tower,
H 3, Sector 14,
Kaushambi, Ghaziabad,
Uttar Pradesh. 201010 |
| Type of Sponsor |
Other [National Dermatology association] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Aayush Gupta |
Dr. D.Y. Patil Medical College, Hospital and research centre |
OPD number 8, First Floor, Department of Dermatology
Pune
MAHARASHTRA |
9545711211
aayushggupta@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee, Dr. D.Y. Patil Vidyapeeth, Pune |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L918||Other hypertrophic disorders of the skin, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Individuals diagnosed with keloid (scar spread beyond original borders and no spontaneous regression within 1 year)
Having taken no treatment for keloids before (Treatment naïve)
Not on any immunomodulator drugs for other conditions
Male and female
Above 18 years age
.
|
|
| ExclusionCriteria |
| Details |
 Mixed or unclear diagnosis
 Pregnant/lactating females
 Patients who refuse to participate in the study
 Patients having other diseases like diabetes, or with communicable diseases
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
The proposed study is an exploratory study to understand the relation between melanocytes and fibroblasts in keloids. It is not a clinical trial, and hence no success/failure is involved.
Understanding the effect of modulation of melanin content in melanocytes on the fibroblast biology |
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Understanding the effect of melanocyte-conditioned media (melanocyte secretome) on fibroblast biology (trans-well co-culture set up). |
1 year |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
03/01/2022 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
1. Guy WM, Pattisapu P, Ongkasuwan J, Brissett AE. Creation of a head and neck Keloid quality of life questionnaire. The Laryngoscope. 2015;125(12):2672-6.
2. Robles DT, Berg D. Abnormal wound healing: keloids. Clin Dermatol 2007;25:26–32.
3. Bayat A, Arscott G, Ollier WE, Ferguson MW, et al. Description of site specific morphology of keloid phenotypes in an Afrocaribbean population. Br J Plast Surg 2004;57:122–33.
4. Tan A, Glass DA. Patient-reported outcomes for keloids: a systematic review. Giornale italiano di dermatologia e venereologia: organo ufficiale, Societa italiana di dermatologia e sifilografia. 2019;154(2):148-65.
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Keloids
- benign fibroproliferative tumours that either arise spontaneously or after
injury - are characterized by hyperproliferative fibroblasts with an increased
tendency to differentiate into myofibroblasts. This deregulation of fibroblast
function causes excessive deposition of collagen in the dermis leading to a visible
raised scar which may spread beyond the borders of the initial injury. The
prevalence of keloids is significantly higher in individuals with skin of
colour; around 16 % of people in darkly pigmented populations like African
Americans and Asian Americans are known to be affected with keloids. On the
other hand, keloids rarely develop in Caucasians, albinos and individuals with vitiligo
(on the depigmented patch), all of whom have a lower pigmentation content.
Since
keratinocytes, melanocytes and fibroblasts maintain skin homeostasis by closely
interacting with each other via several autocrine and paracrine signalling
pathways, we hypothesised that either melanocytes per se and/or the
melanin content therein could influence fibroblast biology, leading to the
development or spread of keloids.
To test
the role of perturbed melanocytes - fibroblasts cross talk in keloid
pathogenesis, we propose to carry out the following objectives:
A)
Understanding Fibroblast-Melanocyte cross-talk in
keloid pathogenesis:
A.1) Understanding the effect of melanocyte-conditioned media
(melanocyte secretome) on fibroblast biology (trans-well co-culture set up)
A.2) Understanding the effect of modulation of melanin content in
melanocytes on the fibroblast biology
|