| CTRI Number |
CTRI/2021/02/030952 [Registered on: 03/02/2021] Trial Registered Prospectively |
| Last Modified On: |
02/02/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Topical chemical peel] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Study to compare the effectiveness of 15% trichloroacetic acid peel and 35% glycolic acid peel in the treatment of acanthosis nigricans |
|
Scientific Title of Study
|
Efficacy of 15% trichloroacetic acid peel versus 35% glycolic acid peel in acanthosis nigricans - a randomized open label study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Bharati |
| Designation |
First Year Post Graduate Resident Department of Dermatology and STD |
| Affiliation |
Lady Hardinge Medical College |
| Address |
Duty Doctor Room Dermatology Ward, Department of Dermatology and STD, Lady Hardinge Medical College Shaheed Bhagat Singh Marg, Delhi
Duty Doctor Room Dermatology Ward, Department of Dermatology and STD,Lady Hardinge Medical College Shaheed Bhagat Singh Marg, Delhi
Central
DELHI
110001
India |
| Phone |
9953493348 |
| Fax |
|
| Email |
bharati2002@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Rashmi Sarkar |
| Designation |
Professor Department of Dermatology and STD |
| Affiliation |
Lady Hardinge Medical College |
| Address |
Library, First Floor Old Building Lady Hardinge Medical College Shaheed Bhagat Singh, Delhi
Library, First Floor Old Building Lady Hardinge Medical College Shaheed Bhagat Singh, Delhi
Central
DELHI
110001
India |
| Phone |
9818244340 |
| Fax |
|
| Email |
rashmisarkar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Rashmi Sarkar |
| Designation |
Professor Department of Dermatology and STD |
| Affiliation |
Lady Hardinge Medical College |
| Address |
Library, First Floor Old Building Lady Hardinge Medical College Shaheed Bhagat Singh Marg, Delhi
Library, First Floor Old Building Lady Hardinge Medical College Shaheed Bhagat Singh Marg, Delhi
Central
DELHI
110001
India |
| Phone |
9818244340 |
| Fax |
|
| Email |
rashmisarkar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Lady Hardinge Medical College, Shaheed Bhagat Singh Marg, New Delhi |
|
|
Primary Sponsor
|
| Name |
Lady Hardinge Medical College |
| Address |
Lady Hardinge Medical College Shaheed Bhagat Singh Marg, Delhi - 110001 |
| Type of Sponsor |
Government medical college |
|
|
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 |
| Bharati |
Lady Hardinge Medical College |
Room Number 6B, Out Patient Department, Department of Dermatology and STD, Smt Sucheta Kriplani Hospital, Lady Hardinge Medical College Shaheed Bhagat Singh Marg, New Delhi
Central
DELHI |
9953493348
bharati2002@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Lady Hardinge Medical College and Associated Hospitals, Shahid Bhagat Singh Marg, New Delhi 110001, India |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L83||Acanthosis nigricans, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Chemical Peel |
15% Trichloroacetic Acid Peel will be used in group A. Peel is topically applied. 3 setting of peeling will be done at the interval of 2 weeks |
| Intervention |
Chemical Peel |
35% Glycolic Acid Peel will be given in group B. Peel is topically applied. 3 settings of peeling will be done at the interval of 2 weeks |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
All adult population in the age group of 18 years and above with clinical diagnosis of acanthosis nigricans involving face or neck or elbow or any combination of these three presenting to dermatology outpatient department at Smt Sucheta Kriplani Hospital |
|
| ExclusionCriteria |
| Details |
∙ Pregnant and lactating females.
∙ Hypersensitivity to peeling agent.
∙ Skin infection at the site of acanthosis nigricans ( Herpes, pyoderma, folliculitis) ∙ Individual prone to keloid formation
∙ History of any topical application in last 4 weeks
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| ∙ Proportion of patients with Physician Assessment Score (PAS) more than 2 in the two groups. ∙ Improvement in mean ANASI Score in two groups. |
At baseline, 2, 4, 6, 8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| ∙ Mean Patient Satisfaction Score after 3 sessions in the two groups. |
4,6,8 weeks |
| ∙ Proportion of patients experiencing adverse effects in two groups. |
4, 6, 8 weeks |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
05/02/2021 |
| 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="5"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Results will be published in a scientific journal |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Acanthosis nigricans is the disorder in which the skin becomes darkened, thickened and velvety in textured. It is quite distressful for the patient. Very few studies are available which have documented the efficacy of various treatment options for the same. Therefore the aim of the study is to observe the efficacy of the treatment options routinely offered to the patient with acanthosis nigricans. There will be two group of patients, one will receive 15% trichloroacetic acid peel and other will receive 35% glycolic acid peel. Patients will be randomly allocated in one of the group. 3 sessions of peeling will be performed at an interval of 2 weeks. Following observations will be made. 1. Proportion of patients with Physician Assessment Score more than 2 in the two groups. 2. Improvement in mean ANASI score in two groups. 3. Mean Patient Satisfaction Score after 3 session in the two groups. 4. Proportion of patients experiencing adverse effects in two groups.
Data will be analyzed using freely available analytical software. |