| CTRI Number |
CTRI/2021/07/035095 [Registered on: 23/07/2021] Trial Registered Prospectively |
| Last Modified On: |
21/07/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A comparative study about chemical peel in acne |
|
Scientific Title of Study
|
A RANDOMIZED control trial to compare the efficacy and safety of 40% mandelic acid peel with 30% salicylic acid peel in Acne vulgaris |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SHEA SHARMA B |
| Designation |
JUNIOR RESIDENT/ POST GRADUATE |
| Affiliation |
CHETTINAD ACADEMY OF RESEARCH AND EDUCATION |
| Address |
Room number 8, department of dermatology , A block ,Chettinad academy of research and institute, Rajiv Gandhi Salai , Kelambakkam, Chengalpattu
Kancheepuram
TAMIL NADU
603103
India |
| Phone |
7338932929 |
| Fax |
|
| Email |
sheabsharma@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
G SRINIVASAN |
| Designation |
PROFESSOR |
| Affiliation |
CHETTINAD ACADEMY OF RESEARCH AND EDUCATION |
| Address |
Room no 8 , Department of dermatology , A block ,Chettinad academy of research and institute, Rajiv Gandhi Salai , Kelambakkam, Chengalpattu
Kancheepuram
TAMIL NADU
603103
India |
| Phone |
9443837085 |
| Fax |
|
| Email |
sriniraj07@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
SHEA SHARMA B |
| Designation |
JUNIOR RESIDENT/ POST GRADUATE |
| Affiliation |
CHETTINAD ACADEMY OF RESEARCH AND EDUCATION |
| Address |
Room no 8, department of dermatology, A block,Chettinad academy of research and institute, Rajiv Gandhi Salai , Kelambakkam, Chengalpattu
Kancheepuram
TAMIL NADU
603103
India |
| Phone |
7338932929 |
| Fax |
|
| Email |
sheabsharma@gmail.com |
|
|
Source of Monetary or Material Support
|
| CHETTINAD ACADEMY OF RESEARCH AND EDUCATION |
| SHEA SHARMA B |
|
|
Primary Sponsor
|
| Name |
SHEA SHARMA B |
| Address |
Chettinad academy of research and education, Rajiv Gandhi salai , OMR,Kelambakkam , Chennai -603103 |
| Type of Sponsor |
Other [self ] |
|
|
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 |
| SHEA SHARMA B |
CHETTINAD HOSPITAL AND RESEARCH INSTITUTE |
Room number 8 , department of dermatology, A block ,Chettinad health city, rajiv gandhi salai,kelambakkam
Kancheepuram
TAMIL NADU |
7338932929
sheabsharma@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL HUMAN ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
ACNE VULGARIS |
| Patients |
(1) ICD-10 Condition: L700||Acne vulgaris, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
MANDELIC ACID |
40% MANDELIC ACID PEEL IS APPLIED TOPICALLY AND WASHED OFF AFTER 2 Mins AT EVERY 2 WEEK INTERVAL FOR 4 to 5 sittings |
| Comparator Agent |
SALICYLIC ACID |
30% SALICYLIC ACID PEEL IS APPLIED TOPICALLY AND WASHED OFF AFTER FROSTING IS SEEN FOR EVERY 2 WEEK ONCE FOR 4 to 5 Sittings |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
PATIENTS OLDER THAN 18 YEARS OF AGE
PATIENT CONSENT FOR STUDY AND FOLLOW UP
PATIENT WILLING FOR CHEMICAL PEEL |
|
| ExclusionCriteria |
| Details |
AGE LESS THAN 18 YEARS
PATIENTS NOT WILLING FOR STUDY AND CHEMICAL PEELING PROCEDURE
PATIENTS WHO ARE PREGNANT OR BREASTFEEDING
PATIENTS WITH HYPERSENSITIVITY TO FORMUKATIONS USED
PATIENTS ON ORAL ISOTRETINOIN
PATIENTS WITH IRREGULAR MENSTRUAL CYCLE
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| REDUCTION IN NUMBER OF OLD ACNE LESIONS |
Baseline,4 weeks and10 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| REDUCTION IN NEW ACNE LESIONS |
4 and 8 weeks |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
28/07/2021 |
| 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="0"
Months="8"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
ACNE IS VERY COMMON PROBLEM ENCOUNTERED IN DERMATOLOGY OPD AND IT IS COSMETICALLY DISFIGURING. THOUGH CHEMICAL PEEL IS COMMON TREATMENT OPTION FOR ACNE VULGARIS , 40% MANDELIC ACID BEING A NEWLY EMERGING PEEL HAS NOT BEEN STUDIED MUCH . |