| CTRI Number |
CTRI/2023/07/055355 [Registered on: 19/07/2023] Trial Registered Prospectively |
| Last Modified On: |
19/07/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
TO COMPARE 15% TRICHLOROACETIC ACID PEEL WITH TOPICAL 0.05% TRETINOIN CREAM IN THE TREATMENT OF ACANTHOSIS NIGRICANS |
|
Scientific Title of Study
|
TO COMPARE THE EFFICACY AND SAFETY OF 15% TRICHLOROACETIC ACID PEEL WITH TOPICAL 0.05% TRETINOIN CREAM IN THE TREATMENT OF ACANTHOSIS NIGRICANS |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr. V .SIVASUBRAMANIAN |
| Designation |
PROFESSOR AND HOD |
| Affiliation |
VINAYAKA MISSIONS MEDICAL COLLEGE,KARAIKAL |
| Address |
DEPARTMENT OF DERMATOLOGY,VENEROLOGY AND LEPROSY VINAYAKA MISSIONS MEDICAL COLLEGE KARAIKAL
Karaikal
PONDICHERRY
609609
India |
| Phone |
9884835199 |
| Fax |
|
| Email |
hoddvdvmmckkl@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. V .SIVASUBRAMANIAN |
| Designation |
PROFESSOR AND HOD |
| Affiliation |
VINAYAKA MISSIONS MEDICAL COLLEGE,KARAIKAL |
| Address |
DEPARTMENT OF DERMATOLOGY,VENEROLOGY AND LEPROSY VINAYAKA MISSIONS MEDICAL COLLEGE KARAIKAL
Karaikal
PONDICHERRY
609609
India |
| Phone |
9884835199 |
| Fax |
|
| Email |
hoddvdvmmckkl@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
NITHU SEBY |
| Designation |
POST GRADUATE |
| Affiliation |
VINAYAKA MISSIONS MEDICAL COLLEGE,KARAIKAL |
| Address |
DEPARTMENT OF DERMATOLOGY,VENEROLOGY AND LEPROSY VINAYAKA MISSIONS MEDICAL COLLEGE KARAIKAL
Karaikal
PONDICHERRY
609609
India |
| Phone |
9562749898 |
| Fax |
|
| Email |
nithuseby96@gmail.com |
|
|
Source of Monetary or Material Support
|
| DEPARTMENT OF DERMATOLOGY ,VENEROLOGY AND LEPROSY VINAYAKA MISSIONS MEDICAL COLLEGE KARAIKAL |
|
|
Primary Sponsor
|
| Name |
DEPARTMENT OF DERMATOLOGY |
| Address |
DEPARTMENT OF DERMATOLOGY,VENEROLOGY AND LEPROSY VINAYAKA MISSIONS MEDICAL COLLEGE KARAIKAL
|
| Type of Sponsor |
Private 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 |
| NITHU SEBY |
VINAYAKA MISSIONS MEDICAL COLLEGE |
DEPARTMENT OF DERMATOLOGY ,VENEROLOGY AND LEPROSY DEPARTMENT VINAYAKA MISSIONS MEDICAL COLLEGE
Karaikal
PONDICHERRY |
9562749898
nithuseby96@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHIC COMMITEE,VINAYAKA MISSIONS MEDICAL COLLEGE KARAIKAL |
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 |
15% TRICHLOROACETIC ACID |
Patients with acanthosis nigricans treated with 15% TCA every fort night for 2 months |
| Comparator Agent |
Topical 0.05% Tretinoin cream |
Patients with acanthosis nigricans treated with 0.05% tretinoin cream every night for 2 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients with acanthosis nigricans
willing to participate in study |
|
| ExclusionCriteria |
| Details |
Patients below 18 years and more than 60 years
Pregnant and lactating mothers
Patients not willing for the study
Patients allergic to TCA and Tretinoin
Patients planning for pregnancy.
|
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The degree of improvement will be assessed using grading system i.e., 0-25% - minimal improvement, 26-50% - moderate improvement, 51-75% - good improvement, 75% - excellent improvement. |
monthly for 1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| side effects |
monthly for 1 year |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
28/07/2023 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Every
consecutive patients with acanthosis nigricans will be assigned to Group A for topical
0.05% tretinoin
therapy and group B for
15% TCA
peel
The
patients in group A were advised to apply topical 0.05
% tretinoin every
night as thin film to lesions of acanthosis nigricans in the neck for 2
months In
Group B 15% TCA peel will
be done
every fortnight for 2
months after skin
sensitivity test
(over
the post auricular area) few minutes before procedure Regular sunscreen
advised
to both groups in the daytime
Patients
will be assessed
every
month for
the improvement and side effects using serial photographs |