| CTRI Number |
CTRI/2019/01/017285 [Registered on: 28/01/2019] Trial Registered Prospectively |
| Last Modified On: |
19/01/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Efficacy,tolerability and side effects of 35% Trichloroacetic acid and 50% Glycolic acid peel in Acanthosis nigricans. |
|
Scientific Title of Study
|
Efficacy,Tolerability And Side effects of 35% Trichloroacetic acid and 50% Glycolic acid peel in Acanthosis nigricans-Single Blinded Randamonized Control Trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrJhanaranjane M |
| Designation |
Postgraduate in dermatology |
| Affiliation |
aarupadai medical college and research institute |
| Address |
department of dermatology,aarupadai medical college and research institue,kirumambakkam
Pondicherry
PONDICHERRY
607402
India |
| Phone |
9790981177 |
| Fax |
|
| Email |
jhanaranjane@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrPOudeacoumar |
| Designation |
HOD of DVL |
| Affiliation |
aarupadai medical college and research institute |
| Address |
dept of dermatology,aarupadai medical college and research institue,kirumambakkam
Pondicherry
PONDICHERRY
607402
India |
| Phone |
9443534341 |
| Fax |
|
| Email |
oudeacoumar.paquirissamy@avmc.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
DrJhanaranjane M |
| Designation |
Postgraduate in dermatology |
| Affiliation |
aarupadai medical college and research institute |
| Address |
dept of dermatology,aarupadai medical college and research institue,kirumambakkam
Pondicherry
PONDICHERRY
607402
India |
| Phone |
9790981177 |
| Fax |
|
| Email |
jhanaranjane@gmail.com |
|
|
Source of Monetary or Material Support
|
| 1.Self funding
2.Aarupadai medical college and hospital funding |
|
|
Primary Sponsor
|
| Name |
Jhanaranjane m |
| Address |
dept of dermatology, aarupadai medical college and hospital,kirumambakkam,pondicherry,607402 |
| Type of Sponsor |
Other [Self funding] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| aarupadai medical college and hospital |
aarupadai medical college and hospital,kirumambakkam,
pondicherry,607402 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| jhanaranjane m |
aarupadai medical college and hospital |
Department of dermatology
Pondicherry
PONDICHERRY |
9790981177
jhanaranjane@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional human ethical committee |
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 |
35% Trichloroacetic acid
50% Glycolic acid |
1-2ml depending upon the area of involvement
Topical application
1-2minutes contact duration
Frequency one time application for 4-5 sittings in 3weeks gap. |
| Comparator Agent |
Jayaseelan |
Statistical analyst |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients with Acanthosis nigricans between 18 to 25years giving consent for procedure.
2.Both gender are included
|
|
| ExclusionCriteria |
| Details |
1.pregnant female
2.patients with recurrent herpes infection,hypertrophic scars,keloid,active dermatitis
3.patients not willing for study.
4.patient less than 18years and more than 55years. |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To asses the clinical outcome of 35% Trichloroacetic acid and 50% Glycolic acid peel in Acanthosis nigricans. |
Clinical outcome assesed after 5 sittings of application |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To asses the tolerability and side effects of 35% Trichloroacetic acid and 50% Glycolic acid peel in Acanthosis nigricans |
Tolerability and side effects assesed every session of topical application. |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
30/01/2019 |
| 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="11"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Efficacy,tolerability and side effects of 35% Trichloroacetic acid and 50% Glycolic acid peel in Acanthosis nigricans |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
1.Acanthosis nigricans is characterized by thickened skin with a velvety texture distributed over neck,axilla,antecubital and popliteal fossae, groin folds, histopathologically characterized by papillomatosis and hyperkeratosis of skin. 2.TCA and glycolic acid peel has the property of exfoliation causing destruction of epidermis with subsequent repair and rejuvenation. 3.They also have anti-inflammatory,keratolytic and antioxidant effects that enhance rejuvenation of the skin.
|