| CTRI Number |
CTRI/2024/03/064291 [Registered on: 18/03/2024] Trial Registered Prospectively |
| Last Modified On: |
26/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Procedure with fractional co2 laser and chemical peels] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A CLINICAL TRIAL TO STUDY AND COMPARE THE EFFECTS OF LASER AND FERULIC ACID CHEMICAL PEEL IN THE OF TREATMENT OF A SKIN DISEASE CALLED ACANTHOSIS NIGRICANS WHICH IS CHARACTERIZED BY DIRTY HYPERPIGMENTATION OF NECK . |
|
Scientific Title of Study
|
A COMPARATIVE STUDY OF FRACTIONAL CO2 LASER VERSUS FERULIC ACID SEQUENTIAL (12% & 8%) PEEL IN THE TREATMENT OF NECK 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 Akshata Yadav S |
| Designation |
Junior Resident |
| Affiliation |
Sri Devaraj Urs Academy Higher Education and Research |
| Address |
Room 26,Depart of Dermatology.
Sri Devaraj Urs Medical College
Tamaka, Kolar, Karnataka.
Kolar
KARNATAKA
563103
India |
| Phone |
9483145396 |
| Fax |
|
| Email |
akshatayadav453@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajashekar T S |
| Designation |
HOD |
| Affiliation |
Sri Devaraj Urs Academy Higher Education and Research |
| Address |
Room 26 .Department of Dermatology .Sri Devaraj Urs Medical College.
Tamaka, Kolar.
Kolar
KARNATAKA
563103
India |
| Phone |
9632962335 |
| Fax |
|
| Email |
abhishekhv03@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Akshata Yadav S |
| Designation |
Junior Resident |
| Affiliation |
Sri Devaraj Urs Academy Higher Education and Research |
| Address |
Room 26 .Department Of Dermatology. Sri Devaraj Urs Medical College.
Tamaka ,Kolar, Karnataka.
Kolar
KARNATAKA
563103
India |
| Phone |
9483145396 |
| Fax |
|
| Email |
akshatayadav453@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr Akshata Yadav S. Post Graduate .Department Dermatology. R L Jalappa Hospital ,Tamaka , kolar. |
|
|
Primary Sponsor
|
| Name |
Dr Akshata Yadav S |
| Address |
Room 26.Department Of Dermatology ,Venereology and Leprosy. R L Jalappa Hospital. Tamaka ,Kolar.
|
| 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 |
| Dr Akshata Yadav S |
R L Jalappa Hospital. Sri Devaraj Urs Medical College |
Department Of Dermatology.
Sri Devaraj Urs Medical College.
Kolar
KARNATAKA |
9483145396
akshatayadav453@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sri Devaraj Urs Medical College Institutinal Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: PCS||, (2) ICD-10 Condition: L83||Acanthosis nigricans, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Ferulic acid sequential peel 12% and 8% |
For 4 sittings at 2 weeks intervals. |
| Intervention |
Fractional co2 laser vs Ferulic acid sequential peel 12% and 8% |
Fractional co2 laser for 4 sittings at 2 weeks interval
Ferulic acid sequential peel 12% and 8% for 4 sittings at 2 weeks interval |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients of both the sexes with neck acanthosis nigricans
|
|
| ExclusionCriteria |
| Details |
1.Patients with recent history of any topical treatment and any procedures for neck acanthosis nigricans at least 1month before enrolment into the study.
2.Patients who received systemic retinoids six months prior to the start of study.
3.Patients with skin infection of the neck at the time of the session.
4.Patients with keloidal tendency.
5.Pregnant or lactating women.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate the efficacy of fractional co2 laser and ferulic acid sequential peel (12% and 8%) in the treatment of neck acanthosis nigricans.
It is assessed by ANASI score system.
visual analogue scale (scoring from 0 to 10)
|
Baseline, 2 weeks once follow up for 2months.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To document the post procedural side effects of fractional co2 laser & ferulic acid sequential peel (12% & 8%) in the treatment of neck acanthosis nigricans.
The Global Photograph Assessment (GPA)scale.
The visual discomfort scale (scoring from 0 to 10) |
Baseline ,once in 2weeks follow up for 2months. |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
30/03/2024 |
| Date of Study Completion (India) |
30/11/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
30/11/2024 |
|
Estimated Duration of Trial
|
Years="1"
Months="5"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
Modification(s)
|
This study is to determine the efficacy of fractional CO2 laser versus and and ferulic acid sequential peel (12% and 8%) in the treatment of neck acanthosis nigricans. As of now, no study has been done to compare these two groups. Thus making this study a first of its kind. |