| CTRI Number |
CTRI/2024/05/066976 [Registered on: 08/05/2024] Trial Registered Prospectively |
| Last Modified On: |
06/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Radiation Therapy |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
"Comparing laser and chemical treatments for neck dark spots" |
|
Scientific Title of Study
|
A split-neck interventional study to compare the efficacy of Ablative Fractional CO2 laser vs 70% Glycolic acid peel in 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 |
Dinesh Kumar |
| Designation |
Resident, Dermatology |
| Affiliation |
Command Hospital Air Force Bangalore |
| Address |
Room No.07
Department of Dermatology
Command Hospital Air Force Bangalore
Bangalore
KARNATAKA
560007
India |
| Phone |
8807979531 |
| Fax |
|
| Email |
dheenumbbs@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Debdeep Mitra |
| Designation |
Professor, Dermatology |
| Affiliation |
Command Hospital Air Force Bangalore |
| Address |
Room No.02
Department of Dermatology
Command Hospital Air Force Bangalore
Bangalore
KARNATAKA
560007
India |
| Phone |
8811851830 |
| Fax |
|
| Email |
debdeep5000@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dinesh Kumar |
| Designation |
Resident, Dermatology |
| Affiliation |
Command Hospital Air Force Bangalore |
| Address |
Room number 07
Department of Dermatology,
Command Hospital Air Force Bangalore
Bangalore
KARNATAKA
560007
India |
| Phone |
8807979531 |
| Fax |
|
| Email |
dheenumbbs@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of dermatology, Command Hospital Air Force, Bangalore-560007 |
|
|
Primary Sponsor
|
| Name |
Command Hospital Air Force, Bangalore |
| Address |
Department of dermatology, Command Hospital Air Force, Cambridge road, Bangalore-560007 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Dinesh kumar |
Command Hospital |
Room number 07, Department of Dermatology
Bangalore
KARNATAKA |
8807979531
dheenumbbs@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Command Hospital Air Force Bangalore |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: E00-E89||Endocrine, nutritional and metabolic diseases, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
70% Glycolic acid peel |
Total study duration: 18 months.
One side of neck will be treated with 70% glycolic acid peel .First coat of the peeling will be applied and the frosting is expected; if no frosting formed, a second coat will be applied. Sodium bicarbonate application follows to neutralize the peeling effect, and emollient will be advised for patient for 1 week after peeling .Each patient will have three sessions of glycolic acid peel with 2-weeks interval.
|
| Intervention |
Ablative Fractional CO2 laser |
Total duration 18months.
One side of neck will be treated with ablative fractional CO2 laser.
Each patient will have three sessions of fractional CO2 laser, with 2-weeks interval. The parameters will be atleast of low power (10 J), low density (500 μm), short dwell time (500 μs), and double stacking with a single pass on the affected area. |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1)age more than 15 years
2)clinically diagnosed case of acanthosis nigricans |
|
| ExclusionCriteria |
| Details |
1)patients already on treatment for acanthosis nigricans
2)patients with hypersensitivity to glycolic acid |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1)change in texture of skin
2)decrease in pigmentation |
3 to 4 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1)Increase in efficacy of topical treatments
2)Decrease in skin thickness |
6 to 7 months |
|
|
Target Sample Size
|
Total Sample Size="53"
Sample Size from India="53"
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 |
|
Date of First Enrollment (India)
|
17/05/2024 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
A split-neck interventional study to compare the efficacy of ablative fractional laser vs 70% glycolic acid peel in acanthosis nigricans is to be conducted in patients attending dermatology OPD in Command Hospital Air Force bangalore. Aesthetic concerns become valid when acanthosis nigricans affects the visible areas. Treating it early prevents worsening of the condition.Randomisation will be done by tossing a coin and following procedure will be done : Acanthosis nigricans on one side of neck will be treated with glycolic acid peel. First coat of the peeling will be applied and the frosting is expected; if no frosting formed, a second coat will be applied. Sodium bicarbonate application follows to neutralize the peeling effect, and emollient will be advised for patient for 1 week after peeling. Each patient will have three sessions of glycolic acid peel with 2-weeks interval. Other side of neck will be treated with ablative fractional CO2 laser. Each patient will have three sessions of fractional CO2 laser , with 2-weeks interval. The parameters will be atleast of low power (10 J), low density (500 μm), short dwell time (500 μs), and double stacking with a single pass on the affected area. Test area will be performed first to detect side effects to treatment. Post-operatively, ice packs for cooling will be immediately applied after laser sessions,and the patients will be advised to apply a topical antibiotic with steroid ointment and emollient after the session |