A split-neck interventional study to compare the efficacy of Ablative Fractional CO2 laser vs 70% Glycolic acid peel in Acanthosis nigricans
Trial Snapshot
- Phase
- Phase 3
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 53
- Locations
- 1
- Primary Endpoint
- 1)change in texture of skin
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Coin toss, Lottery, toss of dice, shuffling cards etc
- Masking
- None
Eligibility Criteria
- Ages
- 15.00 Year(s) to 60.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •age more than 15 years 2)clinically diagnosed case of acanthosis nigricans.
Exclusion Criteria
- •patients already on treatment for acanthosis nigricans 2)patients with hypersensitivity to glycolic acid.
Outcomes
Primary Outcomes
1)change in texture of skin
Time Frame: 3 to 4 months
2)decrease in pigmentation
Time Frame: 3 to 4 months
Secondary Outcomes
- 1)Increase in efficacy of topical treatments(2)Decrease in skin thickness)
Investigators
Dinesh Kumar
Command Hospital Air Force Bangalore