Tri-split Face Study of Skin Resurfacing Modalities for the Treatment of Melasma

Phase 1

Withdrawn

• Conditions: Melasma
• Interventions: Drug: 22% TCA peel; Device: CO2 laser; Device: Qs-NdYag laser

• Registration Number: NCT02892071
• Lead Sponsor: SUZAN OBAGI

Brief Summary

Tri-split face study of skin resurfacing modalities for the treatment of melasma, comparing the medium depth trichloroacetic acid peel, CO2 laser and Qs-NdYag laser.

Detailed Description

Melasma is an acquired chronic and relapsing hyperpigmentation disorder, with a significant negative impact on the quality of life of patients. Melasma is more common in patients with skin of color and has also been linked to chronic ultraviolet (UV) and heat exposure, family history and hormonal factors. There are several studies in the literature using various therapies for melasma, including sun protection, topical therapies, lasers and chemical peels. However, many of these studies vary greatly in their efficacies and side effect profiles, due to varying and undelineated pre and post-op procedure regimens. Side effects of post-inflammatory hyper and hypopigmentation and rebound are reported in these studies. The investigators would like to conduct a tri-split face study that compares a 22% trichloroacetic acid (TCA) deep medium peel with an ablative fractionated CO2 laser and more pigment selective Q-switched (Qs) Nd:YAG laser. To minimize possible post-procedure side effects and melasma rebound, the investigators will perform above treatments in conjunction with an optimal skincare regimen, starting 6 weeks before and continuing after the treatments. The investigators will perform the 22% TCA chemical peel, CO2 laser and Qs-Nd:YAG at 6 weeks after the start of the skincare regimen, and repeat treatments with Qs-Nd:YAG at weeks 8, 10, and 12. The investigators will assess participants using standardized photos in conjunction with UV imaging (Visia CR) at weeks 0, 6, 16, 20 and 24 (6 months), by measuring the modified melasma area and severity index (mMASI) scores and visual analog scale (VAS) scores as graded by participants as well as by blinded physicians based on photos and UV imaging.

Study Timeline

• Study First Submitted: 2016-08-23
• Study First Submitted QC: 2016-09-01
• Study First Posted: 2016-09-08
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-23
• Last Update Posted: 2020-03-25
• Study Start: 2020-12
• Primary Completion: 2022-09
• Study Completion: 2022-09

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• male or female participants
• 20 to 60 years old
• participants with melasma on forehead and both cheeks
• participants who failed topical therapy for melasma
• participants who have never tried other therapies for melasma

Exclusion Criteria

• pregnancy
• lactation
• use of oral contraceptive (OCP) within 3 months of starting the study
• hormonal therapy within 3 months of starting the study
• hormonal intrauterine device (IUD) within 3 months of starting the study
• history of poor wound healing or abnormal scarring
• history of lip or face herpes simplex virus infections
• active facial skin infection
• history of connective tissue disorders (such as lupus or scleroderma)
• history of isotretinoin therapy within 6 months of starting the study
• history of chemical peels, dermabrasion, laser therapy or intense pulse light (IPL) within 6 months before enrollment into the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
22% TCA peel	22% TCA peel	22% trichloroacetic acid medium depth chemical peel applied to one of the three facial areas (based on random assignment- forehead, left cheek, right cheek)
CO2 laser	CO2 laser	CO2 ablative fractional laser resurfacing applied to one of the three facial areas (based on random assignment- forehead, left cheek, right cheek)
Qs-NdYAG laser	Qs-NdYag laser	Long pulsed Q-switched Nd:Yag laser will be applied to one of the three facial areas (based on random assignment- forehead, left cheek, right cheek), performed at 2-week intervals for six sessions.

Primary Outcome Measures

Name	Time	Method
modified melasma area and severity index (mMASI) score	6 months	score calculated by measuring darkness of pigment of melasma patch area

Secondary Outcome Measures

Name	Time	Method
visual analog scale (VAS) assessment by physicians	6 months	CR