Clinical trial NCT02892071: Tri-split Face Study of Skin Resurfacing Modalities for the Treatment of Melasma
Official title: Tri-split Face Study of Skin Resurfacing Modalities for the Treatment of Melasma
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Melasma
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2016-09-08
Enrollment: 0
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: modified melasma area and severity index (mMASI) score
timeFrame: 6 months
Secondary outcomes:
measure: visual analog scale (VAS) assessment by physicians
timeFrame: 6 months
Other outcomes:
measure: participant satisfaction assessment
timeFrame: 6 months
Locations:
Study officials:
affiliation: University of Pittsburgh Medical Center
name: Suzan Obagi, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Moubasher AE, Youssef EM, Abou-Taleb DA. Q-switched Nd: YAG laser versus trichloroacetic acid peeling in the treatment of melasma among Egyptian patients. Dermatol Surg. 2014 Aug;40(8):874-82. doi: 10.1097/DSS.0000000000000065.
citation: Trelles MA, Velez M, Gold MH. The treatment of melasma with topical creams alone, CO2 fractional ablative resurfacing alone, or a combination of the two: a comparative study. J Drugs Dermatol. 2010 Apr;9(4):315-22.
citation: Jalaly NY, Valizadeh N, Barikbin B, Yousefi M. Low-power fractional CO(2) laser versus low-fluence Q-switch 1,064 nm Nd:YAG laser for treatment of melasma: a randomized, controlled, split-face study. Am J Clin Dermatol. 2014 Aug;15(4):357-63. doi: 10.1007/s40257-014-0080-x.