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

Melasma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02892071
• Other study ID #: PRO15090113
• Status: Withdrawn
• Phase: Phase 1
• Start date: December 2020
• Est. completion date: September 2022

Study information

• Verified date: March 2020
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 2022
• Est. primary completion date: September 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Melanosis
• Melasma

Intervention

Drug:
• 22% TCA peel
One of the three facial areas (based on random assignment- forehead, left cheek, right cheek) will be treated with one treatment with a 22% TCA Blue Peel, to achieve a level 2 frost (medium depth peel). Each treatment will take about 20 minutes. A 22% TCA concentration will be created by combining 5.5 mL of 30% TCA (from a purchased commercial bottle) with 2mL of blue dye (commercial), immediately before application.

Device:
• CO2 laser
One of the three facial areas (based on random assignment- forehead, left cheek, right cheek) will receive one treatment with one pass of the fractionated ablative 10,600 nm CO2 (CO2RE Laser, Syneron) at Core 70 mJ, Ring 50mJ, 40% coverage, 1 pass, 8 mm square pattern. Each treatment will take about 20 minutes.
• Qs-NdYag laser
Long pulsed Q-switched Nd:Yag laser. One of the three facial areas (based on random assignment- forehead, left cheek, right cheek) will be treated with Q-switched (Qs) 1064 Nd:YAG (Medlite C3; 6 mm spot size, collimated homogenous flat- top beam profile, energy fluence 2.0 J/cm2, 5Hz), with 5% coverage and 2 passes (or until mild erythema detected). Treatments will be performed at 2-week intervals for six sessions. Each treatment will take about 20 minutes.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
SUZAN OBAGI

References & Publications (3)

Jalaly NY, Valizadeh N, Barikbin B, Yousefi M. Low-power fractional CO2 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/s — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	participant satisfaction assessment	Participants will score their satisfaction with improvement for each modality	6 months
Primary	modified melasma area and severity index (mMASI) score	score calculated by measuring darkness of pigment of melasma patch area	6 months
Secondary	visual analog scale (VAS) assessment by physicians	CR	6 months