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

NCT02892071 | Withdrawn Phase 1 FDA Drug FDA Device

• 1 other identifier: PRO15090113
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Melasma

Outcome Measures

Primary Outcomes (1)

• modified melasma area and severity index (mMASI) score

  score calculated by measuring darkness of pigment of melasma patch area

  6 months

Secondary Outcomes (1)

• visual analog scale (VAS) assessment by physicians

  6 months

Other Outcomes (1)

• participant satisfaction assessment

  6 months

Study Arms (3)

22% TCA peel

ACTIVE COMPARATOR

22% trichloroacetic acid medium depth chemical peel applied to one of the three facial areas (based on random assignment- forehead, left cheek, right cheek)

Drug: 22% TCA peel

CO2 laser

ACTIVE COMPARATOR

CO2 ablative fractional laser resurfacing applied to one of the three facial areas (based on random assignment- forehead, left cheek, right cheek)

Device: CO2 laser

Qs-NdYAG laser

ACTIVE COMPARATOR

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.

Device: Qs-NdYag laser

Interventions

22% TCA peel DRUG

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.

Also known as: medium depth chemical peel, TCA peel

22% TCA peel

CO2 laser DEVICE

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.

Also known as: CO2RE laser, ablative fractional laser

CO2 laser

Qs-NdYag laser DEVICE

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.

Qs-NdYAG laser

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• male or female participants
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• SUZAN OBAGI: lead

Related Publications (3)

• 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.

  PMID: 25068546 RESULT

• 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.

  PMID: 20514787 RESULT

• 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.

  PMID: 24858737 RESULT

MeSH Terms

Conditions

Melanosis

Interventions

Lasers, Gas

Condition Hierarchy (Ancestors)

Hyperpigmentation; Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Lasers; Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies

Study Officials

• Suzan Obagi, MD

  University of Pittsburgh Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: August 23, 2016
• First Posted: September 8, 2016
• Study Start: December 1, 2020
• Primary Completion: September 1, 2022
• Study Completion: September 1, 2022
• Last Updated: March 25, 2020

Record last verified: 2020-03