Tri-split Face Study of Skin Resurfacing Modalities for the Treatment of Melasma
Primary Purpose
Melasma
Status
Withdrawn
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
22% TCA peel
CO2 laser
Qs-NdYag laser
Sponsored by
About this trial
This is an interventional treatment trial for Melasma
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
22% TCA peel
CO2 laser
Qs-NdYAG laser
Arm Description
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 ablative fractional laser resurfacing applied to one of the three facial areas (based on random assignment- forehead, left cheek, right cheek)
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.
Outcomes
Primary Outcome Measures
modified melasma area and severity index (mMASI) score
score calculated by measuring darkness of pigment of melasma patch area
Secondary Outcome Measures
visual analog scale (VAS) assessment by physicians
CR
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02892071
Brief Title
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
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Withdrawn
Why Stopped
Our fellow completed the program before we were able to start the study
Study Start Date
December 2020 (Anticipated)
Primary Completion Date
September 2022 (Anticipated)
Study Completion Date
September 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
SUZAN OBAGI
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Melasma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
22% TCA peel
Arm Type
Active Comparator
Arm Description
22% trichloroacetic acid medium depth chemical peel applied to one of the three facial areas (based on random assignment- forehead, left cheek, right cheek)
Arm Title
CO2 laser
Arm Type
Active Comparator
Arm Description
CO2 ablative fractional laser resurfacing applied to one of the three facial areas (based on random assignment- forehead, left cheek, right cheek)
Arm Title
Qs-NdYAG laser
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
22% TCA peel
Other Intervention Name(s)
medium depth chemical peel, TCA peel
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
CO2 laser
Other Intervention Name(s)
CO2RE laser, ablative fractional laser
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Qs-NdYag laser
Intervention Description
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.
Primary Outcome Measure Information:
Title
modified melasma area and severity index (mMASI) score
Description
score calculated by measuring darkness of pigment of melasma patch area
Time Frame
6 months
Secondary Outcome Measure Information:
Title
visual analog scale (VAS) assessment by physicians
Description
CR
Time Frame
6 months
Other Pre-specified Outcome Measures:
Title
participant satisfaction assessment
Description
Participants will score their satisfaction with improvement for each modality
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Suzan Obagi, MD
Organizational Affiliation
University of Pittsburgh Medical Center
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
25068546
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.
Results Reference
result
PubMed Identifier
20514787
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.
Results Reference
result
PubMed Identifier
24858737
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.
Results Reference
result
Learn more about this trial
Tri-split Face Study of Skin Resurfacing Modalities for the Treatment of Melasma
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