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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Withdrawn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
SUZAN OBAGI
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Melasma

Eligibility Criteria

20 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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

    First Posted
    August 23, 2016
    Last Updated
    March 23, 2020
    Sponsor
    SUZAN OBAGI
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    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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