Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 15 of 17 for:    Recruiting, Not yet recruiting, Available Studies | Chloasma

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02892071
Recruitment Status : Not yet recruiting
First Posted : September 8, 2016
Last Update Posted : April 5, 2019
Sponsor:
Information provided by (Responsible Party):
SUZAN OBAGI, University of Pittsburgh

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.

Condition or disease Intervention/treatment Phase
Melasma Drug: 22% TCA peel Device: CO2 laser Device: Qs-NdYag laser Phase 1

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Tri-split Face Study of Skin Resurfacing Modalities for the Treatment of Melasma
Estimated Study Start Date : December 2020
Estimated Primary Completion Date : September 2022
Estimated Study Completion Date : September 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 22% TCA peel
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
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.
Other Names:
  • medium depth chemical peel
  • TCA peel

Active Comparator: CO2 laser
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
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.
Other Name: CO2RE laser, ablative fractional laser

Active Comparator: Qs-NdYAG laser
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
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 Measures :
  1. modified melasma area and severity index (mMASI) score [ Time Frame: 6 months ]
    score calculated by measuring darkness of pigment of melasma patch area


Secondary Outcome Measures :
  1. visual analog scale (VAS) assessment by physicians [ Time Frame: 6 months ]
    CR


Other Outcome Measures:
  1. participant satisfaction assessment [ Time Frame: 6 months ]
    Participants will score their satisfaction with improvement for each modality



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02892071


Contacts
Layout table for location contacts
Contact: Suzan Obagi, MD 7249407546 obagis@upmc.edu

Sponsors and Collaborators
SUZAN OBAGI
Investigators
Layout table for investigator information
Principal Investigator: Suzan Obagi, MD University of Pittsburgh Medical Center

Publications of Results:
Layout table for additonal information
Responsible Party: SUZAN OBAGI, MD, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT02892071     History of Changes
Other Study ID Numbers: PRO15090113
First Posted: September 8, 2016    Key Record Dates
Last Update Posted: April 5, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Melanosis
Hyperpigmentation
Pigmentation Disorders
Skin Diseases