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Combination Topical Cysteamine and Fractional 1927nm Low-Powered Diode Laser for Treatment of Facial Melasma

NCT05656833 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2022-12-19

No results posted yet for this study

Summary

The primary objective of our study is to determine the efficacy of combined topical cysteamine cream with a 1927 diode non-ablative laser (Clear + Brilliant Permea®; Solta Medical, Inc.), compared to topical cysteamine (Cyspera) alone in the treatment of melasma.

The main questions it aims to answer are

* If melasma treatment with topical cysteamine cream is more effective when used with the Clear \& Brilliant® Permea laser
* The safety \& efficacy of melasma treatment in various skin types using the Clear \& Brilliantt® Permea laser in combination with topical cysteamine.

Participants will

* Come into our office for an initial screening appointment to determine if participant is eligible for the study
* Come in for 3 laser treatments, 4 weeks apart, on 1 side of the face
* Use the study provided Cyspera topical cream every day on the entire face for the 12 weeks on the study.

Researchers will compare the side of the participants face not treated with laser to the side of the face treated with laser. The participants will be using Cyspera on both sides of their face.

Conditions

  • Melasma

Interventions

DEVICE

Fractional 1927nm Low-Powered Diode Laser

Clear \& Brilliant Permea® Laser used on the side of the face randomized to receive laser

OTHER

Topical Cysteamine

Topical Cysteamine cream will be used on the entire face.

Sponsors & Collaborators

  • Solta Medical

    collaborator INDUSTRY

  • Skin of Color Society

    collaborator UNKNOWN

  • Scientis

    collaborator UNKNOWN

  • UnionDerm

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
74 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-10-28
Primary Completion
2023-04-30
Completion
2023-07-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05656833 on ClinicalTrials.gov