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

December 15, 2022 updated by: UnionDerm

Combination Topical Cysteamine and Fractional 1927nm Low-Powered Diode Laser

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy subjects of Skin Type I-VI females.
  • Subjects must be between 18 and 74 years of age, and must have visible melasma on the face.
  • Subjects must read, understand, and sign the Informed Consent.
  • Subjects must be willing and able to comply with all follow-up requirements.

Exclusion Criteria:

  • Subjects must not have active or localized or systemic infections.
  • Subjects must not be immunocompromised.
  • Subjects must not have a coagulation disorder, and must not be using anticoagulation -medications.
  • Subjects must not have history of surgical or cosmetic treatment, including prior skin lightening agents, microneedling or microdermabrasion, or laser or light-based therapies, to the planned treatment areas in the prior 8 weeks.
  • Subjects must not have photosensitivity or allergy.
  • Subjects must not be mentally incompetent.
  • Subjects must not be pregnant or breastfeeding.
  • History of skin cancer or pre-cancerous lesions in the treatment area
  • Subjects must not be currently using aspirin or antioxidants.
  • Subjects must not refuse to sign the Informed Consent document and/or refuse to comply with all follow-up requirements.
  • Subjects must never have had gold therapy.
  • Subjects must never have had radiation therapy to the face. Recent or current suntan or sunburn within 2 weeks.
  • Clinically dysplastic nevi in the treatment area.
  • Subjects must not have had collagen, other methods of tissue augmentation, botox, chemical peels, dermabrasion, or resurfacing within the last year.
  • Oral retinoid (Accutane or Soriatane) or photosensitizing drugs, e.g. Declomycin®, a tetracycline with light absorption in the range of 400 to 450 nm use within 24 months of study entry.
  • Topical retinoid therapy on face within one month of study entry.
  • History of keloids or hypertrophic scars
  • A history of cutaneous photosensitization, porphyria, hypersensitivity to porphyrins, or photodermatosis.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Fractional 1927nm Low-Powered Diode Laser combined with Topical Cysteamine
One side of the face of participants will be randomized to receive fractional 1927nm Low-Powered Diode Laser in combination with topical cysteamine. There are 3 total treatments with the laser, in combination with using the topical cysteamine cream every day for the duration of the study (12 weeks)
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.
Active Comparator: Topical Cysteamine Alone
The other side of the face that is not randomized to receive laser treatment will be subject to treatment with the topical cysteamine cream alone. Participants will use the topical cysteamine cream every day for the duration of the study (12 weeks).
Other: Topical Cysteamine
Topical Cysteamine cream will be used on the entire face.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 alone in the treatment of melasma.
Time Frame: 12 Weeks
Photographic assessment by two blinded dermatologists will measure changes will assess improvement in melasma by modified Melasma Area and Involvement Index (mMASI). Total mMASI score ranges from 0 - 24, with a higher score indicating more involvement and/or severity of melasma
12 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

UnionDerm

Collaborators

Skin of Color Society
Solta Medical
Scientis

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 28, 2022

Primary Completion (Anticipated)

April 1, 2023

Study Completion (Anticipated)

July 1, 2023

Study Registration Dates

First Submitted

December 6, 2022

First Submitted That Met QC Criteria

December 15, 2022

First Posted (Actual)

December 19, 2022

Study Record Updates

Last Update Posted (Actual)

December 19, 2022

Last Update Submitted That Met QC Criteria

December 15, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SterlingIRB Study #9727

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

Investigator has not decided on IPD sharing plan yet

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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