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

Sponsor

UnionDerm (Other)

Overall Status

Recruiting

CT.gov ID

NCT05656833

Collaborator

Solta Medical (Industry), Skin of Color Society (Other), Scientis (Other)

Enrollment

Location

Arms

8.1

Anticipated Duration (Months)

2.5

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Melasma	Device: Fractional 1927nm Low-Powered Diode Laser Other: Topical Cysteamine	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Single Center, Prospective, With Before-After AnalysisSingle Center, Prospective, With Before-After Analysis

Masking:

Single (Outcomes Assessor)

Masking Description:

Photographic assessment by two blinded dermatologists will measure changes will assess improvement in melasma by mMASI score. In addition, an investigator quartile improvement score from baseline to week 12 (0 - 0%, no improvement; 76%-100% - very significant improvement) will be assessed.

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Oct 28, 2022

Anticipated Primary Completion Date :

Apr 1, 2023

Anticipated Study Completion Date :

Jul 1, 2023

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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. [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 74 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.