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

Melasma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05656833
• Other study ID #: SterlingIRB Study #9727
• Status: Recruiting
• Phase: N/A
• Start date: October 28, 2022
• Est. completion date: July 2023

Study information

• Verified date: December 2022
• Source: UnionDerm
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: July 2023
• Est. primary completion date: April 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 74 Years

Eligibility

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.

Related Conditions & MeSH terms

• Melanosis
• Melasma

Intervention

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.

Locations

Country	Name	City	State
United States	UnionDerm	New York	New York

Sponsors (4)

Lead Sponsor	Collaborator
UnionDerm	Scientis, Skin of Color Society, Solta Medical

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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

External Links

•   Contact / Official Website for UnionDerm