Combination Topical Cysteamine and Fractional 1927nm Low-Powered Diode Laser for Treatment of Facial Melasma
Melasma
About this trial
This is an interventional treatment trial for Melasma focused on measuring Facial Melasma, Cyspera, Clear & Brilliant Laser, Laser, Melasma
Eligibility Criteria
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.
Sites / Locations
- UnionDermRecruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
Fractional 1927nm Low-Powered Diode Laser combined with Topical Cysteamine
Topical Cysteamine Alone
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)
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).