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

Launched by UNIONDERM · Dec 15, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new way to treat melasma, a skin condition that causes dark patches on the face. The researchers want to see if using a topical cream called cysteamine along with a special laser treatment (Clear + Brilliant Permea) is more effective than just using the cream alone. They are looking for healthy women and men aged 18 to 74 who have visible melasma on their faces. Participants will need to come to the clinic for an initial screening to see if they qualify and then receive three laser treatments on one side of their face, spaced four weeks apart. They will also apply the cysteamine cream daily to both sides of their face for 12 weeks.

During the study, researchers will compare the treated side of the face to the untreated side to evaluate the effectiveness and safety of the combined treatment. It's important to note that certain individuals, such as those with specific skin conditions, recent cosmetic procedures, or who are pregnant or breastfeeding, may not be eligible to participate. If you’re interested and think you might qualify, please talk to your healthcare provider for more information.

Gender

ALL

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.