Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:50 AM
Ignite Modification Date:
2025-12-25 @ 2:50 AM
NCT ID:
NCT05656833
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.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
74 Years
Study:
NCT05656833
Study Brief:
Protocol Section:
NCT05656833