Combination Topical Cysteamine and Fractional 1927nm Low-Powered Diode Laser for Treatment of Facial Melasma
NCT ID: NCT05656833
Last Updated: 2022-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
20 participants
INTERVENTIONAL
2022-10-28
2023-07-31
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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)
Fractional 1927nm Low-Powered Diode Laser
Clear \& Brilliant Permea® Laser used on the side of the face randomized to receive laser
Topical Cysteamine
Topical Cysteamine cream will be used on the entire face.
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).
Topical Cysteamine
Topical Cysteamine cream will be used on the entire face.
Interventions
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Fractional 1927nm Low-Powered Diode Laser
Clear \& Brilliant Permea® Laser used on the side of the face randomized to receive laser
Topical Cysteamine
Topical Cysteamine cream will be used on the entire face.
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
74 Years
ALL
Yes
Sponsors
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Solta Medical
INDUSTRY
Skin of Color Society
UNKNOWN
Scientis
UNKNOWN
UnionDerm
OTHER
Responsible Party
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Locations
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UnionDerm
New York, New York, United States
Countries
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Facility Contacts
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UnionDerm Research
Role: primary
Lauren Hoffmann, MD
Role: backup
Provided Documents
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Document Type: Study Protocol
Document Type: Informed Consent Form
Related Links
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Contact / Official Website for UnionDerm
Other Identifiers
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SterlingIRB Study #9727
Identifier Type: -
Identifier Source: org_study_id