Actively Recruiting
A Randomized, Observer-Blinded, Placebo-Controlled Study on the Safety and Efficacy of Twice Daily Application of SM-030 Gel 0.64% Vs. SM-030 Gel 0.08% Vs. Placebo Gel in Adults With Melasma
Led by DermBiont, Inc. · Updated on 2024-12-13
138
Participants Needed
2
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and efficacy of two different strengths of SM-030 gel compared to a placebo gel in adults diagnosed with Melasma, a skin condition causing dark patches. This phase 2b randomized, observer-blinded study includes healthy male and female participants with moderate to severe Melasma and Fitzpatrick skin types II through V. The study aims to understand how well the gel improves skin appearance over a 12-week treatment period. Participants will be assigned to one of three groups: SM-030 gel 0.64%, SM-030 gel 0.08%, or a placebo gel. Each participant will apply their assigned gel topically to the face twice daily for 12 weeks. Following this treatment period, there is a 4-week safety follow-up to monitor any side effects or changes. During the study, participants will visit the study sites regularly for safety and effectiveness assessments, including digital photos of the treatment areas. Researchers will measure changes in skin improvement using the Investigator Assessment of Global Improvement after 12 weeks. Participants will also apply study-supplied mineral sunscreen, moisturizer, and cleanser daily, and adherence to treatment and sun protection will be monitored throughout the study lasting approximately 16 weeks.
CONDITIONS
Brief Title
Randomized Study Using SM-030 Gel for Adults With Melasma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 18 to 65 years with Fitzpatrick skin type II through V
- Clinical diagnosis of moderate to severe Melasma stable for at least 3 months
- Melasma Severity Score of at least 2 with macular lesions that are not depressed or atrophic
- Ability to understand, agree to, and sign the informed consent form
- For females of childbearing potential, use of an acceptable birth control method without changes for 6 months and no plans to change
- Agreement to stop all skin treatments for hyperpigmentation, aging, or exfoliation during the study (makeup and moisturizers allowed)
- Agreement to maintain consistent sun exposure and apply study-supplied sunscreen daily
- Willingness and ability to apply the investigational product twice daily
- Consent to allow digital photos of treatment areas
- Willingness to use study-supplied mineral sunscreen, moisturizer, and cleanser daily throughout the study
You will not qualify if you...
- Positive pregnancy test, pregnant or lactating, or unwilling to use birth control during the study
- Other pigmentary disorders affecting treatment areas (e.g., vitiligo)
- Severe photodamage as assessed by a photo damage scale
- Diseases linked to hyperpigmentation like thyroid, liver, or adrenal disorders
- Use of tanning booths or phototherapy within 3 months before screening
- Use or past use of monobenzyl ether for skin depigmentation
- Use of certain topical products (corticosteroids, bleaching agents, retinoids) within 28 days before screening
- Use of systemic corticosteroids or other specified drugs within defined washout periods
- Laser, microneedling, PRP, or light-based treatments on study areas within 3 months before screening
- Dermatological conditions on the application area that could affect evaluations
- High daily sun exposure (>4 hours) or frequent sunbathing/UV tanning
- Inability or unwillingness to stop using other topical skin products except makeup and moisturizers
- Cancer treatment within 6 months except superficial skin cancers outside treatment areas
- Allergy or hypersensitivity to study products
- Inability to comply with study attendance
- History of psychiatric disease, alcohol, or drug abuse interfering with study compliance
- Participation in another investigational drug or device trial within 30 days prior to enrollment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 weeks
Participants apply the assigned SM-030 gel or placebo gel topically to the face twice daily.
Regular visits during treatment as scheduled by the study team
Duration - 4 weeks
Participants are monitored for safety after completing the treatment period.
1 follow-up visit (in-person)
Trial Site Locations
Total: 2 locations
1
Zepeda Dermatologia
Santa Tecla, La Libertad Department, El Salvador
Actively Recruiting
2
Centro de Investigación y Desarrollo Brioso Ramirez
Santa Tecla, La Libertad, El Salvador, El Salvador
Actively Recruiting
Research Team
J
Joanna Jay
E
Emma Taylor
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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