BridgeMD
New treatment option for Melasma
Official title Randomized Study Using SM-030 Gel for Adults With Melasma
ClinicalTrials.gov ID: NCT06454747
What this study is testing
What is SM-030 gel 0.64%?
SM-030 gel 0.64% is an investigational medicine, given as an once-daily treatment applied to the skin, being studied as a potential treatment for melasma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Brief Summary This is a phase 2b, observer-blinded, randomized study that will evaluate the safety and efficacy of topically applied SM-030 gel 0.64% and SM-030 gel 0.08% compared against placebo gel in healthy adult male and female subjects with Melasma. The study will be comprised of a 12-week twice daily dosing period and a 4-week additional safety follow-up period.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65. Healthy volunteers may be eligible.
You may be able to join if
- people must meet all of the following criteria to be included in the study:
- people must meet all of the following criteria to be included in the study:
- Male or Female age 18-65 with Fitzpatrick skin type II through V and a clinical diagnosis of Melasma
- people with moderate to severe Melasma using the following guidelines: 1\. Stable (unchanged per subject reporting) melasma for at least 3 months 2...
You likely can't join if
- people who meet any of the following criteria will be excluded in the study:
- Positive urine pregnancy test, pregnant, lactating, or female of childbearing potential who does not agree to use an active method of birth control...
- Conditions at baseline that would interfere with evaluation of UV-tanned skin, especially other pigmentary disorders including, but not limited to...
- Severe photodamage as assessed by the 10-point photo damage assessment scale (Griffiths et al., 1992); (McKenzie et al., 2011).
- Presence of known concomitant diseases associated with the development of hyperpigmentation (e.g., thyroid, liver, adrenal).
- Current tanning booth exposure or any kind of phototherapy within 3 months of Screening.
See the full eligibility criteria
- people must meet all of the following criteria to be included in the study:
- people must meet all of the following criteria to be included in the study:
- Male or Female age 18-65 with Fitzpatrick skin type II through V and a clinical diagnosis of Melasma
- people with moderate to severe Melasma using the following guidelines: 1\. Stable (unchanged per subject reporting) melasma for at least 3 months 2. Macular lesions, neither depressed nor atrophic 3. Melasma Severity...
- people who meet any of the following criteria will be excluded in the study:
- Positive urine pregnancy test, pregnant, lactating, or female of childbearing potential who does not agree to use an active method of birth control for the duration of the study.
- Conditions at baseline that would interfere with evaluation of UV-tanned skin, especially other pigmentary disorders including, but not limited to vitiligo affecting the treatment and comparison sites.
- Severe photodamage as assessed by the 10-point photo damage assessment scale (Griffiths et al., 1992); (McKenzie et al., 2011).
- Presence of known concomitant diseases associated with the development of hyperpigmentation (e.g., thyroid, liver, adrenal).
- Current tanning booth exposure or any kind of phototherapy within 3 months of Screening.
- Current or past use of monobenzyl ether to depigment skin.
- Use of the following topical preparations within a 28-day washout period: topical corticosteroids, topical bleaching products (hyroquinone, niacinamide, kojic acid, ascorbic acid, chemical peels, topical tranexamic acid...
- Use of the following systemic agents within the specified washout periods: 1\. Systemic corticosteroids (28 days) 2. Systemic cyclosporine, interferon (6 months) 3. Systemic acitretin, etretinate, isotretinoin (6...
The study team makes the final eligibility decision.
Where it's taking place
- Santa Tecla, La Libertad Department, El Salvador
- Santa Tecla, La Libertad, El Salvador, El Salvador
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Santa Tecla, La Libertad Department, El Salvador; Santa Tecla, La Libertad, El Salvador, El Salvador. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.