A Randomized, Observer-Blinded, Placebo-Controlled Study on Safety and Efficacy of SM-030 in Adults With Melasma

Melasma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06454747
• Other study ID #: CT-214
• Status: Recruiting
• Phase: Phase 2
• Start date: June 6, 2024
• Est. completion date: July 2025

Study information

• Verified date: June 2024
• Source: DermBiont, Inc.
• Contact: Joanna Jay
• Phone: 510-607-8155
• Email: joanna.j[@]dermbiont.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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. Approximately 138 subjects who meet the eligibility criteria, notably with a clinical diagnosis of Melasma will be randomized in a 3:2:1 ratio to one of three treatment arms: SM-030 gel 0.64% (N=69), Placebo gel (N=46), or SM-030 gel 0.08% (N=23). Subjects will be competitively enrolled in Mexico and El Salvador across 5 sites (4 sites in Mexico and 1 in El Salvador). Subjects will be assessed for safety and efficacy at each visit.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 138
• Est. completion date: July 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria

Subjects must meet all of the following criteria to be included in the study:

1. Male or Female age 18-65 with Fitzpatrick skin type II through V and a clinical diagnosis of Melasma

2. Subjects 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 Score of at least 2 (hyperpigmentation at least moderately darker than surrounding normal skin

3. Ability to understand, agree to, and sign the study informed consent form (ICF).

4. For female or childbearing subjects, they must be on an agreeable form of birth control (oral contraceptive therapies, estrogen replacement therapies, other non-oral hormonal therapies, IUDs, be abstinent, or have a vasectomized partner) and who have not added and/or changed the method of birth control in the last 6 months, and have no intention of adjusting or changing the method of birth control

5. Agree to discontinue all agents used to treat hyperpigmentation, aging or exfoliate the skin during the course of the study. Makeup and moisturizers are permitted.

6. Agree not to change their sun exposure at work, home, or leisure and apply study supplied sunscreen daily.

7. Technical ability and willingness to apply Investigational product.

8. Willing to allow digital photos of treatment and comparison areas to be taken and stored.

9. Willing to apply study-supplied mineral sunscreen, moisturizer, and cleanser to the face daily throughout the duration of the study

Exclusion Criteria:

Subjects must meet all of the following criteria to be included in the study:

1. Male or Female age 18-65 with Fitzpatrick skin type II through V and a clinical diagnosis of Melasma

2. Subjects 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 Score of at least 2 (hyperpigmentation at least moderately darker than surrounding normal skin

3. Ability to understand, agree to, and sign the study informed consent form (ICF).

4. For female or childbearing subjects, they must be on an agreeable form of birth control (oral contraceptive therapies, estrogen replacement therapies, other non-oral hormonal therapies, IUDs, be abstinent, or have a vasectomized partner) and who have not added and/or changed the method of birth control in the last 6 months, and have no intention of adjusting or changing the method of birth control

5. Agree to discontinue all agents used to treat hyperpigmentation, aging or exfoliate the skin during the course of the study. Makeup and moisturizers are permitted.

6. Agree not to change their sun exposure at work, home, or leisure and apply study supplied sunscreen daily.

7. Technical ability and willingness to apply Investigational product.

8. Willing to allow digital photos of treatment and comparison areas to be taken and stored.

9. Willing to apply study-supplied mineral sunscreen, moisturizer, and cleanser to the face daily throughout the duration of the study

Related Conditions & MeSH terms

• Melanosis
• Melasma

Intervention

Drug:
• SM-030 gel 0.64%
Topical application to face twice daily for 12 weeks
• Placebo gel
Topical application to face twice daily for 12 weeks
• SM-030 gel 0.08%
Topical application to face twice daily for 12 weeks

Locations

Country	Name	City	State
El Salvador	Zepeda Dermatologia	Santa Tecla	La Libertad

Sponsors (2)

Lead Sponsor	Collaborator
DermBiont, Inc.	Fortrea

Country where clinical trial is conducted

El Salvador, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Investigator Assessment of Global Improvement (IAGI) for subjects receiving SM-030 compared to placebo	Superiority of each Active over Placebo based on proportion of subjects with a higher Investigator Assessment of Global Improvement at Week 12 compared to Baseline	12 weeks after first dose
Primary	Change in Investigator Assessment of Global Improvement (IAGI) for subjects receiving different SM-030 concentrations	Superiority of SM-030 gel 0.64% over SM-030 gel 0.08% based on proportion of subjects with a higher Investigator Assessment of Global Improvement at Week 12 compared to Baseline	12 weeks after first dose