MelasmaPhase 2NCT06454747
Randomized Study Using SM-030 Gel for Adults With Melasma
A Phase 2 study testing SM-030 gel 0.64% and SM-030 gel 0.08% in people with Melasma, run by DermBiont, Inc. at 2 sites in El Salvador.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Melasma
- What is being tested?
- SM-030 gel 0.64% and SM-030 gel 0.08%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 138 participants
- Where
- 2 sitesEl Salvador
- Study dates
- 27 Jun 2024to Oct 2025
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects must meet all of the following criteria to be included in the study:
- Subjects 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
- 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.
Show all 9Show fewer
- 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
Who cannot join
- Subjects 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.
Show all 20Show fewer
- 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 (TXA)), UV light therapy and sunbathing, topical retinoids.
- 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 months) 4. Systemic methotrexate (6 months) 5. Systemic tranexamic acid (TXA) 6. Systemic photoallergic, phototoxic, and or photosensitizing drugs (6 months including psoralens, sulfonamide drugs, tetracycline antibiotics, thiazide diuretics, phenothiazines, coal tar and derivatives, and tricyclic antidepressants, chlorpromazine, benoxaprofen, piroxicam, nalidixic acid, procainamide, phenytoin, antimalarial medications, some cystostatic agents)
- 9. Laser (ablative or non-ablative), microneedling, PRP, or light-based treatment of the treatment areas within 3 months of Screening.
- 10. Any dermatological conditions within the designated application area that could interfere with clinical evaluations or any disease state or physical condition which might expose the subject to an unacceptable risk by study participation (neurodermatitis, eczema, psoriasis, atrophy, rosacea, seborrheic dermatits, etc.).
- 11. Any underlying disease(s) or other dermatological conditions that require the use of exclusionary topical or systemic therapy (see Exclusion criteria 6, 7, and 8).
- 12. Known high daily exposure to the sun (>4 hours of sun exposure through work or daily activities) and/or frequent sunbathing/UV tanning.
- 13. Unwilling to discontinue applying any prescription or over the counter (OTC) topical product creams and ointments, other than makeup and moisturizers, on treatment area(s) at Baseline through their last day of study.
- 14. Treatment of any type of cancer within 6 months of Screening, with the exception of superficial skin cancers such as basal cell or squamous cell carcinoma outside of treatment area.
- 15. Known allergy to any of the Investigational product(s) or any components in the Investigational product(s) or history of hypersensitivity or allergic reactions to any of the study preparations as described in the Investigator's Brochure.
- 16. Unable to meet the study attendance requirements.
- 17. Any history of psychiatric disease or history of alcohol or drug abuse that would interfere with the ability to comply with the study protocol.
- 18. Participation in any other trial of an investigational drug or device within 30 days prior to enrollment or participation in a research study concurrent with this study.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
El Salvador2 sites, 2 recruiting
- Recruiting
Zepeda Dermatologia
Santa Tecla, La Libertad Department
David E Zepeda, MD
- Recruiting
Centro de Investigación y Desarrollo Brioso Ramirez
Santa Tecla, La Libertad, El Salvador
Jesus A Brioso Diaz, MD
About this study
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
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. 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.
- Conditions
- Melasma
- Being tested
- SM-030 gel 0.64%, Placebo gel, SM-030 gel 0.08%
- Medical subject headings
- Melanosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SM-030 gel 0.64%Drug
Topical application to face twice daily for 12 weeks.
Placebo gelDrug
Topical application to face twice daily for 12 weeks.
SM-030 gel 0.08%Drug
Topical application to face twice daily for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| SM-030 gel 0.64% | Experimental | Topical application of SM-030 gel 0.64% twice daily for 12 weeks and a 4-week additional safety follow-up period. Receives: Drug: SM-030 gel 0.64% |
| Placebo gel | Placebo comparator | Inactive comparator. Receives: Drug: Placebo gel |
| SM-030 gel 0.08% | Experimental | Topical application of SM-030 gel 0.08% twice daily for 12 weeks and a 4-week additional safety follow-up period. Receives: Drug: SM-030 gel 0.08% |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 lower Investigator Assessment of Global Improvement at Week 12 compared to Baseline. Minimum value 0 is best, or completely clear. Maximum value is 6, or worse and darker pigmentation.
Measured: 12 weeks after first dose
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 lower Investigator Assessment of Global Improvement at Week 12 compared to Baseline. Minimum value 0 is best, or completely clear. Maximum value is 6, or worse and darker pigmentation.
Measured: 12 weeks after first dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2024
- Study start27 Jun 2024
- Primary completionApr 2025 (estimated)
- Study completionOct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MelasmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized 3-arm tranche of main cohorts
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 138 participants (estimated)
Sponsor and investigators
- Lead sponsor
- DermBiont, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Daivd Zepeda, MD, Principal investigator, Zepeda Dermatologia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06454747
- Sponsor's protocol ID
- CT-214
- Status last verified
- Dec 2024
- First submitted
- 6 Jun 2024
- Last updated
- 13 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06454747
- Acronym / sponsor ID
- CT-214
- Conditions
- Melasma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 138 participants (estimated)
- Lead sponsor
- DermBiont, Inc.Industry (pharma, biotech, devices)
- Study start
- 27 Jun 2024 (actual)
- Primary completion
- Apr 2025 (estimated)
- Study completion
- Oct 2025 (estimated)
- First posted
- 12 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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. 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Randomized 3-arm tranche of main cohorts
| Arm | Type | Receives |
|---|---|---|
| SM-030 gel 0.64% | Experimental | Drug: SM-030 gel 0.64%Topical application of SM-030 gel 0.64% twice daily for 12 weeks and a 4-week additional safety follow-up period. |
| Placebo gel | Placebo comparator | Drug: Placebo gelInactive comparator. |
| SM-030 gel 0.08% | Experimental | Drug: SM-030 gel 0.08%Topical application of SM-030 gel 0.08% twice daily for 12 weeks and a 4-week additional safety follow-up period. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Subjects 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
- 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.
Key exclusion criteria (20 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SM-030 gel 0.64%Topical application to face twice daily for 12 weeks. | Drug | SM-030 gel 0.64% |
| Placebo gelTopical application to face twice daily for 12 weeks. | Drug | Placebo gel |
| SM-030 gel 0.08%Topical application to face twice daily for 12 weeks. | Drug | SM-030 gel 0.08% |
Primary outcome
Change in Investigator Assessment of Global Improvement (IAGI) for subjects receiving SM-030 compared to placebo
Time frame: 12 weeks after first dose
Superiority of each Active over Placebo based on proportion of subjects with a lower Investigator Assessment of Global Improvement at Week 12 compared to Baseline. Minimum value 0 is best, or completely clear. Maximum value is 6, or worse and darker pigmentation.
Change in Investigator Assessment of Global Improvement (IAGI) for subjects receiving different SM-030 concentrations
Time frame: 12 weeks after first dose
Superiority of SM-030 gel 0.64% over SM-030 gel 0.08% based on proportion of subjects with a lower Investigator Assessment of Global Improvement at Week 12 compared to Baseline. Minimum value 0 is best, or completely clear. Maximum value is 6, or worse and darker pigmentation.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2024.
Related trials for Melasma
Active, not recruitingPhase 4
Efficacy and Safety of Triple-Combination Cream Plus Microneedling Along With Tranexamic Acid Versus Platelet-Rich Plasma in the Treatment of Moderate-to-Severe Melasma: A Randomized Comparative Study
Melasma (Facial Melasma)
Not yet recruiting
COMPARISON OF TOPICAL VITAMIN C VS NIACINAMIDE IN TREATMENT OF MELASMA
Melasma
Not yet recruiting
New Treatment in Melasma
Female, With
Not yet recruitingPhase 4
Baseline Dermoscopic Vascular Score and Response to Oral Tranexamic Acid in Facial Melasma
Melasma
Active, not recruiting
Treatment and Prevention of Melasma Relapses by Using 1064nm 650 Microsecond Laser
Melasma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Daivd Zepeda, MD principal investigator
Zepeda Dermatologia
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SM-030 gel 0.64% and SM-030 gel 0.08% in people with Melasma, run by DermBiont, Inc. at 2 sites in El Salvador.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in El Salvador. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Joanna Jay (510-607-8155, joanna.j@dermbiont.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Investigator Assessment of Global Improvement (IAGI) for subjects receiving SM-030 compared to placebo (time frame: 12 weeks after first dose). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2024.