Topical Cysteamine + Laser for Melasma

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: UnionDerm

Must be taking: Cyspera cream

Must not be taking: Anticoagulants, Aspirin, Antioxidants, Retinoids

Disqualifiers: Infections, Immunocompromised, Skin cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether combining a special laser treatment (Fractional 1927nm Low-Powered Diode Laser) with a topical cream called cysteamine is more effective for treating facial melasma (a common skin condition causing dark patches) than using the cream alone. Researchers aim to determine if the laser enhances the reduction of dark spots. Participants will apply the cream to their entire face and receive laser treatment on one side, allowing researchers to compare results. This trial may suit women with visible melasma who are willing to adhere to the treatment schedule and attend clinic visits for laser sessions. As an unphased trial, it offers participants the chance to contribute to innovative research that could lead to new treatment options for melasma.

Will I have to stop taking my current medications?

The trial requires that you stop using certain medications, such as anticoagulants, aspirin, antioxidants, oral retinoids, and topical retinoids before participating. If you are using any of these, you will need to stop them for a specified period before joining the study.

What prior data suggests that this combination treatment is safe for melasma?

Previous studies have shown that using topical cysteamine is safe for treating melasma, a skin condition with dark patches. Many patients have reported no significant side effects, and research indicates that most people tolerate it well.

For the combination treatment with the fractional 1927nm low-powered diode laser and topical cysteamine, the laser is commonly used in skin treatments. The trial phase is "Not Applicable," indicating limited data on this specific combination. However, the laser is non-ablative, meaning it is gentle on the skin.

Overall, both treatments in the study—using topical cysteamine alone and with the laser—appear safe, with minimal side effects reported in other studies. Participants can feel confident about the safety of these treatments based on existing evidence. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this treatment combination for facial melasma because it combines a novel approach using a fractional 1927nm low-powered diode laser with topical cysteamine. Unlike traditional treatments like hydroquinone, which mainly work by lightening the skin, this combination aims to enhance the skin's natural repair mechanisms and improve pigmentation. The laser stimulates the skin at a cellular level while the cysteamine cream works to reduce oxidative stress and melanin production, potentially offering a more comprehensive and effective solution. Additionally, this dual approach might provide faster and more sustained results compared to standard topical treatments alone.

What evidence suggests that the combination of topical cysteamine and the Clear & Brilliant® Permea laser is effective for treating melasma?

Studies have shown that cysteamine cream effectively treats melasma, a condition causing dark patches on the skin. This cream reduces these patches with minimal side effects. A review of several studies found that a 5% cysteamine cream can significantly lighten these spots. Additionally, research indicates that a fractional 1927nm laser effectively improves skin damage and may help treat melasma. In this trial, one side of participants' faces will receive the combination of the fractional 1927nm laser with cysteamine cream, while the other side will receive cysteamine cream alone. Combining the laser with cysteamine cream could enhance results, as each treatment works differently. The laser improves skin texture, while cysteamine lightens dark spots. This combined approach could offer a more comprehensive treatment for melasma. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

Inclusion Criteria

Subjects must be willing and able to comply with all follow-up requirements.

Women with skin of any color or tone are eligible to participate.

Subjects must read, understand, and sign the Informed Consent.

Exclusion Criteria

Clinically dysplastic nevi in the treatment area.

Subjects must not be immunocompromised.

Subjects must not have a coagulation disorder, and must not be using anticoagulation -medications.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 visit

1 visit (in-person)

Treatment

Participants receive 3 laser treatments, 4 weeks apart, on one side of the face and use Cyspera topical cream daily for 12 weeks

12 weeks

3 visits (in-person) for laser treatments

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Fractional 1927nm Low-Powered Diode Laser
• Topical Cysteamine

How Is the Trial Designed?

Group I: Fractional 1927nm Low-Powered Diode Laser combined with Topical Cysteamine Active Control 2 Interventions

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)

Group II: Topical Cysteamine Alone Active Control 1 Intervention

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).

Who Is Running the Clinical Trial?

UnionDerm

Lead Sponsor

Trials

1

Recruited

20+

Solta Medical

Industry Sponsor

Trials

8

Recruited

210+

Skin of Color Society

Collaborator

Trials

2

Recruited

30+

Scientis

Collaborator

Trials

1

Recruited

20+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05656833

Combination Topical Cysteamine and Fractional 1927nm ... The primary objective of our study is to determine the efficacy of combined topical cysteamine cream with a 1927 diode non-ablative laser (Clear ...

2. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT05656833?term=CYSTEAMINE&draw=2&rank=1

Combination Topical Cysteamine and Fractional 1927nm ... An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during a clinical study or within a certain amount of ...

3. withpower.com withpower.com/trial/phase-melanosis-9-2022-7f363

Combination Topical Cysteamine and Fractional 1927nm ... This trial is testing if a combination of a special cream and a laser treatment works better for treating dark patches on the face compared to using the ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36950878/

Investigating the efficacy of a fractionated 1927 nm laser for ... These results demonstrate that fractionated, nonablative 1927 nm laser treatment is an effective modality for improving clinical and subclinical photodamage.

5. aging.networkofcare.org aging.networkofcare.org/sanmateo/CommunityResources/ClinicalTrials/Detail/NCT05656833?keyword=%22Laser%22

Combination Topical Cysteamine and Fractional 1927nm ... The primary objective of our study is to determine the efficacy of combined topical cysteamine cream with a 1927 diode non-ablative laser (Clear + Brilliant ...

6. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/33/NCT05656833/ICF_001.pdf

Combination Topical Cysteamine and Fractional 1927nm Low ... STUDY: Combination Topical Cysteamine and Fractional 1927nm Low Powered Diode Laser ... Topical cysteamine is a safe and well tolerated ... If the data ...