MelasmaNCT05656833
Combination Topical Cysteamine and Fractional 1927nm Low-Powered Diode Laser for Treatment of Facial Melasma
A study testing Fractional 1927nm Low-Powered Diode Laser and Topical Cysteamine in people with Melasma, run by UnionDerm at 1 site in United States.
Trial summary
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 Permea®; Solta Medical, Inc.), compared to topical cysteamine (Cyspera) alone in the treatment of melasma. Read more about this study
- Who is it for?
- Ages 18 to 74 yearsHealthy volunteers can take part
- Conditions the study is for
- Melasma
- What is being tested?
- Fractional 1927nm Low-Powered Diode Laser and Topical Cysteamine
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Oct 2022to Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 74 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy subjects of Skin Type I-VI females.
- Subjects must be between 18 and 74 years of age, and must have visible melasma on the face.
- Subjects must read, understand, and sign the Informed Consent.
- Subjects must be willing and able to comply with all follow-up requirements.
Who cannot join
- Subjects must not have active or localized or systemic infections.
- Subjects must not be immunocompromised.
- Subjects must not have a coagulation disorder, and must not be using anticoagulation -medications.
- Subjects must not have history of surgical or cosmetic treatment, including prior skin lightening agents, microneedling or microdermabrasion, or laser or light-based therapies, to the planned treatment areas in the prior 8 weeks.
- Subjects must not have photosensitivity or allergy.
- Subjects must not be mentally incompetent.
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- Subjects must not be pregnant or breastfeeding.
- History of skin cancer or pre-cancerous lesions in the treatment area
- Subjects must not be currently using aspirin or antioxidants.
- Subjects must not refuse to sign the Informed Consent document and/or refuse to comply with all follow-up requirements.
- Subjects must never have had gold therapy.
- Subjects must never have had radiation therapy to the face. Recent or current suntan or sunburn within 2 weeks.
- Clinically dysplastic nevi in the treatment area.
- Subjects must not have had collagen, other methods of tissue augmentation, botox, chemical peels, dermabrasion, or resurfacing within the last year.
- Oral retinoid (Accutane or Soriatane) or photosensitizing drugs, e.g. Declomycin®, a tetracycline with light absorption in the range of 400 to 450 nm use within 24 months of study entry.
- Topical retinoid therapy on face within one month of study entry.
- History of keloids or hypertrophic scars
- A history of cutaneous photosensitization, porphyria, hypersensitivity to porphyrins, or photodermatosis.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
UnionDerm
New York, New York, 10003
UnionDerm Research, 212-366-5400, usld.research@gmail.com
Lauren Hoffmann, MD, (212) 366-5400, usld.research@gmail.com
About this study
Official title: Combination Topical Cysteamine and Fractional 1927nm Low-Powered Diode Laser
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 Permea®; Solta Medical, Inc.), compared to topical cysteamine (Cyspera) alone in the treatment of melasma.
The main questions it aims to answer are
Read more
- If melasma treatment with topical cysteamine cream is more effective when used with the Clear \& Brilliant® Permea laser
- The safety \& efficacy of melasma treatment in various skin types using the Clear \& Brilliantt® Permea laser in combination with topical cysteamine.
Participants will
- Come into our office for an initial screening appointment to determine if participant is eligible for the study
- Come in for 3 laser treatments, 4 weeks apart, on 1 side of the face
- Use the study provided Cyspera topical cream every day on the entire face for the 12 weeks on the study.
Researchers will compare the side of the participants face not treated with laser to the side of the face treated with laser. The participants will be using Cyspera on both sides of their face.
- Conditions
- Melasma
- Being tested
- Fractional 1927nm Low-Powered Diode Laser, Topical Cysteamine
- Keywords
- Facial Melasma, Cyspera, Clear & Brilliant Laser, Laser, Melasma
- Medical subject headings
- Melanosis, Margins of Excision
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fractional 1927nm Low-Powered Diode LaserDevice
Clear \& Brilliant Permea® Laser used on the side of the face randomized to receive laser
Topical CysteamineOther
Topical Cysteamine cream will be used on the entire face.
| Study group | Role | What they receive |
|---|---|---|
| Fractional 1927nm Low-Powered Diode Laser combined with Topical Cysteamine | Active comparator | 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) Receives: Device: Fractional 1927nm Low-Powered Diode Laser; Other: Topical Cysteamine |
| Topical Cysteamine Alone | Active comparator | 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). Receives: Other: Topical Cysteamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 Permea®; Solta Medical, Inc.), compared to topical cysteamine alone in the treatment of melasma.
Photographic assessment by two blinded dermatologists will measure changes will assess improvement in melasma by modified Melasma Area and Involvement Index (mMASI). Total mMASI score ranges from 0 - 24, with a higher score indicating more involvement and/or severity of melasma
Measured: 12 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2022
- Study start28 Oct 2022
- Primary completionApr 2023 (estimated)
- Study completionJul 2023 (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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single Center, Prospective, With Before-After Analysis
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- UnionDerm
- Sponsor type
- University, hospital or other
- Collaborators
- Solta Medical, Skin of Color Society, Scientis
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05656833
- Sponsor's protocol ID
- SterlingIRB Study #9727
- Status last verified
- Dec 2022
- First submitted
- 6 Dec 2022
- Last updated
- 19 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: Investigator has not decided on IPD sharing plan yet
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combination Topical Cysteamine and Fractional 1927nm Low-Powered Diode Laser
- ClinicalTrials.gov ID
- NCT05656833
- Acronym / sponsor ID
- SterlingIRB Study #9727
- Conditions
- Melasma
- Keywords
- Facial Melasma, Cyspera, Clear & Brilliant Laser, Laser, Melasma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- UnionDermUniversity, hospital or other
- Collaborators
- Solta Medical, Skin of Color Society, Scientis
- Study start
- 28 Oct 2022 (actual)
- Primary completion
- Apr 2023 (estimated)
- Study completion
- Jul 2023 (estimated)
- First posted
- 19 Dec 2022 (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.
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 Permea®; Solta Medical, Inc.), compared to topical cysteamine (Cyspera) alone in the treatment of melasma.
The main questions it aims to answer are
- If melasma treatment with topical cysteamine cream is more effective when used with the Clear \& Brilliant® Permea laser
- The safety \& efficacy of melasma treatment in various skin types using the Clear \& Brilliantt® Permea laser in combination with topical cysteamine.
Participants will
- Come into our office for an initial screening appointment to determine if participant is eligible for the study
- Come in for 3 laser treatments, 4 weeks apart, on 1 side of the face
- Use the study provided Cyspera topical cream every day on the entire face for the 12 weeks on the study.
Researchers will compare the side of the participants face not treated with laser to the side of the face treated with laser. The participants will be using Cyspera on both sides of their face.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Single Center, Prospective, With Before-After Analysis
| Arm | Type | Receives |
|---|---|---|
| Fractional 1927nm Low-Powered Diode Laser combined with Topical Cysteamine | Active comparator | Device: Fractional 1927nm Low-Powered Diode Laser, Other: Topical CysteamineOne 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) |
| Topical Cysteamine Alone | Active comparator | Other: Topical CysteamineThe 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 may qualify
- Ages
- 18 to 74 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Healthy subjects of Skin Type I-VI females.
- Subjects must be between 18 and 74 years of age, and must have visible melasma on the face.
- Subjects must read, understand, and sign the Informed Consent.
- Subjects must be willing and able to comply with all follow-up requirements.
Key exclusion criteria (18 listed)
- Subjects must not have active or localized or systemic infections.
- Subjects must not be immunocompromised.
- Subjects must not have a coagulation disorder, and must not be using anticoagulation -medications.
- Subjects must not have history of surgical or cosmetic treatment, including prior skin lightening agents, microneedling or microdermabrasion, or laser or light-based therapies, to the planned treatment areas in the prior 8 weeks.
- Subjects must not have photosensitivity or allergy.
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 |
|---|---|---|
| Fractional 1927nm Low-Powered Diode LaserClear \& Brilliant Permea® Laser used on the side of the face randomized to receive laser | Device | Fractional 1927nm Low-Powered Diode Laser combined with Topical Cysteamine |
| Topical CysteamineTopical Cysteamine cream will be used on the entire face. | Other | Fractional 1927nm Low-Powered Diode Laser combined with Topical Cysteamine, Topical Cysteamine Alone |
Primary outcome
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 Permea®; Solta Medical, Inc.), compared to topical cysteamine alone in the treatment of melasma.
Time frame: 12 Weeks
Photographic assessment by two blinded dermatologists will measure changes will assess improvement in melasma by modified Melasma Area and Involvement Index (mMASI). Total mMASI score ranges from 0 - 24, with a higher score indicating more involvement and/or severity of melasma
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2022.
- Contact / Official Website for UnionDermLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. Investigator has not decided on IPD sharing plan yet
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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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fractional 1927nm Low-Powered Diode Laser and Topical Cysteamine in people with Melasma, run by UnionDerm at 1 site in United States.
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 4 inclusion and 18 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: status not confirmed, as of the sponsor's last update on 19 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 Permea®; Solta Medical, Inc.), compared to topical cysteamine alone in the treatment of melasma. (time frame: 12 Weeks). 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 19 Dec 2022.