Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Solta Medical | INDUSTRY |
| Skin of Color Society | UNKNOWN |
| Scientis | UNKNOWN |
Not provided
Not provided
Not provided
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
Participants will
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) |
|
| 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fractional 1927nm Low-Powered Diode Laser | Device | Clear & Brilliant Permea® Laser used on the side of the face randomized to receive laser |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 12 Weeks |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UnionDerm | Recruiting | New York | New York | 10003 | United States |
Not provided
| Label | URL |
|---|---|
| Contact / Official Website for UnionDerm | View source |
Not provided
Investigator has not decided on IPD sharing plan yet
Not provided
Not provided
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 11, 2022 | Dec 6, 2022 | Prot_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 11, 2022 | Dec 6, 2022 | ICF_001.pdf |
Not provided
| ID | Term |
|---|---|
| D008548 | Melanosis |
| D000072662 | Margins of Excision |
| ID | Term |
|---|---|
| D017495 | Hyperpigmentation |
| D010859 | Pigmentation Disorders |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D003543 | Cysteamine |
| ID | Term |
|---|---|
| D008624 | Mercaptoethylamines |
| D005021 | Ethylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
Not provided
Not provided
Single Center, Prospective, With Before-After Analysis
Not provided
Not provided
Photographic assessment by two blinded dermatologists will measure changes will assess improvement in melasma by mMASI score. In addition, an investigator quartile improvement score from baseline to week 12 (0 - 0%, no improvement; 76%-100% - very significant improvement) will be assessed.
| Topical Cysteamine | Other | Topical Cysteamine cream will be used on the entire face. |
|
| D065308 | Morphological and Microscopic Findings |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D013438 |
| Sulfhydryl Compounds |
| D013457 | Sulfur Compounds |