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Combination Topical Cysteamine and Fractional 1927nm Low-Powered Diode Laser for Treatment of Facial Melasma

Primary Purpose

Melasma

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Fractional 1927nm Low-Powered Diode Laser
Topical Cysteamine
Sponsored by
UnionDerm
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Melasma focused on measuring Facial Melasma, Cyspera, Clear & Brilliant Laser, Laser, Melasma

Eligibility Criteria

18 Years - 74 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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. 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.

Sites / Locations

  • UnionDermRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Fractional 1927nm Low-Powered Diode Laser combined with Topical Cysteamine

Topical Cysteamine Alone

Arm Description

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)

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).

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
December 6, 2022
Last Updated
December 15, 2022
Sponsor
UnionDerm
Collaborators
Solta Medical, Skin of Color Society, Scientis
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1. Study Identification

Unique Protocol Identification Number
NCT05656833
Brief Title
Combination Topical Cysteamine and Fractional 1927nm Low-Powered Diode Laser for Treatment of Facial Melasma
Official Title
Combination Topical Cysteamine and Fractional 1927nm Low-Powered Diode Laser
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 28, 2022 (Actual)
Primary Completion Date
April 2023 (Anticipated)
Study Completion Date
July 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UnionDerm
Collaborators
Solta Medical, Skin of Color Society, Scientis

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Melasma
Keywords
Facial Melasma, Cyspera, Clear & Brilliant Laser, Laser, Melasma

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Single Center, Prospective, With Before-After Analysis
Masking
Outcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Fractional 1927nm Low-Powered Diode Laser combined with Topical Cysteamine
Arm Type
Active Comparator
Arm Description
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)
Arm Title
Topical Cysteamine Alone
Arm Type
Active Comparator
Arm Description
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).
Intervention Type
Device
Intervention Name(s)
Fractional 1927nm Low-Powered Diode Laser
Intervention Description
Clear & Brilliant Permea® Laser used on the side of the face randomized to receive laser
Intervention Type
Other
Intervention Name(s)
Topical Cysteamine
Intervention Description
Topical Cysteamine cream will be used on the entire face.
Primary Outcome Measure Information:
Title
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.
Description
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
Time Frame
12 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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. 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.
Facility Information:
Facility Name
UnionDerm
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
UnionDerm Research
Phone
212-366-5400
Email
usld.research@gmail.com
First Name & Middle Initial & Last Name & Degree
Lauren Hoffmann, MD
Phone
(212) 366-5400
Email
usld.research@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
Investigator has not decided on IPD sharing plan yet
Links:
URL
https://www.unionderm.com/innovations/current-studies-and-clinical-trials/
Description
Contact / Official Website for UnionDerm

Learn more about this trial

Combination Topical Cysteamine and Fractional 1927nm Low-Powered Diode Laser for Treatment of Facial Melasma

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