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Fractional Laser
Fractionated 1927nm Laser for Hyperpigmentation
N/A
Waitlist Available
Led By Jeffrey Kenkel, MD
Research Sponsored by University of Texas Southwestern Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 1 month and 3 months
Awards & highlights
Study Summary
This trial is testing a laser to treat hyperpigmentation in people with dark skin, to see if it is effective and safe.
Who is the study for?
Adults aged 18-75 with darker skin tones (Fitzpatrick Skin Phototypes V and VI) who have noticeable hyperpigmentation on their face and are seeking treatment. Participants must be willing to avoid other aesthetic treatments, follow study procedures, use approved birth control if applicable, and not have any health conditions that could interfere with the trial.Check my eligibility
What is being tested?
The trial is testing the effectiveness of a non-ablative fractionated laser therapy called MOXI for treating facial hyperpigmentation in individuals with darker skin types. It also aims to find a safe pre- and post-treatment skincare routine to prevent unwanted pigmentation or scarring.See study design
What are the potential side effects?
Potential side effects may include temporary redness, swelling at the treatment site, changes in skin pigmentation, discomfort during the procedure, or rare chances of scarring. The exact side effects will depend on individual reactions to laser therapy.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 1 month and 3 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 1 month and 3 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Skin Hyperpigmentation Index (SHI) Scores from baseline at 1 month
Skin
Change in brown spots and pigmentation from baseline in response to laser treatment at 1 month
+2 moreSecondary outcome measures
Adverse Events
Participant response to pre-post treatment regimens
Trial Design
2Treatment groups
Experimental Treatment
Group I: Healthy Participants- Pre-Ttreatment OnlyExperimental Treatment1 Intervention
Subjects who are interested in treatment for hyperpigmentation will be enrolled for this study.
Subjects will be pre-treated with tretinoin/hydroquinone prior to treatments. No post-treatment care.
Group II: Healthy Participants- Post-Treatment OnlyExperimental Treatment1 Intervention
Subjects who are interested in treatment for hyperpigmentation will be enrolled for this study.
Subjects will wash out of any topical medications and will receive treatment. Post-treatment care will include use of temovate for 4 days.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
MOXI
2022
N/A
~30
Find a Location
Who is running the clinical trial?
University of Texas Southwestern Medical CenterLead Sponsor
1,048 Previous Clinical Trials
1,053,715 Total Patients Enrolled
Jeffrey Kenkel, MDPrincipal InvestigatorUT Southwestern- Department of Plastic Surgery
12 Previous Clinical Trials
243 Total Patients Enrolled
Abby Culver, MDPrincipal InvestigatorUT Southwestern- Department of Plastic Surgery
1 Previous Clinical Trials
30 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a condition that could affect my skin's healing.I am able to understand instructions and give informed consent.I have no planned surgeries or hospital stays during the study.I've recently had surgery or a major injury in the area that needs treatment.I have severe or cystic acne on the area that needs treatment.I am younger than 18 or older than 75.I have had recent cosmetic treatments in the area to be treated.I am not on psychiatric drugs that affect my understanding.I haven't had skin treatments like microdermabrasion or glycolic acid in the last 4 weeks.I am willing and able to follow all study instructions and treatments.I have a history of diseases affecting my immune system.I agree not to undergo any cosmetic treatments not approved by the study during my participation.I have or had cancerous or pre-cancerous skin lesions in the area to be treated.I am between 18 and 75 years old and consider myself healthy.I am not on any treatments that could affect the study's results.I have significant scarring in the area that needs treatment.I do not have skin conditions in the treatment area that would exclude me.I am not pregnant, nursing, planning to become pregnant, immunocompromised, or using immunosuppressive medications/radiation.I do not have uncontrolled asthma, diabetes, thyroid issues, or significant high blood pressure.I have noticeable dark spots on my face and want them treated.I am using or willing to use an effective birth control method during the study.I am not pregnant, not breastfeeding, and will use birth control during the study.
Research Study Groups:
This trial has the following groups:- Group 1: Healthy Participants- Pre-Ttreatment Only
- Group 2: Healthy Participants- Post-Treatment Only
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Which individuals are allowed to register for this research study?
"Applicants must suffer from hyperpigmentation and be between 18 to 75 years old in order to qualify for this medical trial, which seeks a total of 10 participants."
Answered by AI
Is this experimental research actively seeking participants?
"According to the data presented on clinicaltrials.gov, this particular trial has ceased accepting new patients as of October 31st 2022 and is no longer actively recruiting. Nonetheless, there are 12 other experiments currently in need of participants that have recently been updated."
Answered by AI
Does this examination require participants to be of legal adult age?
"This trial is seeking patients aged 18 to 75. In addition, there are 11 other clinical trials directed at individuals below and above the age of 18 or 65 respectively."
Answered by AI
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