HyperpigmentationNCT05493280
Fractionated 1927nm Laser for Hyperpigmentation in Fitzpatrick Skin Phototypes V and VI
A study testing MOXI in people with Hyperpigmentation, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial summary
The primary objective of this study is to assess the efficacy of 1927nm non-ablative fractionated laser therapy to treat hyperpigmentation in patients ages 18-75 with Fitzpatrick Skin Phototypes V and VI and explore an effective, adjunctive pre- and post-procedural regimen to prevent iatrogenic dyspigmentation or… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Hyperpigmentation
- What is being tested?
- MOXI
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Nov 2022to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy male, female, and non-binary adults between 18 and 75 years of age
- Fitzpatrick Skin Phototype V and VI
- Individuals deemed by the Investigator to have clinically significant hyperpigmentation on their face and desire treatment and correction of this condition
- Individuals willing to withhold aesthetic therapies (excluding those explicitly prescribed by the Investigator as pre-treatment) for the duration of the study
- Women of childbearing potential who agree to take a urine pregnancy test at the Screening visit or when deemed by Investigator. Women of childbearing potential must have a negative urine pregnancy test and must not be lactating at Screening. Women must be willing and able to use an acceptable method of birth control (see below) during the study. Women will not be considered of childbearing potential if one or more of the following is documented:
- Postmenopausal for 12 months prior to initiation of the study
Show all 17Show fewer
- Without a uterus +/- both ovaries prior to initiation of the study
- Bilateral tubal ligation 6 months prior to initiation of the study
- Individuals of childbearing potential who use an acceptable method of contraception for the duration of the study. Acceptable modes of birth control include the following:
- Established use of hormonal contraception (oral, injectable, implanted, patch or vaginal ring)
- Barrier methods with spermicide: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository
- Intrauterine device (IUD) or intrauterine system (IUS)
- Surgical sterilization (e.g., vasectomy confirmed to be effective by sperm count check, tubal occlusion, hysterectomy, bilateral salpingectomy/oophorectomy)
- Abstinence from heterosexual intercourse, when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal methods are not acceptable forms of contraception.
- Individuals who can read, speak, write, and understand English and who are willing to provide written informed consent.
- Individuals willing to sign a photography release.
- Individuals willing and able to cooperate with all study requirements for the duration of the study, including prescribed pre- and post-procedure topical regimens
Who cannot join
- Ages < 18 or > 75 years old
- Fitzpatrick Skin Phototypes I-IV
- Known history of allergies or irritant contact dermatitis in response to general skin care products, including Hydroquinone and Retinol
- Known allergies or irritant contact dermatitis in response to common ingredients of physical sunscreen, including but not limited to Zinc Oxide
- Known allergies or irritant contact dermatitis to topical anesthetics, including Benzocaine and Tetracaine.
- Active local or systemic disorders that may affect wound healing or integrity of the integumentary system
Show all 32Show fewer
- History of active or inactive systemic granulomatous disease, (e.g., Sarcoidosis, Tuberculosis, Granulomatosis with Polyangiitis, etc.), or connective tissue disorders (e.g., Systemic Lupus Erythematosus, Dermatomyositis, Scleroderma, etc.)
- Recent history of surgery or significant trauma to the area(s) to be treated
- Significant scarring (excluding acne scars) in the area(s) to be treated
- Current or history of hypertrophic scarring or keloid scars
- Severe or cystic and clinically active acne on the area(s) to be treated
- Tattoos in the area(s) to be treated
- Individuals who currently have cancerous or pre-cancerous lesions in the area(s) to be treated and/or have a history of skin cancer
- Individuals with skin pathology and/or pre-existing dermatologic condition in the treatment area (i.e., psoriasis, rosacea, eczema, seborrheic dermatitis, vitiligo, hyper or hypo-skin pigmentation conditions such as post inflammatory hyperpigmentation) that the Investigator deems inappropriate for participation or could interfere with outcomes of the study.
- History of chronic drug or alcohol use.
- Microdermabrasion or glycolic acid treatment to the treatment area(s) within 4 weeks of study participation or who plan on having this treatment during the study.
- History of the following cosmetic treatments in the area(s) to be treated:
- Injectable filler of any type within the past 2 weeks
- Neurotoxins within the past week
- Ablative resurfacing laser treatment within the past 6 months
- Non-ablative, rejuvenating laser or light treatment within the past 6 months
- Chemical peel or dermabrasion within the past 3 months
- Individuals undergoing concurrent therapy that, in the Investigator's opinion, would interfere with the evaluation of the safety or efficacy of the study devices:
- Antiplatelet agents/anticoagulants (Coumadin, Heparin, Plavix, chronic NSAID use), and/or
- Psychiatric drugs that, in the Investigator's opinion, would impair the subject from understanding protocol requirements or understanding and signing consent.
- Individuals who are pregnant or nursing or those planning on becoming pregnant during the study according to self-report.
- Immunocompromised individuals or those currently using immunosuppressive medications and/or radiation.
- Individuals with uncontrolled disease such as asthma, diabetes, hyperthyroidism, medically significant hypertension, or hypothyroidism. Those with multiple health conditions may still be excluded from participation even if conditions are controlled.
- Individuals with any planned surgeries, overnight hospitalization, and/or invasive medical procedures planned during the study.
- Individuals who, in the Investigator's opinion, have a history of poor cooperation, unreliability or noncompliance with medical treatment.
- Individuals who are unable to understand instructions or give informed consent
- Individuals who have physical or psychological conditions which, in the opinion of the Investigator, makes them unable to complete the study per protocol (e.g., not likely to avoid other cosmetic treatments to area; not likely to stay in study for entire duration due to other commitments; or those with concomitant conditions that may develop symptoms that might confuse or confound study treatments or assessments).
Trial locations and contacts
1 site in 1 country.
United States1 site
UT Southwestern Medical Center- Dept of Plastic Surgery
Dallas, Texas, 75390
About this study
Official title: Quantifying Hyperpigmentation Response to Fractionated 1927nm in Fitzpatrick Skin Phototype V and VI: A Pilot Study
The primary objective of this study is to assess the efficacy of 1927nm non-ablative fractionated laser therapy to treat hyperpigmentation in patients ages 18-75 with Fitzpatrick Skin Phototypes V and VI and explore an effective, adjunctive pre- and post-procedural regimen to prevent iatrogenic dyspigmentation or scarring in this population.
Read the detailed description
This single-center clinical trial is being conducted over the course of 7 months, including one Initial Screening Visit (-42 to -28 Days) and three treatments (Day 0, Day 30, Day 60) followed by 1-month and 3-month follow-up visits (Day 90 and Day 120). The primary objective of this study is to assess the efficacy of 1927nm non-ablative fractionated laser therapy to treat hyperpigmentation in patients ages 18-75 with Fitzpatrick Skin Phototypes V and VI and explore an effective, adjunctive pre- and post-procedural regimen to prevent iatrogenic dyspigmentation or scarring in this population.
The Investigators will explore this question with a non-blinded, pilot study at a single center.
- Conditions
- Hyperpigmentation
- Being tested
- MOXI
- Medical subject headings
- Hyperpigmentation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MOXIDevice
Patients will receive treatment using f1927 devices and will be treated over the affected areas, once each month for a total of three months.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Participants- Pre-Ttreatment Only | Other | 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. Receives: Device: MOXI |
| Healthy Participants- Post-Treatment Only | Other | 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. Receives: Device: MOXI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Spots - Front of Face (Part 1)
Quantitively assessment of change in overall spots using measurements provided VISIA 3D analysis of front face
Count- the number of individual features detected in the region of interest.
Measured: Baseline, 1 Month and 3 Months
Change in Spots - Front of Face (Part 2)
Quantitively assessment of change in overall spots using measurements provided VISIA 3D analysis of front face
Count- the number of individual features detected in the region of interest.
Measured: Baseline, 1 Month and 3 Months
Change in Spots- Left Side of Face (Part 1)
Quantitively assessment of change in overall spots using measurements provided VISIA 3D analysis of left side of face
Count= the number if individual features detected in the region of interest.
Measured: Baseline, 1 Month and 3 Months
Change in Spots- Left Side of Face (Part 2)
Quantitively assessment of change in overall spots using measurements provided VISIA 3D analysis of left side of face
Count= the number if individual features detected in the region of interest.
Measured: Baseline, 1 Month and 3 Months
Change in Spots- Right Side of Face (Part 1)
Quantitively assessment of change in overall spots using measurements provided VISIA 3D analysis of right side of face
Count= the number if individual features detected in the region of interest.
Measured: Baseline, 1 Month and 3 Months
Change in Spots- Right Side of Face (Part 2)
Quantitively assessment of change in overall spots using measurements provided VISIA 3D analysis of right side of face
Count= the number if individual features detected in the region of interest.
Measured: Baseline, 1 Month and 3 Months
Change in UV Spots- Front of Face (Part 1)
Quantitively assessment of change in overall UV spots using measurements provided VISIA 3D analysis of front side of face Count= the number if individual features detected in the region of interest.
Measured: Baseline, 1 Month and 3 Months
Change in UV Spots- Front of Face (Part 2)
Quantitively assessment of change in overall UV spots using measurements provided VISIA 3D analysis of front side of face Count= the number if individual features detected in the region of interest.
Measured: Baseline, 1 Month and 3 Months
Change in UV Spots- Left of Face (Part 1)
Quantitively assessment of change in overall UV spots using measurements provided VISIA 3D analysis of left side of the face
Count= the number if individual features detected in the region of interest.
Measured: Baseline, 1 Month and 3 Months
Change in UV Spots- Left of Face (Part 2)
Quantitively assessment of change in overall UV spots using measurements provided VISIA 3D analysis of left side of the face
Count= the number if individual features detected in the region of interest.
Measured: Baseline, 1 Month and 3 Months
Change in UV Spots- Right Side if Face (Part 1)
Quantitively assessment of change in overall UV spots using measurements provided VISIA 3D analysis of right side of face
Count= the number if individual features detected in the region of interest.
Measured: Baseline, 1 Month and 3 Months
Change in UV Spots- Right Side if Face (Part 2)
Quantitively assessment of change in overall UV spots using measurements provided VISIA 3D analysis of right side of face
Count= the number if individual features detected in the region of interest.
Measured: Baseline, 1 Month and 3 Months
Change in Brown Spots- Front of Face (Part 1)
Quantitively assessment of change in overall UV spots using measurements provided VISIA 3D analysis of front of face
Count= the number if individual features detected in the region of interest.
Measured: Baseline, 1 Month and 3 Months
Change in Brown Spots- Front of Face (Part 2)
Quantitively assessment of change in overall UV spots using measurements provided VISIA 3D analysis of front of face
Count= the number if individual features detected in the region of interest.
Measured: Baseline, 1 Month and 3 Months
Change in Brown Spots- Left of Face (Part 1)
Quantitively assessment of change in overall UV spots using measurements provided VISIA 3D analysis of left side of face
Count= the number if individual features detected in the region of interest.
Measured: Baseline, 1 Month and 3 Months
Change in Brown Spots- Left of Face (Part 2)
Quantitively assessment of change in overall UV spots using measurements provided VISIA 3D analysis of left side of face
Count= the number if individual features detected in the region of interest.
Measured: Baseline, 1 Month and 3 Months
Change in Brown Spots- Right Side of Face (Part 1)
Quantitively assessment of change in overall UV spots using measurements provided VISIA 3D analysis of right side of face
Count= the number if individual features detected in the region of interest.
Measured: Baseline, 1 Month and 3 Months
Change in Brown Spots- Right Side of Face (Part 2)
Quantitively assessment of change in overall UV spots using measurements provided VISIA 3D analysis of right side of face
Count= the number if individual features detected in the region of interest.
Measured: Baseline, 1 Month and 3 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2022
- Study start14 Nov 2022
- Primary completion26 Jul 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HyperpigmentationStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeffrey M. Kenkel, University of Texas Southwestern Medical Center
- Investigators
- Jeffrey Kenkel, MD, Principal investigator, UT Southwestern- Department of Plastic Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05493280
- Sponsor's protocol ID
- STU-2022-0672
- Status last verified
- Nov 2025
- First submitted
- 4 Aug 2022
- Last updated
- 15 Dec 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantifying Hyperpigmentation Response to Fractionated 1927nm in Fitzpatrick Skin Phototype V and VI: A Pilot Study
- ClinicalTrials.gov ID
- NCT05493280
- Acronym / sponsor ID
- STU-2022-0672
- Conditions
- Hyperpigmentation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- 14 Nov 2022 (actual)
- Primary completion
- 26 Jul 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 9 Aug 2022 (actual)
- Results
- Posted 14 Nov 2025
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 this study is to assess the efficacy of 1927nm non-ablative fractionated laser therapy to treat hyperpigmentation in patients ages 18-75 with Fitzpatrick Skin Phototypes V and VI and explore an effective, adjunctive pre- and post-procedural regimen to prevent iatrogenic dyspigmentation or scarring in this population.
Detailed description
This single-center clinical trial is being conducted over the course of 7 months, including one Initial Screening Visit (-42 to -28 Days) and three treatments (Day 0, Day 30, Day 60) followed by 1-month and 3-month follow-up visits (Day 90 and Day 120). The primary objective of this study is to assess the efficacy of 1927nm non-ablative fractionated laser therapy to treat hyperpigmentation in patients ages 18-75 with Fitzpatrick Skin Phototypes V and VI and explore an effective, adjunctive pre- and post-procedural regimen to prevent iatrogenic dyspigmentation or scarring in this population.
The Investigators will explore this question with a non-blinded, pilot study at a single center.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy Participants- Pre-Ttreatment Only | Other | Device: MOXISubjects 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. |
| Healthy Participants- Post-Treatment Only | Other | Device: MOXISubjects 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Healthy male, female, and non-binary adults between 18 and 75 years of age
- Fitzpatrick Skin Phototype V and VI
- Individuals deemed by the Investigator to have clinically significant hyperpigmentation on their face and desire treatment and correction of this condition
- Individuals willing to withhold aesthetic therapies (excluding those explicitly prescribed by the Investigator as pre-treatment) for the duration of the study
- Women of childbearing potential who agree to take a urine pregnancy test at the Screening visit or when deemed by Investigator. Women of childbearing potential must have a negative urine pregnancy test and must not be lactating at Screening. Women must be willing and able to use an acceptable method of birth control (see below) during the study. Women will not be considered of childbearing potential if one or more of the following is documented:
Key exclusion criteria (32 listed)
- Ages < 18 or > 75 years old
- Fitzpatrick Skin Phototypes I-IV
- Known history of allergies or irritant contact dermatitis in response to general skin care products, including Hydroquinone and Retinol
- Known allergies or irritant contact dermatitis in response to common ingredients of physical sunscreen, including but not limited to Zinc Oxide
- Known allergies or irritant contact dermatitis to topical anesthetics, including Benzocaine and Tetracaine.
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 |
|---|---|---|
| MOXIPatients will receive treatment using f1927 devices and will be treated over the affected areas, once each month for a total of three months. | Device | Healthy Participants- Post-Treatment Only, Healthy Participants- Pre-Ttreatment Only |
Primary outcome
Change in Spots - Front of Face (Part 1)
Time frame: Baseline, 1 Month and 3 Months
Quantitively assessment of change in overall spots using measurements provided VISIA 3D analysis of front face Count- the number of individual features detected in the region of interest.
Change in Spots - Front of Face (Part 2)
Time frame: Baseline, 1 Month and 3 Months
Quantitively assessment of change in overall spots using measurements provided VISIA 3D analysis of front face Count- the number of individual features detected in the region of interest.
Change in Spots- Left Side of Face (Part 1)
Time frame: Baseline, 1 Month and 3 Months
Quantitively assessment of change in overall spots using measurements provided VISIA 3D analysis of left side of face Count= the number if individual features detected in the region of interest.
Change in Spots- Left Side of Face (Part 2)
Time frame: Baseline, 1 Month and 3 Months
Quantitively assessment of change in overall spots using measurements provided VISIA 3D analysis of left side of face Count= the number if individual features detected in the region of interest.
Change in Spots- Right Side of Face (Part 1)
Time frame: Baseline, 1 Month and 3 Months
Quantitively assessment of change in overall spots using measurements provided VISIA 3D analysis of right side of face Count= the number if individual features detected in the region of interest.
Change in Spots- Right Side of Face (Part 2)
Time frame: Baseline, 1 Month and 3 Months
Quantitively assessment of change in overall spots using measurements provided VISIA 3D analysis of right side of face Count= the number if individual features detected in the region of interest.
Change in UV Spots- Front of Face (Part 1)
Time frame: Baseline, 1 Month and 3 Months
Quantitively assessment of change in overall UV spots using measurements provided VISIA 3D analysis of front side of face Count= the number if individual features detected in the region of interest.
Change in UV Spots- Front of Face (Part 2)
Time frame: Baseline, 1 Month and 3 Months
Quantitively assessment of change in overall UV spots using measurements provided VISIA 3D analysis of front side of face Count= the number if individual features detected in the region of interest.
Change in UV Spots- Left of Face (Part 1)
Time frame: Baseline, 1 Month and 3 Months
Quantitively assessment of change in overall UV spots using measurements provided VISIA 3D analysis of left side of the face Count= the number if individual features detected in the region of interest.
Change in UV Spots- Left of Face (Part 2)
Time frame: Baseline, 1 Month and 3 Months
Quantitively assessment of change in overall UV spots using measurements provided VISIA 3D analysis of left side of the face Count= the number if individual features detected in the region of interest.
Change in UV Spots- Right Side if Face (Part 1)
Time frame: Baseline, 1 Month and 3 Months
Quantitively assessment of change in overall UV spots using measurements provided VISIA 3D analysis of right side of face Count= the number if individual features detected in the region of interest.
Change in UV Spots- Right Side if Face (Part 2)
Time frame: Baseline, 1 Month and 3 Months
Quantitively assessment of change in overall UV spots using measurements provided VISIA 3D analysis of right side of face Count= the number if individual features detected in the region of interest.
Change in Brown Spots- Front of Face (Part 1)
Time frame: Baseline, 1 Month and 3 Months
Quantitively assessment of change in overall UV spots using measurements provided VISIA 3D analysis of front of face Count= the number if individual features detected in the region of interest.
Change in Brown Spots- Front of Face (Part 2)
Time frame: Baseline, 1 Month and 3 Months
Quantitively assessment of change in overall UV spots using measurements provided VISIA 3D analysis of front of face Count= the number if individual features detected in the region of interest.
Change in Brown Spots- Left of Face (Part 1)
Time frame: Baseline, 1 Month and 3 Months
Quantitively assessment of change in overall UV spots using measurements provided VISIA 3D analysis of left side of face Count= the number if individual features detected in the region of interest.
Change in Brown Spots- Left of Face (Part 2)
Time frame: Baseline, 1 Month and 3 Months
Quantitively assessment of change in overall UV spots using measurements provided VISIA 3D analysis of left side of face Count= the number if individual features detected in the region of interest.
Change in Brown Spots- Right Side of Face (Part 1)
Time frame: Baseline, 1 Month and 3 Months
Quantitively assessment of change in overall UV spots using measurements provided VISIA 3D analysis of right side of face Count= the number if individual features detected in the region of interest.
Change in Brown Spots- Right Side of Face (Part 2)
Time frame: Baseline, 1 Month and 3 Months
Quantitively assessment of change in overall UV spots using measurements provided VISIA 3D analysis of right side of face Count= the number if individual features detected in the region of interest.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Jeffrey Kenkel, MD principal investigator
UT Southwestern- Department of Plastic Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MOXI in people with Hyperpigmentation, run by University of Texas Southwestern Medical Center 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 17 inclusion and 32 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: finished, as of the sponsor's last update on 15 Dec 2025. 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?
Yes. Results are posted in the registry (first posted 14 Nov 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Spots - Front of Face (Part 1) (time frame: Baseline, 1 Month and 3 Months). The study lists 18 primary outcomes in all. 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 15 Dec 2025.