Skin PigmentNCT05226104
Fractionated 1927nm Laser for Diffuse Pigmentation and Actinic Changes.
A study testing MOXI in people with Skin Pigment, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial summary
This is a single-site, non-randomized, non-controlled study at UT Southwestern Medical Center at Dallas in the Department of Plastic Surgery designed to follow up to 30 qualified and consenting subjects receiving a fractionated 1927 combination treatments for diffuse hyperpigmentation and/or melasma. Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Skin Pigment
- What is being tested?
- MOXI
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 18 May 2022to 28 Sep 2022
- 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 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male and female adults between 20-60 years of age.
- Fitzpatrick skin type I-IV.
- Individuals deemed by the Investigator to have a significant amount of pigmentation/melasma and that desire correction of this condition.
- Individuals willing to withhold aesthetic therapies, or other therapies judged to potentially impact results to the treatment areas 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 of the following is documented - postmenopausal for at least 12 months prior to study, without a uterus and/or both ovaries, bilateral tubal ligation at least 6 months prior to study enrollment
- Individuals of childbearing potential who use an acceptable method of contraception throughout the study. Acceptable methods of birth control include:
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- Established use of hormonal contraception (oral, injected, 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.
Who cannot join
- Fitzpatrick skin type V-VI.
- Known allergies to general skin care products.
- Sensitivity to topical lidocaine or ester-based local anesthetics.
- Active systemic or local conditions that may affect wound healing.
- Current or recent history of inflammatory skin disease, infection or unhealed wound in the proposed treatment area(s).
- History of systemic granulomatous diseases, either active or inactive, (e.g. Sarcoid, Wegener's, TB, etc.) or connective tissue diseases (e.g. lupus, dermatomyosistis, etc.).
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- Recent history of significant trauma to the areas to be treated (< 6 months).
- Significant scarring, other than acne scars, in the area(s) to be treated.
- Current or history of hypertrophic scarring or keloid scars.
- Severe or cystic and clinically significant acne on the area(s) to be treated.
- Tattoos in the area to be treated.
- Observable suntan, nevi, excessive hair, etc. or other dermal conditions on the treatment area(s) of the face that might influence study results in the opinion of the Investigator.
- Individuals who currently have cancerous or pre-cancerous lesions in the area(s) to be treated and/or with 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, rejuvenative 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.
- History of using the following prescription medications:
- Accutane or other systemic retinoids within the past 6 months
- Topical retinoids within the past 4 weeks
- Prescription strength lightening devices (e.g. hydroquinone, tretinoin, AHA, BHA, poly-hydroxy acids, 4-hydroxyanisole alone or combined with tretinoin, etc.) within 4 months
- Any anti-wrinkle or skin lightening devices, or topical or systemic medication known to affect skin aging or dyschromia (e.g. devices containing alpha/beta/polyhydroxy acids, Vitamin C, soy, Q-10, hydroquinone, systemic or licorice extract (topically), Tego ®, Cosmo C250, gigawhite, lemon juice extract (topically), embilica extract, etc.) within 2 weeks
- 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 course of 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 Department of Plastic Surgery
Dallas, Texas, 75390
About this study
Official title: Investigating the Efficacy of a Fractionated 1927nm Laser for Diffuse Pigmentation and Actinic Changes
This is a single-site, non-randomized, non-controlled study at UT Southwestern Medical Center at Dallas in the Department of Plastic Surgery designed to follow up to 30 qualified and consenting subjects receiving a fractionated 1927 combination treatments for diffuse hyperpigmentation and/or melasma. Patients will receive treatment using f1927 devices and will be treated twice over the affected areas, once each month for a total of two months, followed by two follow-up visits at 1-month and 3-months post-treatment.
Read the detailed description
This is a prospective, non-controlled study where subjects will receive treatment using f1927 devices and will be treated twice over the affected areas of the face once each month for a total of two months. Patients will be evaluated at 1-month and 3-months post-treatment to monitor the clinical effects of treatment. Overall assessment of treatment efficacy will be based on evaluation of standard and close-up photography using pre- and post-procedural photos as well as images obtained by the Vectra H2 3D Imaging System. Baseline changes in the visualization and numeric analysis of pigmented areas will be evaluated utilizing the 3D Facial Skin Analysis software on the H2 System. Subjects will also undergo non-invasive skin measurements using optical coherence tomography (OCT) to noninvasively gather topographical and histological images of pre- and post-treated skin. Screening, treatment(s) with f1927, and OCT measurements are all for research purposes.
- Conditions
- Skin Pigment
- Being tested
- MOXI
- Medical subject headings
- Pigmentation Disorders
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 twice over the affected areas, once each month for a total of two months.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Participants | Other | Subjects who are interested in treatment for facial fine lines and wrinkles will be recruited for the study. Receives: Device: MOXI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Dyspigmentation Spots
Numeric analysis of dyspigmentation (spots) will be analyzed using VISIA System.
The change from baseline was calculated at Month 1 and Month 3. An increase in the absolute count would indicate improvement.
Measured: Baseline, Month 1 and Month 3
Change in UV Spots
Numeric analysis of lesions resulting from photodamage will be analyzed using VISIA System.
The change from baseline was calculated at Month 1 and Month 3. An increase in the absolute count would indicate improvement.
Measured: Baseline, Month 1 and Month 3
Change in Brown Spots
Numeric analysis of lentigines and melasma will be analyzed using the VISIA system.
The change from baseline was calculated at Month 1 and Month 3. An increase in the absolute count would indicate improvement.
Measured: Baseline, Month 1 and Month 3
Physician's Global Assessment Scores (PGAS)- Right Face
Clinician evaluators assessed the right side of each participants 1 and 3 month photographs to subjectively score clinical improvement.
PGAS Score Description 0 Clear, except for possible residual discoloration, 100% improvement.
- Almost clear, very significant clearance, 90% improvement; only minor evidence of hyperpigmentation remains.
- Marked improvement, significant improvement, 75% improvement. Some disease evidence of hyperpigmentation remains.
- Moderate improvement, intermediate between slight and marked improvement; 50% improvement in appearance of hyperpigmentation
- Slight improvement, some improvement, 25% improvement; significant evidence of hyperpigmentation remains
- No improvement; hyperpigmented condition unchanged
- Worse; condition worse than at week 0
Measured: Month 1 and Month 3
Physician's Global Assessment Scores (PGAS)- Left Face
Clinician evaluators assessed the left side of each participants 1 and 3 month photographs to subjectively score clinical improvement.
PGAS Score Description 0 Clear, except for possible residual discoloration, 100% improvement.
- Almost clear, very significant clearance, 90% improvement; only minor evidence of hyperpigmentation remains.
- Marked improvement, significant improvement, 75% improvement. Some disease evidence of hyperpigmentation remains.
- Moderate improvement, intermediate between slight and marked improvement; 50% improvement in appearance of hyperpigmentation
- Slight improvement, some improvement, 25% improvement; significant evidence of hyperpigmentation remains
- No improvement; hyperpigmented condition unchanged
- Worse; condition worse than at week 0
Measured: Month 1 and Month 3
Physician's Global Assessment Score (PGAS)- Overall
Clinician evaluators assessed 1 and 3 month photographs to subjectively score clinical overall improvement.
PGAS Score Description 0 Clear, except for possible residual discoloration, 100% improvement.
- Almost clear, very significant clearance, 90% improvement; only minor evidence of hyperpigmentation remains.
- Marked improvement, significant improvement, 75% improvement. Some disease evidence of hyperpigmentation remains.
- Moderate improvement, intermediate between slight and marked improvement; 50% improvement in appearance of hyperpigmentation
- Slight improvement, some improvement, 25% improvement; significant evidence of hyperpigmentation remains
- No improvement; hyperpigmented condition unchanged
- Worse; condition worse than at week 0
Measured: Month 1 and Month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2022
- Study start18 May 2022
- Primary completion28 Sep 2022
- Study completion28 Sep 2022
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 Skin PigmentStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abby Culver, University of Texas Southwestern Medical Center
- Investigators
- Abby Culver, MD, Principal investigator, UT SouthwesternJeffrey Kenkel, MD, Principal investigator, UT Southwestern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05226104
- Sponsor's protocol ID
- STU-2021-1191
- Status last verified
- Jul 2023
- First submitted
- 10 Jan 2022
- Last updated
- 21 Aug 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Efficacy of a Fractionated 1927nm Laser for Diffuse Pigmentation and Actinic Changes
- ClinicalTrials.gov ID
- NCT05226104
- Acronym / sponsor ID
- STU-2021-1191
- Conditions
- Skin Pigment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- 18 May 2022 (actual)
- Primary completion
- 28 Sep 2022 (actual)
- Study completion
- 28 Sep 2022 (actual)
- First posted
- 7 Feb 2022 (actual)
- Results
- Posted 21 Aug 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a single-site, non-randomized, non-controlled study at UT Southwestern Medical Center at Dallas in the Department of Plastic Surgery designed to follow up to 30 qualified and consenting subjects receiving a fractionated 1927 combination treatments for diffuse hyperpigmentation and/or melasma. Patients will receive treatment using f1927 devices and will be treated twice over the affected areas, once each month for a total of two months, followed by two follow-up visits at 1-month and 3-months post-treatment.
Detailed description
This is a prospective, non-controlled study where subjects will receive treatment using f1927 devices and will be treated twice over the affected areas of the face once each month for a total of two months. Patients will be evaluated at 1-month and 3-months post-treatment to monitor the clinical effects of treatment. Overall assessment of treatment efficacy will be based on evaluation of standard and close-up photography using pre- and post-procedural photos as well as images obtained by the Vectra H2 3D Imaging System. Baseline changes in the visualization and numeric analysis of pigmented areas will be evaluated utilizing the 3D Facial Skin Analysis software on the H2 System. Subjects will also undergo non-invasive skin measurements using optical coherence tomography (OCT) to noninvasively gather topographical and histological images of pre- and post-treated skin. Screening, treatment(s) with f1927, and OCT measurements are all for research purposes.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy Participants | Other | Device: MOXISubjects who are interested in treatment for facial fine lines and wrinkles will be recruited for the study. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- Healthy male and female adults between 20-60 years of age.
- Fitzpatrick skin type I-IV.
- Individuals deemed by the Investigator to have a significant amount of pigmentation/melasma and that desire correction of this condition.
- Individuals willing to withhold aesthetic therapies, or other therapies judged to potentially impact results to the treatment areas 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 of the following is documented - postmenopausal for at least 12 months prior to study, without a uterus and/or both ovaries, bilateral tubal ligation at least 6 months prior to study enrollment
Key exclusion criteria (37 listed)
- Fitzpatrick skin type V-VI.
- Known allergies to general skin care products.
- Sensitivity to topical lidocaine or ester-based local anesthetics.
- Active systemic or local conditions that may affect wound healing.
- Current or recent history of inflammatory skin disease, infection or unhealed wound in the proposed treatment area(s).
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 twice over the affected areas, once each month for a total of two months. | Device | Healthy Participants |
Primary outcome
Change in Dyspigmentation Spots
Time frame: Baseline, Month 1 and Month 3
Numeric analysis of dyspigmentation (spots) will be analyzed using VISIA System. The change from baseline was calculated at Month 1 and Month 3. An increase in the absolute count would indicate improvement.
Change in UV Spots
Time frame: Baseline, Month 1 and Month 3
Numeric analysis of lesions resulting from photodamage will be analyzed using VISIA System. The change from baseline was calculated at Month 1 and Month 3. An increase in the absolute count would indicate improvement.
Change in Brown Spots
Time frame: Baseline, Month 1 and Month 3
Numeric analysis of lentigines and melasma will be analyzed using the VISIA system. The change from baseline was calculated at Month 1 and Month 3. An increase in the absolute count would indicate improvement.
Physician's Global Assessment Scores (PGAS)- Right Face
Time frame: Month 1 and Month 3
Clinician evaluators assessed the right side of each participants 1 and 3 month photographs to subjectively score clinical improvement. PGAS Score Description 0 Clear, except for possible residual discoloration, 100% improvement. 1. Almost clear, very significant clearance, 90% improvement; only minor evidence of hyperpigmentation remains. 2. Marked improvement, significant improvement, 75% improvement. Some disease evidence of hyperpigmentation remains. 3. Moderate improvement, intermediate between slight and marked improvement; 50% improvement in appearance of hyperpigmentation 4. Slight improvement, some improvement, 25% improvement; significant evidence of hyperpigmentation remains 5. No improvement; hyperpigmented condition unchanged 6. Worse; condition worse than at week 0
Physician's Global Assessment Scores (PGAS)- Left Face
Time frame: Month 1 and Month 3
Clinician evaluators assessed the left side of each participants 1 and 3 month photographs to subjectively score clinical improvement. PGAS Score Description 0 Clear, except for possible residual discoloration, 100% improvement. 1. Almost clear, very significant clearance, 90% improvement; only minor evidence of hyperpigmentation remains. 2. Marked improvement, significant improvement, 75% improvement. Some disease evidence of hyperpigmentation remains. 3. Moderate improvement, intermediate between slight and marked improvement; 50% improvement in appearance of hyperpigmentation 4. Slight improvement, some improvement, 25% improvement; significant evidence of hyperpigmentation remains 5. No improvement; hyperpigmented condition unchanged 6. Worse; condition worse than at week 0
Physician's Global Assessment Score (PGAS)- Overall
Time frame: Month 1 and Month 3
Clinician evaluators assessed 1 and 3 month photographs to subjectively score clinical overall improvement. PGAS Score Description 0 Clear, except for possible residual discoloration, 100% improvement. 1. Almost clear, very significant clearance, 90% improvement; only minor evidence of hyperpigmentation remains. 2. Marked improvement, significant improvement, 75% improvement. Some disease evidence of hyperpigmentation remains. 3. Moderate improvement, intermediate between slight and marked improvement; 50% improvement in appearance of hyperpigmentation 4. Slight improvement, some improvement, 25% improvement; significant evidence of hyperpigmentation remains 5. No improvement; hyperpigmented condition unchanged 6. Worse; condition worse than at week 0
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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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.
Abby Culver, MD principal investigator
UT Southwestern
Jeffrey Kenkel, MD principal investigator
UT Southwestern
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 Skin Pigment, 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 14 inclusion and 37 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 21 Aug 2023. 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 21 Aug 2023). 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 Dyspigmentation Spots (time frame: Baseline, Month 1 and Month 3). The study lists 6 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 21 Aug 2023.