VitiligoEarly Phase 1NCT04738149
Effect of Microneedling, Bimatoprost and Excimer in Vitiligo Treatment
A Early Phase 1 study testing Bimatoprost, Excimer laser and Microneedling with a dermaroller in people with Vitiligo, run by Medical University of South Carolina at 1 site in United States.
Trial summary
The purpose of this research is to treat vitiligo with a topical PGF2α, microneedling and excimer laser. The goal is to have greater repigmentation than the standard of care (excimer) after 12 weeks of treatment. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Vitiligo
- What is being tested?
- Bimatoprost, Excimer laser and Microneedling with a dermaroller
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Nov 2021to 15 May 2022
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All patients 18 years and older with the diagnosis of Vitiligo.
Who cannot join
- Female patients currently pregnant or lactating
- Female patients with plans to come pregnant during the next 3 months
- Allergic reactions to topical or oral prostaglandins
- Uncontrolled skin disease
- History of glaucoma
- Concomitant disease or therapy that interferes with the diagnosis that might interfere with vitiligo diagnosis sand evaluation.
- Patients currently using other treatments for Vitiligo, such as topical steroids, calcineurin inhibitors, and Vitamin D analogs within 2 weeks of study initiation
- Inability or unwillingness of subject or legal guardian/representative to give
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical University of South Carolina
Charleston, South Carolina, 29407
About this study
Official title: A Proof of Concept, Split Study Measuring the Effectiveness of Topical ProstaglandinF2alpha, Microneedling and Excimer Laser in the Treatment of Vitiligo
The purpose of this research is to treat vitiligo with a topical PGF2α, microneedling and excimer laser. The goal is to have greater repigmentation than the standard of care (excimer) after 12 weeks of treatment.
The study is a pilot, split study meaning the patient will receive one experimental and one standard of care treatment on symmetric lesions of similar location, geometrics and size.
Read more
Enrolled subjects will present biweekly to clinic on the same two days for twelve weeks. One lesion will be treated with microneedling, topical PGF2α and calibrated excimer laser, while the parallel lesion will be excimer laser alone. Physical exam, photographs, and a review of of the subjects medical records will occur in the study. Changes in size, appearance, and adverse events will be monitored throughout the study. The patient will also agree to close up photographs of their lesions throughout the study.
The possible benefit of joining this study is that the treatment received may be more effective than the other study treatment or then other available treatments for vitiligo, although this cannot be guaranteed.
- Conditions
- Vitiligo
- Being tested
- Bimatoprost, Excimer laser, Microneedling with a dermaroller
- Medical subject headings
- Vitiligo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BimatoprostDrug
Participants will be receiving 2 drops per 4cm2 twice a week for 12 weeks
Excimer laserDevice
Participants will be receiving excimer laser 2x a week for 12 weeks
Microneedling with a dermarollerDevice
Participants will have 4cm2 area pre-treated with dermaroller 2x per week for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Area 1: Excimer laser, bimatoprost, and microneedling | Experimental | Not described Receives: Drug: Bimatoprost; Device: Excimer laser; Device: Microneedling with a dermaroller |
| Area 2: Excimer laser | Active comparator | Not described Receives: Device: Excimer laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of skin repigmentation after 12 weeks
A blinded outcome accessor will compare photographs of patients before and after treatment.
Measured: Post treatment (at week 12)
Number of patients with perceived improvement after 12 weeks.
Patients will be completing the Vitiligo Noticeability Scale that encompasses a series of questions assessing patient perceived change of before and after photographs.
Measured: Week 12
Secondary outcomes (2)
Change in quality of life
To access vitiligo patient specifically though a QOL reliable and valid scale.
Measured: Baseline and post treatment approximately 12 weeks
Change in quality of life
To access quality of life via a validated general Dermatology Life Quality Index Scale.
Measured: Baseline and post treatment approximately 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2021
- Study start2 Nov 2021
- Primary completion15 May 2022
- Study completion15 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VitiligoStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joni Mazza Mccrann, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04738149
- Sponsor's protocol ID
- 00104695
- Status last verified
- Aug 2022
- First submitted
- 22 Jan 2021
- Last updated
- 5 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Proof of Concept, Split Study Measuring the Effectiveness of Topical ProstaglandinF2alpha, Microneedling and Excimer Laser in the Treatment of Vitiligo
- ClinicalTrials.gov ID
- NCT04738149
- Acronym / sponsor ID
- 00104695
- Conditions
- Vitiligo
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Study start
- 2 Nov 2021 (actual)
- Primary completion
- 15 May 2022 (actual)
- Study completion
- 15 May 2022 (actual)
- First posted
- 4 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research is to treat vitiligo with a topical PGF2α, microneedling and excimer laser. The goal is to have greater repigmentation than the standard of care (excimer) after 12 weeks of treatment.
The study is a pilot, split study meaning the patient will receive one experimental and one standard of care treatment on symmetric lesions of similar location, geometrics and size.
Enrolled subjects will present biweekly to clinic on the same two days for twelve weeks. One lesion will be treated with microneedling, topical PGF2α and calibrated excimer laser, while the parallel lesion will be excimer laser alone. Physical exam, photographs, and a review of of the subjects medical records will occur in the study. Changes in size, appearance, and adverse events will be monitored throughout the study. The patient will also agree to close up photographs of their lesions throughout the study.
The possible benefit of joining this study is that the treatment received may be more effective than the other study treatment or then other available treatments for vitiligo, although this cannot be guaranteed.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Area 1: Excimer laser, bimatoprost, and microneedling | Experimental | Drug: Bimatoprost, Device: Excimer laser, Device: Microneedling with a dermaroller |
| Area 2: Excimer laser | Active comparator | Device: Excimer laser |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients 18 years and older with the diagnosis of Vitiligo.
Key exclusion criteria (8 listed)
- Female patients currently pregnant or lactating
- Female patients with plans to come pregnant during the next 3 months
- Allergic reactions to topical or oral prostaglandins
- Uncontrolled skin disease
- History of glaucoma
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 |
|---|---|---|
| BimatoprostParticipants will be receiving 2 drops per 4cm2 twice a week for 12 weeks | Drug | Area 1: Excimer laser, bimatoprost, and microneedling |
| Excimer laserParticipants will be receiving excimer laser 2x a week for 12 weeks | Device | Area 1: Excimer laser, bimatoprost, and microneedling, Area 2: Excimer laser |
| Microneedling with a dermarollerParticipants will have 4cm2 area pre-treated with dermaroller 2x per week for 12 weeks | Device | Area 1: Excimer laser, bimatoprost, and microneedling |
Primary outcome
Percentage of skin repigmentation after 12 weeks
Time frame: Post treatment (at week 12)
A blinded outcome accessor will compare photographs of patients before and after treatment.
Number of patients with perceived improvement after 12 weeks.
Time frame: Week 12
Patients will be completing the Vitiligo Noticeability Scale that encompasses a series of questions assessing patient perceived change of before and after photographs.
2 secondary outcomes
Change in quality of life
Time frame: Baseline and post treatment approximately 12 weeks
Change in quality of life
Time frame: Baseline and post treatment approximately 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2022.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Bimatoprost, Excimer laser and Microneedling with a dermaroller in people with Vitiligo, run by Medical University of South Carolina 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 1 inclusion and 8 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 5 Aug 2022. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Percentage of skin repigmentation after 12 weeks (time frame: Post treatment (at week 12)). The study lists 2 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 5 Aug 2022.