VitiligoNCT05053022
A Study to Evaluate the Efficacy of Microneedling as a Stand-alone Treatment for Vitiligo
A study testing Skinpen Precision System in people with Vitiligo, run by Crown Laboratories, Inc. at 1 site in United States.
Trial summary
This is a study that is being conducted in order to assess the efficacy of microneedling as a stand-alone treatment for vitiligo. Vitiligo is an autoimmune depigmentation disease of the skin that is characterized by the destruction of epidermal melanocytes by CD8+ T cells. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Vitiligo
- What is being tested?
- Skinpen Precision System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Jul 2021to 24 Jan 2023
- Phase
- Interventional
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adult male or female, ages 18 through 60.
- Clinical diagnosis of stable Vitiligo (no changes within the past 6 months) on any of the following body areas: face, neck, trunk, extremities, hands, feet (excluding digits).
- Subjects in generally good health and free of any conditions which, in the opinion of the investigator, would interfere with the study assessments.
- Subjects willing to discontinue all current therapies for vitiligo for the duration of the study.
- Women of childbearing potential agree to take a urine pregnancy test at the Baseline visit and Final visit.
- Individuals that are willing to provide written informed consent and are able to read, speak, write and understand the informed consent document.
- Willingness to cooperate and participate by following study requirements for the duration of the study and to report any changes in health status or medications, adverse event symptoms, or reactions immediately.
Who cannot join
- Individuals diagnosed with known allergies to facial or general skin care products.
- Individuals who have presence of an active systemic or local skin disease, apart from vitiligo, that may affect wound healing. Uncontrolled disease such as asthma, diabetes, hyperthyroidism, medically significant hypertension or hypothyroidism. Individuals having multiple health conditions may be excluded from participation even if the conditions are controlled by diet, medication, etc.
- Individuals with sensitivity to topical lidocaine, stainless steel, nickel, or chromium
- Individuals who have a recent or current history of inflammatory skin disease or cancerous/pre-cancerous lesion.
- Subjects currently or within the past 3 months on Vitiligo topical or systemic treatments.
- Use of skin lighteners or bleaching agents; hydroquinone, phenol peels or harsh chemicals.
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- Individuals who have the inability to understand instructions or to give informed consent.
- Individuals who have a history of chronic drug or alcohol abuse.
- Individuals undergoing concurrent therapy that, in the Investigator's opinion, would interfere with the evaluation of the safety or efficacy of the study device.
- Individuals who are current smokers.
- Individuals who are nursing, pregnant, or planning to become pregnant during the study according to subject self-report.
- Individuals with a history of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or currently using immunosuppressive medications (e.g., azathioprine, belimumab, cyclophosphamide, Enbrel, Imuran, Humira, mycophenolate mofetil, methotrexate, prednisone, Remicade, Stelara.) and/or radiation as determined by study documentation.
- Individuals with any planned surgeries, overnight hospitalization, and/or invasive medical procedures during the course of the study.
- Individuals who are currently participating in any other study involving the use of investigational device or drugs at another research facility or doctor's office within 4 weeks prior to inclusion into the study.
- Individuals who have any condition, which in the opinion of the Investigator makes the patient unable to complete the study per protocol (e.g. patients not likely to avoid other facial cosmetic treatments; patients not likely to stay in the study for its duration because of other commitments, concomitant conditions, or past history; patients anticipated to be unreliable, or patients who have a concomitant condition that may develop symptoms that might confuse or confound study treatments or assessments)
Trial locations and contacts
1 site in 1 country.
About this study
This is a study that is being conducted in order to assess the efficacy of microneedling as a stand-alone treatment for vitiligo. Vitiligo is an autoimmune depigmentation disease of the skin that is characterized by the destruction of epidermal melanocytes by CD8+ T cells. The pathogenesis of Vitiligo has been linked to autoimmunity, oxidative stress, and genetic susceptibility.
Read the detailed description
Microneedling is a minimally invasive technique developed for skin rejuvenation. In the treatment for vitiligo, the procedure causes micro-inflammations on the epidermis and enhances melanocytes and keratinocytes migration. This process leads to the stimulation and repigmentation of vitiligo areas. Several topical therapies such as Tacrolimus and 5-Fluorouracilused in conjunction with microneedling have yielded favorable repigmentation results. This study aims to evaluate the repigmentation rates of microneedled vitiligo patches without any topical medications other than sunscreen.
There will be a total of 8 -12 treatments over the course of 244 days, with subjects receiving a treatment every 2 weeks.
- Conditions
- Vitiligo
- Being tested
- Skinpen Precision System
- Medical subject headings
- Vitiligo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Skinpen Precision SystemDevice
Subjects will receive a total of 8-12 treatments with the Skinpen Precision system targeting their Vitiligo lesions.
| Study group | Role | What they receive |
|---|---|---|
| Microneedling with Skinpen Precision System | Experimental | Skinpen precision system will be used in accordance with the instructions in the IFU on the treatment area. A numbing cream will be applied at least 20-30 minutes before the Skinpen Precision system treatment is done. The affected areas will be treated at depths of up to 2.50mm. Treatment depth will be recorded for each treatment at every visit.
Subjects will be dispensed with the Blue Lizard sunscreen and trained on proper use. Receives: Device: Skinpen Precision System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physician's Global Assessment (PGA)
PGA to be completed starting at Visit 2 and on, prior to each treatment. The primary endpoint is to achieve Grade 2, 3 or 4 on the PGA Scale comparing photographs from baseline to visits 12, 13, and 14.
This is a 5 Grade Repigmentation Scale. This assessment uses a scale of G0-G4. This global assessment will be done by the investigator starting at Visit 2 and afterwards.
G4 Excellent > 75% Repigmentation G3 Very Good 50%-75% Repigmentation G2 Good 25%-50% Repigmentation G1 Satisfactory <25% Repigmentation G0 Poor No Repigmentation
Measured: Through Study Completion, over the course of 244 days
Secondary outcomes (1)
Subject's assessment of their pre and post-treatment images using the Vitiligo Noticeability Scale (VNS)
Subject's assessment of their pre and post-treatment images using the Vitiligo Noticeability Scale. A score of 3,4, or 5 indicates the success of the treatment.
Measured: Through Study Completion, over the course of 244 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2021
- Study start29 Jul 2021
- Primary completion21 Nov 2022
- Study completion24 Jan 2023
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.
- 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
- Model description
- A proof of concept study to determine the safety and efficacy of Microneedling in patients with stable Vitiligo.
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Crown Laboratories, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05053022
- Sponsor's protocol ID
- CL-VL-21-04
- Status last verified
- May 2023
- First submitted
- 26 Aug 2021
- Last updated
- 24 May 2023
- Results posted
- No
- 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 24 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate the Efficacy of Microneedling as a Stand-alone Treatment for Vitiligo
- ClinicalTrials.gov ID
- NCT05053022
- Acronym / sponsor ID
- CL-VL-21-04
- Conditions
- Vitiligo
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Crown Laboratories, Inc.Industry (pharma, biotech, devices)
- Study start
- 29 Jul 2021 (actual)
- Primary completion
- 21 Nov 2022 (actual)
- Study completion
- 24 Jan 2023 (actual)
- First posted
- 22 Sep 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.
This is a study that is being conducted in order to assess the efficacy of microneedling as a stand-alone treatment for vitiligo. Vitiligo is an autoimmune depigmentation disease of the skin that is characterized by the destruction of epidermal melanocytes by CD8+ T cells. The pathogenesis of Vitiligo has been linked to autoimmunity, oxidative stress, and genetic susceptibility.
Detailed description
Microneedling is a minimally invasive technique developed for skin rejuvenation. In the treatment for vitiligo, the procedure causes micro-inflammations on the epidermis and enhances melanocytes and keratinocytes migration. This process leads to the stimulation and repigmentation of vitiligo areas. Several topical therapies such as Tacrolimus and 5-Fluorouracilused in conjunction with microneedling have yielded favorable repigmentation results. This study aims to evaluate the repigmentation rates of microneedled vitiligo patches without any topical medications other than sunscreen.
There will be a total of 8 -12 treatments over the course of 244 days, with subjects receiving a treatment every 2 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A proof of concept study to determine the safety and efficacy of Microneedling in patients with stable Vitiligo.
| Arm | Type | Receives |
|---|---|---|
| Microneedling with Skinpen Precision System | Experimental | Device: Skinpen Precision SystemSkinpen precision system will be used in accordance with the instructions in the IFU on the treatment area. A numbing cream will be applied at least 20-30 minutes before the Skinpen Precision system treatment is done. The affected areas will be treated at depths of up to 2.50mm. Treatment depth will be recorded for each treatment at every visit. Subjects will be dispensed with the Blue Lizard sunscreen and trained on proper use. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Adult male or female, ages 18 through 60.
- Clinical diagnosis of stable Vitiligo (no changes within the past 6 months) on any of the following body areas: face, neck, trunk, extremities, hands, feet (excluding digits).
- Subjects in generally good health and free of any conditions which, in the opinion of the investigator, would interfere with the study assessments.
- Subjects willing to discontinue all current therapies for vitiligo for the duration of the study.
- Women of childbearing potential agree to take a urine pregnancy test at the Baseline visit and Final visit.
Key exclusion criteria (15 listed)
- Individuals diagnosed with known allergies to facial or general skin care products.
- Individuals who have presence of an active systemic or local skin disease, apart from vitiligo, that may affect wound healing. Uncontrolled disease such as asthma, diabetes, hyperthyroidism, medically significant hypertension or hypothyroidism. Individuals having multiple health conditions may be excluded from participation even if the conditions are controlled by diet, medication, etc.
- Individuals with sensitivity to topical lidocaine, stainless steel, nickel, or chromium
- Individuals who have a recent or current history of inflammatory skin disease or cancerous/pre-cancerous lesion.
- Subjects currently or within the past 3 months on Vitiligo topical or systemic treatments.
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 |
|---|---|---|
| Skinpen Precision SystemSubjects will receive a total of 8-12 treatments with the Skinpen Precision system targeting their Vitiligo lesions. | Device | Microneedling with Skinpen Precision System |
Primary outcome
Physician's Global Assessment (PGA)
Time frame: Through Study Completion, over the course of 244 days
PGA to be completed starting at Visit 2 and on, prior to each treatment. The primary endpoint is to achieve Grade 2, 3 or 4 on the PGA Scale comparing photographs from baseline to visits 12, 13, and 14. This is a 5 Grade Repigmentation Scale. This assessment uses a scale of G0-G4. This global assessment will be done by the investigator starting at Visit 2 and afterwards. G4 Excellent > 75% Repigmentation G3 Very Good 50%-75% Repigmentation G2 Good 25%-50% Repigmentation G1 Satisfactory <25% Repigmentation G0 Poor No Repigmentation
1 secondary outcome
Subject's assessment of their pre and post-treatment images using the Vitiligo Noticeability Scale (VNS)
Time frame: Through Study Completion, over the course of 244 days
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 24 May 2023.
- 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 study testing Skinpen Precision System in people with Vitiligo, run by Crown Laboratories, Inc. 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 7 inclusion and 15 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 24 May 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?
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?
Physician's Global Assessment (PGA) (time frame: Through Study Completion, over the course of 244 days). 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 24 May 2023.