VitiligoNCT05233735
Enhanced Transcutaneous Delivery of Betamethasone for the Treatment of Vitiligo
A study testing Enhanced Transcutaneous Delivery of Topical Betamethasone after the treatment with Tixel and Topical treatment in people with Vitiligo, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
Trial summary
Vitiligo is the commonest acquired depigmenting disorder characterized by loss of melanocytes from the basal layer of skin causing white patches which leads to great psychological distress in many patients. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Vitiligo
- What is being tested?
- Enhanced Transcutaneous Delivery of Topical Betamethasone after the treatment with Tixel and Topical treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Jan 2021to 31 Dec 2024
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Symmetric vitiligo
- Stable vitiligo for at least six months (< 10% change in the last 6 months)
- Diagnosis was made clinically by a dermatologist
- Age over 18 -70 years men and women
Who cannot join
- Non Stable vitiligo
- Contraindications for phototherapy
- Pregnancy or lactation
- Lack of willingness to go to phototherapy 3 times a week for at least 6 months
- Segmental Vitiligo
- Phototherapy or topical therapy for vitiligo in the last 1 month.
Show all 9Show fewer
- Exit criteria:
- Intolerable to the the study treatment
- Lack of patient's compliance
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Department of Dermatology, Tel Aviv Sourasky medical center
Tel Aviv, 64239
Mor Pavlovski, MD, 972527360388, Mashapavl@gmail.com
About this study
Official title: An Enhanced Transcutaneous Delivery of Topical Betamethasone for the Treatment of Vitiligo Disease
Vitiligo is the commonest acquired depigmenting disorder characterized by loss of melanocytes from the basal layer of skin causing white patches which leads to great psychological distress in many patients. Even though the pathogenic mechanisms of the loss of melanocytes are well researched, a permanent cure for the disease is still elusive. The key principle in the management of vitiligo is to attain stability and to induce active residual melanocytes to repopulate within the depigmented patch thus resulting in repigmentation. In recent years the use of various devices for enhanced transcutaneous delivery of various topical preparations has become more and more common in Dermatology. The aim of this study is to see whether using the Tixel device to enhance the penetration of topical betamethasone can improve the effectiveness of the treatment of pigment regeneration in vitiligo.
Read the detailed description
Vitiligo is a psychologically devastating disorder. The fact that it typically occurs in exposed areas (the face and hands) has a major impact on self-esteem and perception of self. While lesions are usually asymptomatic, the psychosocial impact on patients can be tremendous.
Currently available medical therapies for vitiligo are unsatisfactory and there is no FDA approved drug for the treatment of vitiligo. The perfect medication for this disease would be a topically applied formulation that can rapidly restore pigmentation without systemic absorption or cutaneous side effects.
Tixel is a novel non-laser thermo-mechanical system (Tixel, Novoxel, and Israel), that is, a registered medical device in several countries worldwide. The mechanism of action is by evaporation and thermal decomposition of stratum corneum and the dehydration of epidermis.
The aim of our study is to evaluate the clinical effectiveness and safety profile of a novel approach using an energy-based device (Tixel, Novoxel, and Israel), followed by the topical application of Bethametasone for the treatment of vitiligo.
- Conditions
- Vitiligo
- Being tested
- Enhanced Transcutaneous Delivery of Topical Betamethasone after the treatment with Tixel, Topical treatment
- Keywords
- Vitiligo, Tixel, Enhanced Transcutaneous Delivery
- Medical subject headings
- Vitiligo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhanced Transcutaneous Delivery of Topical Betamethasone after the treatment with TixelOther
Tixel Parameters: exposure time 6-8 milliseconds, 400-600 μm protrusion
Topical treatmentOther
betamethasone ointment treatment once per day
| Study group | Role | What they receive |
|---|---|---|
| topical treatment | Other | Topical Betamethasone for the Treatment of Vitiligo Disease Receives: Other: Topical treatment |
| Enhanced Transcutaneous Delivery | Experimental | Enhanced Transcutaneous Delivery of Topical Betamethasone after a treatment with Tixel device for the Treatment of Vitiligo Disease Receives: Other: Enhanced Transcutaneous Delivery of Topical Betamethasone after the treatment with Tixel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient's global impression of change (PGIC) scale
The self-report measure Patient Global Impression of Change (PGIC) reflects a patient's belief about the efficacy of treatment. Although widely used in chronic pain clinical trials, PGIC's validity has not been formally assessed. PGIC is a 7 point scale depicting a patient's rating of overall improvement. Patients rate their change as "1- very much improved," "2- much improved," "3- minimally improved," "4-no change," "5- minimally worse," "6- much worse," or "7- very much worse."
Measured: up to 2 years
Dermatology life quality index (DLQI)
The Dermatology life Quality Index (DLQI) is a ten-question questionnaire used to measure the impact of skin disease on the quality of life of an affected person.
There are 10 questions, covering the following topics: symptoms, embarrassment, shopping and home care, clothes, social and leisure, sport, work or study, close relationships, sex, treatment. Each question refers to the impact of the skin disease on the patient's life over the previous week Each question is scored from 0 to 3, giving a possible score range from 0 (meaning no impact of skin disease on quality of life) to 30 (meaning maximum impact on quality of life).
A series of validated "band descriptors" were described in 2005 to give meaning to the scores of the DLQI.
These bands are as follows: 0-1 = No effect on patient's life, 2-5 = Small effect, 6-10 = Moderate effect, 11-20 = Very large effect, 21-30 = Extremely large effect.
Measured: up to 2 years
Physician's global assessment (PGA) scale
0-4 scale of improvement 0- Absent: 0%
- Minimal: < 25%
- Mild: 26-50%
- Moderate: 51-75% 4 -Marked to complete: > 75%.
Measured: up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2022
- Study start1 Jan 2021
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2024 (estimated)
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 Tel-Aviv Sourasky 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
- Parallel groups
- Model description
- Recruited patients will have at least 3 × 3 cm patches in greatest dimensions in symmetrical locations for example both forearms, both legs ect. one side will serve as target lesion and the other willl rec. Patients receiving topical or systemic therapy for vitiligo will be kept off treatment for 4 weeks prior to start of therapy. each patient will have 2 different treatments. one side - topical application of Betamethasone alone other side - enhanced Transcutaneous Delivery of Topical Betamethasone for the Treatment after treatment with Tixel. each patient will be treated with the 2 modes of treatments - 2 arms in symmetrical locations
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Eli Sprecher, MD, Tel-Aviv Sourasky Medical Center
- Investigators
- Mor Pavlovski, MD, Principal investigator, Sourasky Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05233735
- Sponsor's protocol ID
- 0853-20
- Status last verified
- Feb 2022
- First submitted
- 5 Oct 2021
- Last updated
- 10 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Enhanced Transcutaneous Delivery of Topical Betamethasone for the Treatment of Vitiligo Disease
- ClinicalTrials.gov ID
- NCT05233735
- Acronym / sponsor ID
- 0853-20
- Conditions
- Vitiligo
- Keywords
- Vitiligo, Tixel, Enhanced Transcutaneous Delivery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 10 Feb 2022 (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.
Vitiligo is the commonest acquired depigmenting disorder characterized by loss of melanocytes from the basal layer of skin causing white patches which leads to great psychological distress in many patients. Even though the pathogenic mechanisms of the loss of melanocytes are well researched, a permanent cure for the disease is still elusive. The key principle in the management of vitiligo is to attain stability and to induce active residual melanocytes to repopulate within the depigmented patch thus resulting in repigmentation. In recent years the use of various devices for enhanced transcutaneous delivery of various topical preparations has become more and more common in Dermatology. The aim of this study is to see whether using the Tixel device to enhance the penetration of topical betamethasone can improve the effectiveness of the treatment of pigment regeneration in vitiligo.
Detailed description
Vitiligo is a psychologically devastating disorder. The fact that it typically occurs in exposed areas (the face and hands) has a major impact on self-esteem and perception of self. While lesions are usually asymptomatic, the psychosocial impact on patients can be tremendous.
Currently available medical therapies for vitiligo are unsatisfactory and there is no FDA approved drug for the treatment of vitiligo. The perfect medication for this disease would be a topically applied formulation that can rapidly restore pigmentation without systemic absorption or cutaneous side effects.
Tixel is a novel non-laser thermo-mechanical system (Tixel, Novoxel, and Israel), that is, a registered medical device in several countries worldwide. The mechanism of action is by evaporation and thermal decomposition of stratum corneum and the dehydration of epidermis.
The aim of our study is to evaluate the clinical effectiveness and safety profile of a novel approach using an energy-based device (Tixel, Novoxel, and Israel), followed by the topical application of Bethametasone for the treatment of vitiligo.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Recruited patients will have at least 3 × 3 cm patches in greatest dimensions in symmetrical locations for example both forearms, both legs ect. one side will serve as target lesion and the other willl rec. Patients receiving topical or systemic therapy for vitiligo will be kept off treatment for 4 weeks prior to start of therapy. each patient will have 2 different treatments. one side - topical application of Betamethasone alone other side - enhanced Transcutaneous Delivery of Topical Betamethasone for the Treatment after treatment with Tixel. each patient will be treated with the 2 modes of treatments - 2 arms in symmetrical locations
| Arm | Type | Receives |
|---|---|---|
| topical treatment | Other | Other: Topical treatmentTopical Betamethasone for the Treatment of Vitiligo Disease |
| Enhanced Transcutaneous Delivery | Experimental | Other: Enhanced Transcutaneous Delivery of Topical Betamethasone after the treatment with TixelEnhanced Transcutaneous Delivery of Topical Betamethasone after a treatment with Tixel device for the Treatment of Vitiligo Disease |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Symmetric vitiligo
- Stable vitiligo for at least six months (< 10% change in the last 6 months)
- Diagnosis was made clinically by a dermatologist
- Age over 18 -70 years men and women
Key exclusion criteria (9 listed)
- Non Stable vitiligo
- Contraindications for phototherapy
- Pregnancy or lactation
- Lack of willingness to go to phototherapy 3 times a week for at least 6 months
- Segmental Vitiligo
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 |
|---|---|---|
| Enhanced Transcutaneous Delivery of Topical Betamethasone after the treatment with TixelTixel Parameters: exposure time 6-8 milliseconds, 400-600 μm protrusion | Other | Enhanced Transcutaneous Delivery |
| Topical treatmentbetamethasone ointment treatment once per day | Other | topical treatment |
Primary outcome
Patient's global impression of change (PGIC) scale
Time frame: up to 2 years
The self-report measure Patient Global Impression of Change (PGIC) reflects a patient's belief about the efficacy of treatment. Although widely used in chronic pain clinical trials, PGIC's validity has not been formally assessed. PGIC is a 7 point scale depicting a patient's rating of overall improvement. Patients rate their change as "1- very much improved," "2- much improved," "3- minimally improved," "4-no change," "5- minimally worse," "6- much worse," or "7- very much worse."
Dermatology life quality index (DLQI)
Time frame: up to 2 years
The Dermatology life Quality Index (DLQI) is a ten-question questionnaire used to measure the impact of skin disease on the quality of life of an affected person. There are 10 questions, covering the following topics: symptoms, embarrassment, shopping and home care, clothes, social and leisure, sport, work or study, close relationships, sex, treatment. Each question refers to the impact of the skin disease on the patient's life over the previous week Each question is scored from 0 to 3, giving a possible score range from 0 (meaning no impact of skin disease on quality of life) to 30 (meaning maximum impact on quality of life). A series of validated "band descriptors" were described in 2005 to give meaning to the scores of the DLQI. These bands are as follows: 0-1 = No effect on patient's life, 2-5 = Small effect, 6-10 = Moderate effect, 11-20 = Very large effect, 21-30 = Extremely large effect.
Physician's global assessment (PGA) scale
Time frame: up to 2 years
0-4 scale of improvement 0- Absent: 0% 1. Minimal: < 25% 2. Mild: 26-50% 3. Moderate: 51-75% 4 -Marked to complete: > 75%.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 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.
Mor Pavlovski, MD principal investigator
Sourasky Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enhanced Transcutaneous Delivery of Topical Betamethasone after the treatment with Tixel and Topical treatment in people with Vitiligo, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
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 4 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 10 Feb 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 Israel. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mor Pavlovski, MD (+972-527360388, Mashapavl@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient's global impression of change (PGIC) scale (time frame: up to 2 years). The study lists 3 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 10 Feb 2022.