Enhanced Transcutaneous Delivery of Betamethasone for the Treatment of Vitiligo
An Enhanced Transcutaneous Delivery of Topical Betamethasone for the Treatment of Vitiligo Disease
1 other identifier
interventional
20
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2021
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2021
CompletedFirst Submitted
Initial submission to the registry
October 5, 2021
CompletedFirst Posted
Study publicly available on registry
February 10, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2024
CompletedFebruary 10, 2022
February 1, 2022
3 years
October 5, 2021
February 9, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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."
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.
up to 2 years
Physician's global assessment (PGA) scale
0-4 scale of improvement 0- Absent: 0% 1. Minimal: \< 25% 2. Mild: 26-50% 3. Moderate: 51-75% 4 -Marked to complete: \> 75%.
up to 2 years
Study Arms (2)
topical treatment
OTHERTopical Betamethasone for the Treatment of Vitiligo Disease
Enhanced Transcutaneous Delivery
EXPERIMENTALEnhanced Transcutaneous Delivery of Topical Betamethasone after a treatment with Tixel device for the Treatment of Vitiligo Disease
Interventions
Tixel Parameters: exposure time 6-8 milliseconds, 400-600 μm protrusion
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
- Exit criteria:
- Intolerable to the the study treatment
- Lack of patient's compliance
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Dermatology, Tel Aviv Sourasky medical center
Tel Aviv, 64239, Israel
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mor Pavlovski, MD
Sourasky Medical Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, PhD, MBA
Study Record Dates
First Submitted
October 5, 2021
First Posted
February 10, 2022
Study Start
January 1, 2021
Primary Completion
December 31, 2023
Study Completion
December 31, 2024
Last Updated
February 10, 2022
Record last verified: 2022-02
Data Sharing
- IPD Sharing
- Will not share