Enhanced Transcutaneous Delivery of Betamethasone for the Treatment of Vitiligo
Primary Purpose
Vitiligo
Status
Recruiting
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Enhanced Transcutaneous Delivery of Topical Betamethasone after the treatment with Tixel
Topical treatment
Sponsored by
About this trial
This is an interventional treatment trial for Vitiligo focused on measuring Vitiligo, Tixel, Enhanced Transcutaneous Delivery
Eligibility Criteria
Inclusion criteria:
- 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
Exclusion criteria:
- 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
Sites / Locations
- Department of Dermatology, Tel Aviv Sourasky medical centerRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Experimental
Arm Label
topical treatment
Enhanced Transcutaneous Delivery
Arm Description
Topical Betamethasone for the Treatment of Vitiligo Disease
Enhanced Transcutaneous Delivery of Topical Betamethasone after a treatment with Tixel device for the Treatment of Vitiligo Disease
Outcomes
Primary Outcome Measures
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."
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.
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%.
Secondary Outcome Measures
Full Information
NCT ID
NCT05233735
First Posted
October 5, 2021
Last Updated
February 9, 2022
Sponsor
Tel-Aviv Sourasky Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT05233735
Brief Title
Enhanced Transcutaneous Delivery of Betamethasone for the Treatment of Vitiligo
Official Title
An Enhanced Transcutaneous Delivery of Topical Betamethasone for the Treatment of Vitiligo Disease
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2021 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tel-Aviv Sourasky Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vitiligo
Keywords
Vitiligo, Tixel, Enhanced Transcutaneous Delivery
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Non-Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
topical treatment
Arm Type
Other
Arm Description
Topical Betamethasone for the Treatment of Vitiligo Disease
Arm Title
Enhanced Transcutaneous Delivery
Arm Type
Experimental
Arm Description
Enhanced Transcutaneous Delivery of Topical Betamethasone after a treatment with Tixel device for the Treatment of Vitiligo Disease
Intervention Type
Other
Intervention Name(s)
Enhanced Transcutaneous Delivery of Topical Betamethasone after the treatment with Tixel
Intervention Description
Tixel Parameters: exposure time 6-8 milliseconds, 400-600 μm protrusion
Intervention Type
Other
Intervention Name(s)
Topical treatment
Intervention Description
betamethasone ointment treatment once per day
Primary Outcome Measure Information:
Title
Patient's global impression of change (PGIC) scale
Description
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."
Time Frame
up to 2 years
Title
Dermatology life quality index (DLQI)
Description
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.
Time Frame
up to 2 years
Title
Physician's global assessment (PGA) scale
Description
0-4 scale of improvement 0- Absent: 0%
Minimal: < 25%
Mild: 26-50%
Moderate: 51-75% 4 -Marked to complete: > 75%.
Time Frame
up to 2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion criteria:
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
Exclusion criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mor Pavlovski, MD
Phone
+972-527360388
Email
Mashapavl@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mor Pavlovski, MD
Organizational Affiliation
Sourasky Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Dermatology, Tel Aviv Sourasky medical center
City
Tel Aviv
ZIP/Postal Code
64239
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mor Pavlovski, MD
Phone
972527360388
Email
Mashapavl@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Enhanced Transcutaneous Delivery of Betamethasone for the Treatment of Vitiligo
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