Clinical trial NCT05233735: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Vitiligo
Keywords: Vitiligo
Tixel
Enhanced Transcutaneous Delivery
Lead sponsor: Tel-Aviv Sourasky Medical Center
Sponsor class: OTHER_GOV
First posted: 2022-02-10
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention 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
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion criteria:

1. Symmetric vitiligo
2. Stable vitiligo for at least six months (\< 10% change in the last 6 months)
3. Diagnosis was made clinically by a dermatologist
4. Age over 18 -70 years men and women

Exclusion criteria:

1. Non Stable vitiligo
2. Contraindications for phototherapy
3. Pregnancy or lactation
4. Lack of willingness to go to phototherapy 3 times a week for at least 6 months
5. Segmental Vitiligo
6. Phototherapy or topical therapy for vitiligo in the last 1 month.

Exit criteria:

1. Intolerable to the the study treatment
2. Lack of patient's compliance

Primary outcomes:
measure: Patient's global impression of change (PGIC) scale
timeFrame: up to 2 years
measure: Dermatology life quality index (DLQI)
timeFrame: up to 2 years
measure: Physician's global assessment (PGA) scale
timeFrame: up to 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Tel Aviv
country: Israel
facility: Department of Dermatology, Tel Aviv Sourasky medical center
Study officials:
affiliation: Sourasky Medical Center
name: Mor Pavlovski, MD
role: PRINCIPAL_INVESTIGATOR
References: