Enhanced Transcutaneous Delivery of Betamethasone for the Treatment of Vitiligo

Tel Aviv Sourasky Medical Center

Status: Enrolling

Conditions: Vitiligo

Treatments: Other: Enhanced Transcutaneous Delivery of Topical Betamethasone after the treatment with Tixel; Other: Topical treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT05233735

0853-20

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

topical treatment

Other group

Description:

Topical Betamethasone for the Treatment of Vitiligo Disease

Treatment:

Other: Topical treatment

Enhanced Transcutaneous Delivery

Experimental group

Description:

Enhanced Transcutaneous Delivery of Topical Betamethasone after a treatment with Tixel device for the Treatment of Vitiligo Disease

Treatment:

Other: Enhanced Transcutaneous Delivery of Topical Betamethasone after the treatment with Tixel