Enhanced Transcutaneous Delivery of Betamethasone for the Treatment of Vitiligo

NCT ID: NCT05233735

Last Updated: 2022-02-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-01
• Study Completion Date: 2024-12-31

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.

Conditions

Vitiligo

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

topical treatment

Topical Betamethasone for the Treatment of Vitiligo Disease

Group Type: OTHER

Topical treatment

Intervention Type: OTHER

betamethasone ointment treatment once per day

Enhanced Transcutaneous Delivery

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

Group Type: EXPERIMENTAL

Enhanced Transcutaneous Delivery of Topical Betamethasone after the treatment with Tixel

Intervention Type: OTHER

Tixel Parameters: exposure time 6-8 milliseconds, 400-600 μm protrusion

Interventions

Enhanced Transcutaneous Delivery of Topical Betamethasone after the treatment with Tixel

Tixel Parameters: exposure time 6-8 milliseconds, 400-600 μm protrusion

Intervention Type: OTHER

Topical treatment

betamethasone ointment treatment once per day

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Tel-Aviv Sourasky Medical Center

OTHER_GOV

Sponsor Role: lead

Responsible Party

Eli Sprecher, MD

MD, PhD, MBA

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mor Pavlovski, MD

Role: PRINCIPAL_INVESTIGATOR

Sourasky Medical Center

Locations

Department of Dermatology, Tel Aviv Sourasky medical center

Tel Aviv, , Israel

Site Status: RECRUITING

Countries

Israel

Central Contacts

Mor Pavlovski, MD

Role: CONTACT

Mashapavl@gmail.com

+972-527360388

Facility Contacts

Mor Pavlovski, MD

Role: primary

Mashapavl@gmail.com

972527360388

Other Identifiers

0853-20

Identifier Type: -

Identifier Source: org_study_id