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The Value of Using Mini-oral Pulse Steroid Therapy Along With Non Cultured Epidermal Cell Suspension (NCES) in Stable Resistant Vitiligo

ConditionVitiligo
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCairo University

About this trial

Assessing the additive value of mini-oral pulse steroid therapy in surgical treatment of acral and difficult to treat sites of vitiligo

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients with non-segmental vitiligo (NSV) with acral or resistant lesions over the elbows and knees, that has not responded to conventional treatment

Stability for ≥ 1 year

Age ≥18 years

Lack of topical treatment for at least 1 month prior to surgery and systemic treatment for at least 3 months prior to surgery.

Disqualifiers

Non acral NSV responsive to conventional treatment modalities

Active vitiligo; new lesions, expansion of old lesions, confetti like lesions, ill-defined edges or koebnerization in < 1 year

Age < 18 years.

Pregnant females.

Trial design

Design model

Parallel

Treatments tested in this trial

  • oral steroid-dexamethasone

    Drug

    this study is the first according to the best of our knowledge assessing the value of adding mini oral pulse steroid therapy to non cultured epidermal suspension in treatment of stable acral and difficult to treat vitiligo

  • non cultured epidermal suspension

    Procedure/Surgery

    this is the best surgical technique for surgical treatment of vitiligo that would be done for both arms

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Vitiligo surgery with added mini-oral pulse steroid therapy in the peri-surgical periodActive comparator 2 interventions
Group B: Vitiligo surgery without mini-oral pulse steroid therapyActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

comparing percent change in pigmentation in both arms

• Comparing percent change of pigmentation as per VESTA score after 3 months of treatment with NCES with and without mini oral pulse steroids.

Time frame
3 months
2

comparing percent change in surface area in both arms

• Comparing percent change in the surface area of the depigmented patch following NCES using point counting technique.

Time frame
3 months

Secondary outcomes

1

comparing physician global assessment in both arms

• Comparing physician global assessment after treatment with NCES with and without oral mini-pulse therapy

Time frame
3 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Cairo University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: