Efficiency of Fractional-Laser Resurfacing Followed by Topical Tacrolimus 0.03% Cream vs Tacrolimus Alone in Vitiligo

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-01

Study Completion Date

2017-02-01

Brief Summary

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The aim the clinical trial was to find out whether fractional CO₂ laser sessions in combination with application of daily topical tacrolimus 0.03% would enhance the action of the drug and pose as a possible combination treatment option for stable vitiligo lesions. This combination treatment was applied to one side of the body and the response was compared to the response of the lesions on the other side of the body to daily topical tacrolimus 0.03% alone, which was used as control.

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Detailed Description

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Each patient included in the study received treatment A on the lesions on one side of his/her body, and treatment B on the other side.

Treatment A included 4 monthly sessions of fractional CO₂ laser on the lesions plus application of topical tacrolimus 0.03% (Tarolimus) on the lesions 6 hours after each session and twice daily in between the sessions and for 1 month after the last session.

Treatment B included only the application of topical tacrolimus 0.03% (Tarolimus) on the lesions twice daily for 5 months.

Fractional laser The device used was DEKA, SmartXide DOT (Dermal Optical Thermolysis), Italy fractional Carbon Dioxide Laser (fig. 8). This device is an ablative fractional 10,6000 nm CO² Laser with variable pulse duration (0.2-2 ms), 350-μm beam spot size, scanner area of 15x15 mm and penetration depth between 200 to 1,500 μm.

Tacrolimus ointment 0.03% (Tarolimus) Applied on the lesions treated by fractional CO² laser 6 hours after each laser session, then twice daily in between the sessions and 1 month after the last session.

Applied on the lesions on the other half of the body (not treated with fractional CO² laser) twice daily for 4 months.

Conditions

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Stable Vitiligo

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

A total of 152 lesions in different areas of the body were evaluated in the study. Seventy six lesions received the combination treatment and 76 received topical tacrolimus alone. Forty six lesions were in the head and neck region, 40 were acral in location, 36 were in the upper and lower limbs, 22 lesions were over bony prominences and 8 lesions were present on the trunk.

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Treatment A

Combination treatment of fractional carbon dioxide laser monthly sessions and topical tacrolimus 0.03% daily application (Tacrolimus Oint 0.03%)

Group Type EXPERIMENTAL

fractional carbon dioxide laser

Intervention Type DEVICE

Monthly fractional carbon dioxide laser sessions

Tacrolimus Oint 0.03%

Intervention Type DRUG

topical daily tacrolimus ointment application

Treatment B

Monotherapy with only topical tacrolimus 0.03% daily intervention: Tacrolimus Oint 0.03%

Group Type ACTIVE_COMPARATOR

Tacrolimus Oint 0.03%

Intervention Type DRUG

topical daily tacrolimus ointment application

Interventions

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fractional carbon dioxide laser

Monthly fractional carbon dioxide laser sessions

Intervention Type DEVICE

Tacrolimus Oint 0.03%

topical daily tacrolimus ointment application

Intervention Type DRUG

Other Intervention Names

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fractional CO2 laser Tacrolimus Oint 0.03% (Tarolimus)

Eligibility Criteria

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Inclusion Criteria

* Patients with stable vitiligo for at least 6 months, stability being defined as no eruption of fresh lesions and no extension of pre-existing lesions.
* Age ≧ 12 years.
* Symmetrical vitiligo.
* Three month treatment-free period.