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

Stable Vitiligo Clinical Trial

Official title:

The Efficiency of Fractional-Laser Resurfacing Followed by Topical Tacrolimus 0.03% Cream Versus Topical Tacrolimus Alone in Stable Vitiligo: a Comparative Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03535051
• Other study ID #: 2
• Status: Completed
• Phase: N/A
• Start date: January 1, 2015
• Est. completion date: February 1, 2017

Study information

• Verified date: September 2018
• Source: Kasr El Aini Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: February 1, 2017
• Est. primary completion date: January 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

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.

Exclusion criteria:

• Patients younger than 12 years of age.

• Non-stable lesions.

• Non-symmetrical vitiligo.

• Patients currently on other lines of treatment.

Related Conditions & MeSH terms

• Stable Vitiligo
• Vitiligo

Intervention

Device:
• fractional carbon dioxide laser
Monthly fractional carbon dioxide laser sessions

Drug:
• Tacrolimus Oint 0.03%
topical daily tacrolimus ointment application

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Kasr El Aini Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	repigmentation	reduction in Vitiligo Area Scoring Index of lesions	5 months