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

NCT03535051 | Completed

• 1 other identifier: 2
• Study Type: interventional
• Target: 27
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Stable Vitiligo

Keywords

vitiligo; fractional carbon dioxide laser; tacrolimus; drug delivery

Outcome Measures

Primary Outcomes (1)

• repigmentation

  reduction in Vitiligo Area Scoring Index of lesions

  5 months

Study Arms (2)

Treatment A

EXPERIMENTAL

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

Device: fractional carbon dioxide laser; Drug: Tacrolimus Oint 0.03%

Treatment B

ACTIVE COMPARATOR

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

Drug: Tacrolimus Oint 0.03%

Interventions

fractional carbon dioxide laser DEVICE

Monthly fractional carbon dioxide laser sessions

Also known as: fractional CO2 laser

Treatment A

Tacrolimus Oint 0.03% DRUG

topical daily tacrolimus ointment application

Also known as: Tacrolimus Oint 0.03% (Tarolimus)

Treatment A; Treatment B

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Patients younger than 12 years of age.
• Non-stable lesions.
• Non-symmetrical vitiligo.
• Patients currently on other lines of treatment.

Sponsors & Collaborators

• Kasr El Aini Hospital: lead

MeSH Terms

Conditions

Vitiligo

Condition Hierarchy (Ancestors)

Hypopigmentation; Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Ola M AbuZeid, MD

  Kasr Al Aini dermatology department

  STUDY DIRECTOR

• Dina ElSharkawy, MD

  Kasr Al Aini dermatology department

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident

Model Details: 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.

Study Record Dates

• First Submitted: May 12, 2018
• First Posted: May 24, 2018
• Study Start: January 1, 2015
• Primary Completion: January 1, 2017
• Study Completion: February 1, 2017
• Last Updated: September 13, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share