Stable Vitiligo
Conditions
Keywords
vitiligo, fractional carbon dioxide laser, tacrolimus, drug delivery
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.
Detailed 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.
Interventions
Monthly fractional carbon dioxide laser sessions
DRUGTacrolimus Oint 0.03%
topical daily tacrolimus ointment application
Sponsors
Kasr El Aini Hospital
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| repigmentation | 5 months | reduction in Vitiligo Area Scoring Index of lesions |
Outcome results
None listed