Vitiligo Vulgaris
Conditions
Brief summary
Vitiligo is an acquired disorder of the skin and mucous membranes characterized by well circumscribed depigmented macules and patches that occur secondary to selective destruction of melanocytes (Zhang et al., 2009). Generalized vitiligo is the most common clinical presentation and often involves the face and acral regions (Alikhan et al., 2011).
Detailed description
Combined vitiligo treatments have been found to be superior to monotherapies regarding efficacy, early response and safety (Kandaswamy et al., 2013). Fractionated lasers represent a new modality for skin resurfacing based on the theory of fractional photothermolysis introduced by Manstein et al (2004). These lasers were shown to be efficient in treating facial photo aging changes as well as scars, and have an improved safety and recovery profile compared with traditional CO2 laser resurfacing. Fractionated lasers do not ablate the entire epidermis and thereafter leave intact skin between coagulated necrotic columns. This characteristic facilitates the skin healing process (Bogdan et al., 2010)
Interventions
DRUGTacrolimus ointment
3 sessions of fractional CO2 laser one month apart Patients will start treatment Tarolimus ointment twice daily for 3 months.
3 sessions of fractional CO2 laser one month apart Patients will start treatment Calcipotriol ointment twice daily for 3 months.
DRUGNB-UVB
3 sessions of fractional CO2 laser one month apart Patients will start treatment NB-UVB phototherapy twice weekly for 3 months
Sponsors
Assiut University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* patients with stable vitiligo * nonsegmental vitiligo will be recruited * A patient reporting no new lesions, no progression of existing lesions, and absence of Koebner phenomenon during the previous year
Exclusion criteria
1. Patients with active infection. 2. Reported histories of koebnerization. 3. History of keloid formation or hypertrophic scars. 4. Pregnant or lactating females. 5. Bleeding tendency.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 1- Re-pigmentation : that will be subjectively rated with a previously reported scoring system (Ghiya et al., 2016). | up to 3 months | G0, \< 25% repigmentation (poor) * G1, 25-50% repigmentation (fair) * G2, 50-75% repigmentation (good) * G3 \> 75% repigmentation (excellent). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The VASI percent change | every month for 3 months | The VASI percent change will be calculated by subtracting the pre- procedure VASI score from the post-procedure VASI score and dividing by the pre-procedure VASI score. |
Other
| Measure | Time frame | Description |
|---|---|---|
| - Frequency and types of side effects. | 3 months | pain, scarring, hyperpigmentation |
| - Patient satisfaction. The patient overall satisfaction will be assessed after 6 months according to Wong and Vasconez (2011). Overall satisfaction: | 3 months | 1. dissatisfied 2. neutral 3. somewhat satisfied 4. moderately satisfied 5. very satisfied |
Contacts
Primary Contactyasmin tawfik, MD
Backup Contactreham maher abdel gaber
Outcome results
None listed