None listed
Conditions
Brief summary
Vitiligo is a common acquired pigmentation disorder with unknown cause that results in destruction of melanocyte cells. In 50% of cases the disease is started before twenty years of old that may lead to significant psycho-spiritual impairments in children. There are various therapeutic options for the treatment of vitiligo, however, none of these treatments are quite effective and safe so far. The resistance to treatments, recurrence and therapeutic side effects are some of the complications that may happen with the current therapeutic options. All these treatment options have their own limitations due to the side effects and unsuitable therapeutic responses. So efforts to find new treatment options covering these pitfalls are still continued. Recently in some limited studies, topical immunomodulators (TIMS) in the calcineurin inhibitor family (such as topical tacrolimus and pimecrolimus) have been used for the treatment of vitiligo in children as safe and efficient therapeutic options. These are safe drugs but the problem of high cost has limited their use as a routine treatment. However, combination therapy of TIMS with other therapeutic modalities and drugs may result in increased efficacy, decreased side effects and cost of treatment and shortening the duration of treatment. In the current study, we decide to compare the therapeutic effects of single TIMS therapy, with combination therapy of mometazone ointment and pimecrolimus cream for the treatment of vitiligo in children. As literature explains combination of two drugs in form of “week day/weekend” regime has increased the therapeutic effects with little side effects in the treatment of some of the skin disorders such as psoriasis, so we decided to try this new method in the treatment of children with Vitiligo.
Interventions
In each patient three lesions with approximately equal size, in the same anatomic location (limbs, trunk, sun exposed or covered areas) will be selected. Topical pimecrolimus cream 1% will be applied to the first lesion twice daily, topical mometazone furoat 0.1% ointment will be applied for the second lesion every night, and pimecrolimus cream 1% and topical mometazone ointment 0.1% will be applied to the third lesion twice daily for the first 5 days and the subsequent 2 days of the week at nig
In each patient three lesions with approximately equal size, in the same anatomic location (limbs, trunk, sun exposed or covered areas) will be selected. Topical pimecrolimus cream 1% will be applied to the first lesion twice daily, topical mometazone furoat 0.1% ointment will be applied for the second lesion every night, and pimecrolimus cream 1% and topical mometazone ointment 0.1% will be applied to the third lesion twice daily for the first 5 days and the subsequent 2 days of the week at nights respectively. All three treatments are administered simultaneously over the same three month period (total treatment period 3 months) and after that patients will be followed up for another 3 months as well.
Sponsors
Kerman Medical University
Study design
Allocation
Non-randomised trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
2 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
No history of any kind of treatments for vitiligo since 1 month of starting the study.
Exclusion criteria
The patients with uncontrolled systemic diseases, renal failure, autoimmune disorders, history of sensitivity to pimecrolimus cream and topical steroids/macrolides, and unstable vitiligo will be excluded from the study.
Outcome results
None listed