Pityriasis Alba Clinical Trial
Official title:
A Double Blind Randomized Trial, Placebo-controled of 0.0003% Calcitriol Ointment Versus 0.1% Tacrolimus Ointment in the Treatment of Pityriasis Alba
Verified date | September 2012 |
Source | Universidad Autonoma de San Luis Potosí |
Contact | n/a |
Is FDA regulated | No |
Health authority | Mexico: Ministry of Health |
Study type | Interventional |
Pityriasis alba (PA) is a frequent cause of consultation in tropical areas due to its chronic course, trend to relapse and aesthetic impact. Currently, no treatment is widely accepted. The objective is to assess the calcitriol and tacrolimus ointment efficacy in the treatment of PA compared with petrolatum. Twenty lesions on the face greater than 3 cm, in individuals of phototype IV-V, aged 3-18 years are going to be randomly assigned to receive petrolatum, calcitriol, and tacrolimus twice daily. No photoprotection is going to be indicated, and hygienic habits will not be modified. Patients will be evaluated at baseline and for 9 weeks, by means of Transepidermal Water Loss (TEWL), colorimetry, clinically and by photography control.
Status | Completed |
Enrollment | 39 |
Est. completion date | January 2011 |
Est. primary completion date | August 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 2 Years to 18 Years |
Eligibility |
Inclusion Criteria: - Diagnosis of Pityriasis alba with well defined lesions greater than 3 cm2. Exclusion Criteria: - Diagnosis of Atopic Dermatitis - Skin disorders other than Pityriasis alba - Systemic disorders - Treatment during the last 8 weeks for this condition |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Mexico | Dermatology Department. Hospital Central "Dr. Ignacio Morones Prieto" | San Luis Potosi |
Lead Sponsor | Collaborator |
---|---|
Universidad Autonoma de San Luis Potosí | Hospital Central "Dr. Ignacio Morones Prieto" |
Mexico,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Repigmentation of PA lesions measured by colorimetry | Quantification of the repigmentation of lesions by means of the L axis of the CIE system. 0 is pure white, 100 y total dark. | 9 weeks | No |
Secondary | Change in transepidermal water loss of PA lesions | Quantification of water loss measured by a evaporimeter in grams per squared meter per hour. Is an indirect measure of stratum corneum integrity. | 6 weeks | No |
Secondary | Investigator's repigmentation improvement | Clinical improvement is assessed by means of digital photographic registration (frontal, right, and left views). An independent observer clinically graded the global improvement as poor (0-25%), mild (26-50%), good (51-75%), and excellent (>75%). | 9 weeks | No |
Secondary | Reduction of the affected area by image analysis software | ImageJ software will be used to measure the lesion reduction area after treatments | 9 weeks | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT03443765 -
Serum 25(OH) Vitamin D and Total Serum Immunoglobulin E Levels in Patients With Pityriasis Alba
|
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Not yet recruiting |
NCT03834935 -
Efficacy of Topical Pimecrolimus in the Treatment of Pityriasis Alba
|
Phase 2/Phase 3 |