Clinical Trial: Clinical Trial of 0.0003% Calcitriol, 0.1% Tacrolimus, and Petrolatum for the Treatment of Pityriasis Alba

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief Summary: 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.

Detailed Summary:

Pityriasis alba (PA) is a benign inflammatory dermatosis affecting about 5% of infantile population, frequently seen in tropical areas of the world. This entity has received many synonymous such as chronic impetigo and erythema streptogenes, but its actual name was given from Hazen. PA is also considered a minor criterion for the diagnosis of atopic dermatitis. It is characterized by hypopigmented, irregular plaques with well-defined borders, covered by fine scales; it affects mainly face, limbs and occasionally thorax.

Its etiology is still unknown, although infectious mechanisms and vitamin and minerals deficiencies have been implicated, a causal relationship has not been recognized. However, excessive and unprotected sun exposure is considered the most important causal factor involved. However, studies from stratum corneum from of PA lesions have described defects in hygroscopicity and water-holding capacity detectable by water sorption-desorption test, this suggests that the condition is similar to a dermatitic change and its hypopigmentation may be consequence of a postinflammatory mechanism.

The study population will include at least 20 lesions in individuals with phototype IV-V, affected symmetrically by PA on the face. Their selected age will be less than 18 years. Patients with other dermatoses, including atopic dermatitis, use of any systemic or topical medication during the past 4 weeks will be excluded. Informed consent was obtained from the parents and children before entering the study, which was approved by the local ethical committee (Institutional Review Board).

Patients will be randomly assigned in a double-blind manner to receive on the lesions 0.0003% calcitriol (Galderma, France), 0.1% tacrolimus (Astellas, Pharma, USA), and petrolatum (Aquaphor ointmen
Sponsor: Universidad Autonoma de San Luis Potosí

Current Primary Outcome: Repigmentation of PA lesions measured by colorimetry [ Time Frame: 9 weeks ]

Quantification of the repigmentation of lesions by means of the L axis of the CIE system. 0 is pure white, 100 y total dark.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Change in transepidermal water loss of PA lesions [ Time Frame: 6 weeks ]
    Quantification of water loss measured by a evaporimeter in grams per squared meter per hour. Is an indirect measure of stratum corneum integrity.
  • Investigator's repigmentation improvement [ Time Frame: 9 weeks ]
    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%).
  • Reduction of the affected area by image analysis software [ Time Frame: 9 weeks ]
    ImageJ software will be used to measure the lesion reduction area after treatments


Original Secondary Outcome: Same as current

Information By: Universidad Autonoma de San Luis Potosí

Dates:
Date Received: June 30, 2011
Date Started: January 2008
Date Completion:
Last Updated: September 25, 2012
Last Verified: September 2012