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
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.
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 ointment)in all of them. All subjects were instructed to apply the
treatment twice daily. Sunscreen will not be indicated, and hygienic habits are not being
changed. Hypopigmented areas are going to be initially evaluated and supervised at 3, 6 and
9 weeks. Digital photographic registration(frontal, right, and left views) with an SLR Fuji
FinepixS1pro camera will be taken and analysed by ImageJ software to quantify the reduction
area of the plaques. The methods of assessment involve clinical evaluation by investigators,
an independent observer, and by the transepidermal water loss (TEWL) with an evaporimeter
(Dermalab, Cortex Technology, Denmark), and pigmentary changes using a colorimeter
(Chromameter CR-300, Minolta, Osaka, Japan). Water loss will be recorded on each plaque for
60 seconds, as well as the L* (luminosity) and a* (erythema) axis. All adverse effects will
be recorded. Statistical analysis was performed using T student, the level of significance
was set at 5%. And clinical evaluation will be analysed by means of chi square tests.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT03443765 -
Serum 25(OH) Vitamin D and Total Serum Immunoglobulin E Levels in Patients With Pityriasis Alba
|
||
Not yet recruiting |
NCT03834935 -
Efficacy of Topical Pimecrolimus in the Treatment of Pityriasis Alba
|
Phase 2/Phase 3 |