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

NCT ID: NCT01388517

Last Updated: 2012-09-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2011-01-31

Brief Summary

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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 Description

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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.

Conditions

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Pityriasis Alba

Keywords

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Pityriasis alba Tacrolimus Calcitriol Petrolatum

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Calcitriol

Repigmentation treatment for the relief of hypopigmented pityriasis alba lesions

Group Type ACTIVE_COMPARATOR

Calcitriol

Intervention Type DRUG

0.0003% calcitriol ointment to apply twice a day for 9 weeks on pytiriasis alba plaques.

Tacrolimus

Treatment for the relief of hypopigmented pityriasis alba lesions

Group Type ACTIVE_COMPARATOR

Tacrolimus

Intervention Type DRUG

0.1% tacrolimus ointment to apply twice a day for 9 weeks on pytiriasis alba plaques.

Petrolatum

Petrolatum treatment for the relief of hypopigmented pityriasis alba lesions

Group Type PLACEBO_COMPARATOR

Petrolatum

Intervention Type DRUG

Petrolatum ointment to apply twice a day for 9 weeks on pytiriasis alba plaques.

Interventions

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Tacrolimus

0.1% tacrolimus ointment to apply twice a day for 9 weeks on pytiriasis alba plaques.

Intervention Type DRUG

Calcitriol

0.0003% calcitriol ointment to apply twice a day for 9 weeks on pytiriasis alba plaques.

Intervention Type DRUG

Petrolatum

Petrolatum ointment to apply twice a day for 9 weeks on pytiriasis alba plaques.

Intervention Type DRUG

Other Intervention Names

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Protopic FK506 ointment Silkis Topical Vitamin D analogs Vaseline Acuaphore

Eligibility Criteria

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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
Minimum Eligible Age

2 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital Central "Dr. Ignacio Morones Prieto"

OTHER

Sponsor Role collaborator

Universidad Autonoma de San Luis Potosí

OTHER

Sponsor Role lead

Responsible Party

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Juan Pablo Castanedo Cazares

Clinical Professor of dermatology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Juan P Castanedo-Cazares, MD

Role: STUDY_CHAIR

Dermatology Department. Hospital Central "Dr. Ignacio Morones Prieto". San Luis Potosi, México

Locations

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Dermatology Department. Hospital Central "Dr. Ignacio Morones Prieto"

San Luis Potosí City, San Luis Potosí, Mexico

Site Status

Countries

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Mexico

Other Identifiers

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PA-CALTAC

Identifier Type: -

Identifier Source: org_study_id