NCT01388517

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jan 2008

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2010

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 30, 2011

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 6, 2011

Completed
Last Updated

September 26, 2012

Status Verified

September 1, 2012

Enrollment Period

2.6 years

First QC Date

June 30, 2011

Last Update Submit

September 25, 2012

Conditions

Pityriasis Alba

Keywords

Pityriasis albaTacrolimusCalcitriolPetrolatum

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (3)

  • Change in transepidermal water loss of PA lesions

    6 weeks

  • Investigator's repigmentation improvement

    9 weeks

  • Reduction of the affected area by image analysis software

    9 weeks

Study Arms (3)

Calcitriol

ACTIVE COMPARATOR

Repigmentation treatment for the relief of hypopigmented pityriasis alba lesions

Drug: Calcitriol

Tacrolimus

ACTIVE COMPARATOR

Treatment for the relief of hypopigmented pityriasis alba lesions

Drug: Tacrolimus

Petrolatum

PLACEBO COMPARATOR

Petrolatum treatment for the relief of hypopigmented pityriasis alba lesions

Drug: Petrolatum

Interventions

TacrolimusDRUG

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

Also known as: Protopic, FK506 ointment
Tacrolimus
CalcitriolDRUG

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

Also known as: Silkis, Topical Vitamin D analogs
Calcitriol
PetrolatumDRUG

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

Also known as: Vaseline, Acuaphore
Petrolatum

Eligibility Criteria

Age2 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Diagnosis of Pityriasis alba with well defined lesions greater than 3 cm2.

You may not qualify if:

  • Diagnosis of Atopic Dermatitis
  • Skin disorders other than Pityriasis alba
  • Systemic disorders
  • Treatment during the last 8 weeks for this condition

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

San Luis Potosí City, San Luis Potosí, 78210, Mexico

Location

MeSH Terms

Conditions

Dandruff

Interventions

TacrolimusCalcitriolPetrolatum

Condition Hierarchy (Ancestors)

DermatitisSkin DiseasesSkin and Connective Tissue DiseasesScalp Dermatoses

Intervention Hierarchy (Ancestors)

MacrolidesLactonesOrganic ChemicalsDihydroxycholecalciferolsHydroxycholecalciferolsCholecalciferolCholestenesCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSterolsVitamin DSecosteroidsMembrane LipidsLipidsHydrocarbons

Study Officials

  • Juan P Castanedo-Cazares, MD

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

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor of dermatology

Study Record Dates

First Submitted

June 30, 2011

First Posted

July 6, 2011

Study Start

January 1, 2008

Primary Completion

August 1, 2010

Study Completion

January 1, 2011

Last Updated

September 26, 2012

Record last verified: 2012-09

Locations

ME(1)