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

Primary Purpose

Pityriasis Alba

Status
Completed
Phase
Phase 4
Locations
Mexico
Study Type
Interventional
Intervention
Tacrolimus
Calcitriol
Petrolatum
Sponsored by
Universidad Autonoma de San Luis Potosí
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pityriasis Alba focused on measuring Pityriasis alba, Tacrolimus, Calcitriol, Petrolatum

Eligibility Criteria

2 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

Calcitriol

Tacrolimus

Petrolatum

Arm Description

Repigmentation treatment for the relief of hypopigmented pityriasis alba lesions

Treatment for the relief of hypopigmented pityriasis alba lesions

Petrolatum treatment for the relief of hypopigmented pityriasis alba lesions

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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%).
Reduction of the affected area by image analysis software
ImageJ software will be used to measure the lesion reduction area after treatments

Full Information

First Posted
June 30, 2011
Last Updated
September 25, 2012
Sponsor
Universidad Autonoma de San Luis Potosí
Collaborators
Hospital Central "Dr. Ignacio Morones Prieto"
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1. Study Identification

Unique Protocol Identification Number
NCT01388517
Brief Title
Clinical Trial of 0.0003% Calcitriol, 0.1% Tacrolimus, and Petrolatum for the Treatment of Pityriasis Alba
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2012
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
August 2010 (Actual)
Study Completion Date
January 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad Autonoma de San Luis Potosí
Collaborators
Hospital Central "Dr. Ignacio Morones Prieto"

4. Oversight

Data Monitoring Committee
No

5. Study Description

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 Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pityriasis Alba
Keywords
Pityriasis alba, Tacrolimus, Calcitriol, Petrolatum

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
39 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Calcitriol
Arm Type
Active Comparator
Arm Description
Repigmentation treatment for the relief of hypopigmented pityriasis alba lesions
Arm Title
Tacrolimus
Arm Type
Active Comparator
Arm Description
Treatment for the relief of hypopigmented pityriasis alba lesions
Arm Title
Petrolatum
Arm Type
Placebo Comparator
Arm Description
Petrolatum treatment for the relief of hypopigmented pityriasis alba lesions
Intervention Type
Drug
Intervention Name(s)
Tacrolimus
Other Intervention Name(s)
Protopic, FK506 ointment
Intervention Description
0.1% tacrolimus ointment to apply twice a day for 9 weeks on pytiriasis alba plaques.
Intervention Type
Drug
Intervention Name(s)
Calcitriol
Other Intervention Name(s)
Silkis, Topical Vitamin D analogs
Intervention Description
0.0003% calcitriol ointment to apply twice a day for 9 weeks on pytiriasis alba plaques.
Intervention Type
Drug
Intervention Name(s)
Petrolatum
Other Intervention Name(s)
Vaseline, Acuaphore
Intervention Description
Petrolatum ointment to apply twice a day for 9 weeks on pytiriasis alba plaques.
Primary Outcome Measure Information:
Title
Repigmentation of PA lesions measured by colorimetry
Description
Quantification of the repigmentation of lesions by means of the L axis of the CIE system. 0 is pure white, 100 y total dark.
Time Frame
9 weeks
Secondary Outcome Measure Information:
Title
Change in transepidermal water loss of PA lesions
Description
Quantification of water loss measured by a evaporimeter in grams per squared meter per hour. Is an indirect measure of stratum corneum integrity.
Time Frame
6 weeks
Title
Investigator's repigmentation improvement
Description
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%).
Time Frame
9 weeks
Title
Reduction of the affected area by image analysis software
Description
ImageJ software will be used to measure the lesion reduction area after treatments
Time Frame
9 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Juan P Castanedo-Cazares, MD
Organizational Affiliation
Dermatology Department. Hospital Central "Dr. Ignacio Morones Prieto". San Luis Potosi, México
Official's Role
Study Chair
Facility Information:
Facility Name
Dermatology Department. Hospital Central "Dr. Ignacio Morones Prieto"
City
San Luis Potosi
ZIP/Postal Code
78210
Country
Mexico

12. IPD Sharing Statement

Learn more about this trial

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

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