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

This study has been completed.
Sponsor:
Collaborator:
Hospital Central "Dr. Ignacio Morones Prieto"
Information provided by (Responsible Party):
Juan Pablo Castanedo Cazares, Universidad Autonoma de San Luis Potosí
ClinicalTrials.gov Identifier:
NCT01388517
First received: June 30, 2011
Last updated: September 25, 2012
Last verified: September 2012
  Purpose

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.


Condition Intervention Phase
Pityriasis Alba
Drug: Tacrolimus
Drug: Calcitriol
Drug: Petrolatum
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Universidad Autonoma de San Luis Potosí:

Primary Outcome Measures:
  • Repigmentation of PA lesions measured by colorimetry [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    ImageJ software will be used to measure the lesion reduction area after treatments


Enrollment: 39
Study Start Date: January 2008
Study Completion Date: January 2011
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Calcitriol
Repigmentation treatment for the relief of hypopigmented pityriasis alba lesions
Drug: Calcitriol
0.0003% calcitriol ointment to apply twice a day for 9 weeks on pytiriasis alba plaques.
Other Names:
  • Silkis
  • Topical Vitamin D analogs
Active Comparator: Tacrolimus
Treatment for the relief of hypopigmented pityriasis alba lesions
Drug: Tacrolimus
0.1% tacrolimus ointment to apply twice a day for 9 weeks on pytiriasis alba plaques.
Other Names:
  • Protopic
  • FK506 ointment
Placebo Comparator: Petrolatum
Petrolatum treatment for the relief of hypopigmented pityriasis alba lesions
Drug: Petrolatum
Petrolatum ointment to apply twice a day for 9 weeks on pytiriasis alba plaques.
Other Names:
  • Vaseline
  • Acuaphore

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.

  Eligibility

Ages Eligible for Study:   2 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01388517

Locations
Mexico
Dermatology Department. Hospital Central "Dr. Ignacio Morones Prieto"
San Luis Potosi, Mexico, 78210
Sponsors and Collaborators
Universidad Autonoma de San Luis Potosí
Hospital Central "Dr. Ignacio Morones Prieto"
Investigators
Study Chair: Juan P Castanedo-Cazares, MD Dermatology Department. Hospital Central "Dr. Ignacio Morones Prieto". San Luis Potosi, México
  More Information

No publications provided

Responsible Party: Juan Pablo Castanedo Cazares, Clinical Professor of dermatology, Universidad Autonoma de San Luis Potosí
ClinicalTrials.gov Identifier: NCT01388517     History of Changes
Other Study ID Numbers: PA-CALTAC
Study First Received: June 30, 2011
Last Updated: September 25, 2012
Health Authority: Mexico: Ministry of Health

Keywords provided by Universidad Autonoma de San Luis Potosí:
Pityriasis alba
Tacrolimus
Calcitriol
Petrolatum

Additional relevant MeSH terms:
Pityriasis
Dandruff
Skin Diseases, Papulosquamous
Skin Diseases
Dermatitis
Scalp Dermatoses
Calcitriol
Tacrolimus
Petrolatum
Calcium Channel Agonists
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Vasoconstrictor Agents
Cardiovascular Agents
Therapeutic Uses
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Immunosuppressive Agents
Immunologic Factors
Emollients
Dermatologic Agents

ClinicalTrials.gov processed this record on September 30, 2014