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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01388517
Recruitment Status : Completed
First Posted : July 6, 2011
Last Update Posted : September 26, 2012
Hospital Central "Dr. Ignacio Morones Prieto"
Information provided by (Responsible Party):
Juan Pablo Castanedo Cazares, Universidad Autonoma de San Luis Potosí

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.

Condition or disease Intervention/treatment Phase
Pityriasis Alba Drug: Tacrolimus Drug: Calcitriol Drug: Petrolatum Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 39 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : January 2008
Actual Primary Completion Date : August 2010
Actual Study Completion Date : January 2011

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Repigmentation of PA lesions measured by colorimetry [ Time Frame: 9 weeks ]
    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 :
  1. Change in transepidermal water loss of PA lesions [ Time Frame: 6 weeks ]
    Quantification of water loss measured by a evaporimeter in grams per squared meter per hour. Is an indirect measure of stratum corneum integrity.

  2. Investigator's repigmentation improvement [ Time Frame: 9 weeks ]
    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%).

  3. Reduction of the affected area by image analysis software [ Time Frame: 9 weeks ]
    ImageJ software will be used to measure the lesion reduction area after treatments

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   2 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01388517

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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"
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Study Chair: Juan P Castanedo-Cazares, MD Dermatology Department. Hospital Central "Dr. Ignacio Morones Prieto". San Luis Potosi, México
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Responsible Party: Juan Pablo Castanedo Cazares, Clinical Professor of dermatology, Universidad Autonoma de San Luis Potosí Identifier: NCT01388517    
Other Study ID Numbers: PA-CALTAC
First Posted: July 6, 2011    Key Record Dates
Last Update Posted: September 26, 2012
Last Verified: September 2012
Keywords provided by Juan Pablo Castanedo Cazares, Universidad Autonoma de San Luis Potosí:
Pityriasis alba
Additional relevant MeSH terms:
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Pityriasis Rosea
Skin Diseases, Papulosquamous
Skin Diseases
Scalp Dermatoses
Vitamin D
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Immunosuppressive Agents
Immunologic Factors
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Calcium Channel Agonists
Membrane Transport Modulators
Vasoconstrictor Agents
Dermatologic Agents