Clinical Trial of 0.0003% Calcitriol, 0.1% Tacrolimus, and Petrolatum for the Treatment of Pityriasis Alba
Condition: Pityriasis Alba
MeSH terms: Pityriasis; Pityriasis Rosea; Dandruff
Study type: Interventional
Phase: Phase 4

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.
    

Intervention name(s): Tacrolimus; Calcitriol; Petrolatum
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 0.1% tacrolimus ointment to apply twice a day for 9 weeks on pytiriasis alba plaques.; 0.0003% calcitriol ointment to apply twice a day for 9 weeks on pytiriasis alba plaques.; Petrolatum ointment to apply twice a day for 9 weeks on pytiriasis alba plaques.
Other intervention name(s): Protopic; FK506 ointment; Silkis; Topical Vitamin D analogs; Vaseline; Acuaphore
Intervention MeSH terms: Vitamin D; Calcitriol; Petrolatum; Tacrolimus
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Pityriasis alba; Tacrolimus; Calcitriol; Petrolatum