NCT03443765

Brief Summary

Pityriasis alba (PA) is a common, benign skin disorder occurring predominantly in children and adolescents. It is characterized by ill-defined hypopigmented macules and patches, round or oval in shape. They are most commonly located on the face (especially the cheeks), arms, and upper trunk; and they are more noticeable in people with darker skin types. Sun exposure accentuates the lesions. Patients and their parents are often anxious about the cosmetic appearance of the lesions. PA is not seasonal, although peeling may be worse in the winter (as a result of dry air in homes) and lesions may be more obvious in the spring and summer (as a result of sun exposure and darkening of the surrounding skin).No specific cause of PA has been identified. It is not contagious, and no infectious etiology has been reported. It is most common in individuals with a history of atopy, although it may occur in nonatopic individuals. In the present study, we will investigate the role of serum vitamin D levels and serum total IgE levels with development and course of PA. Plasma levels of 25(OH) vitamin D and Total serum immunoglobulin E will be determined by using ELISA technique.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
280

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2017

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

February 16, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 23, 2018

Completed
7.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

April 4, 2025

Status Verified

April 1, 2025

Enrollment Period

8.7 years

First QC Date

February 16, 2018

Last Update Submit

April 1, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • Serum 25(OH) vitamin D levels in the patients with pityriasis alba

    In this study we expect to determine a role of Vitamin D in the development and course of pityriasis alba

    up to 24 months

  • Total serum immunoglobulin E levels in the patients with pityriasis alba

    In this study we expect to determine a role of immunoglobulin E in the development and course of pityriasis alba

    up to 24 months

Study Arms (2)

Patients with Pityriasis alba

Diagnostic Test: Detection of Plasma levels of 25(OH) vitamin D by ELISA techniqueDiagnostic Test: Detection of Total serum immunoglobulin E by ELISA technique

Healthy participants (control group)

Diagnostic Test: Detection of Plasma levels of 25(OH) vitamin D by ELISA techniqueDiagnostic Test: Detection of Total serum immunoglobulin E by ELISA technique

Interventions

Five milliliters of peripheral venous blood sample will be taken (after 8-12 hours of fasting) from each participant and will be collected into HumaTube Serum Gel - C/A for ELISA. Serum will be appropriately obtained and stored at -20°C maximum of 30 days. Plasma levels of 25(OH) vitamin D will be detected by enzyme-linked immunosorbent assay (ELISA) technique.

Healthy participants (control group)Patients with Pityriasis alba

Five milliliters of peripheral venous blood sample will be taken (after 8-12 hours of fasting) from each participant and will be collected into HumaTube Serum Gel - C/A for ELISA. Serum will be appropriately obtained and stored at -20°C maximum of 30 days. Total serum immunoglobulin E will be detected by enzyme-linked immunosorbent assay (ELISA) technique.

Healthy participants (control group)Patients with Pityriasis alba

Eligibility Criteria

Age5 Years - 14 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

The prospective cohort study will be conducted on the basis of Research Institute of Epidemiology, Microbiology and Infectious Disease, Ministry of Public Health of the Republic of Uzbekistan. All participants will be residents of Uzbekistan. Diagnosis of pityriasis alba will be based on the results of clinical examination.

You may qualify if:

  • Patients with Pityriasis alba
  • Healthy individuals (control group)

You may not qualify if:

  • chronic and acute infectious diseases;
  • endocrine diseases;
  • congenital diseases;
  • allergic dermatitis;
  • bronchial asthma;
  • allergic rhinitis and/or conjunctivitis;
  • other skin disorders;
  • history of using vitamin D supplements within three months ago, or use of any medication influencing endocrine parameters.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research institute of epidemiology, microbiology and infectious diseases

Tashkent, Uchtepa, 100133, Uzbekistan

Location

Related Publications (1)

  • Toychiev A, Mirzoeva M, Davis N, Islamova J, Osipova S. Pityriasis alba: Possible associations with intestinal helminths and pathogenic protozoa. Int J Clin Pract. 2020 Feb;74(2):e13441. doi: 10.1111/ijcp.13441. Epub 2019 Oct 30.

    PMID: 31633268BACKGROUND

MeSH Terms

Conditions

Dandruff

Condition Hierarchy (Ancestors)

DermatitisSkin DiseasesSkin and Connective Tissue DiseasesScalp Dermatoses

Study Officials

  • Svetlana Osipova, MD, PhD, DS

    research institute of epidemiology, microbiology and infectious diseases

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 16, 2018

First Posted

February 23, 2018

Study Start

May 1, 2017

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

April 4, 2025

Record last verified: 2025-04

Locations