Pityriasis AlbaNCT03443765
Serum 25(OH) Vitamin D and Total Serum Immunoglobulin E Levels in Patients With Pityriasis Alba
An observational study of Pityriasis Alba, run by Research Institute of Epidemiology, Microbiology and Infectious Diseases, Uzbekistan at 1 site in Uzbekistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Pityriasis Alba
- What is being tested?
- Detection of Plasma levels of 25(OH) vitamin D by ELISA technique and Detection of Total serum immunoglobulin E by ELISA technique
- How many people
- 280 participants
- Where
- 1 siteUzbekistan
- Study dates
- 1 May 2017to 31 Dec 2025
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
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.
Who may be able to join
- Patients with Pityriasis alba
- Healthy individuals (control group)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Uzbekistan1 site
Research institute of epidemiology, microbiology and infectious diseases
Tashkent, Uchtepa, 100133
About this study
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.
Read the detailed description
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.
Both informed and written consents will be obtained from the parents or from appropriate relative or guardian of the patients and healthy individuals of the control group.
Study participants will be included about 30 children aged 5 to 12 years with pityriasis alba. The control group will be included about 20 healthy individuals. All the participants will be residents of Uzbekistan.
Diagnosis of pityriasis alba Diagnosis of pityriasis alba will be based on the results of clinical examination. Inclusion criteria: revealing multiple round or oval-shaped hypopigmented macules or patches with indistinct margins. A weak erythema may be observed in some patches. The lesions number could varied from four to ten, 0.5 cm - 5 cm in size, and they are distributed predominantly on the face, neck, upper arms, and upper trunk.
Exclusion criteria The exclusion criteria: 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.
Measurement of anthropometric indices Demographic data will be obtained in the survey included age, gender, and body mass index (BMI) calculated as weight (kg)/height2 (m2).
Sample Collection and Storage 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. All blood samples will be collected during summer period.
Estimation of Vitamin D and Total Immunoglobulin E Plasma levels of 25(OH) vitamin D (DIAsource kit, Belgium) and Total serum immunoglobulin E (HUMAN kit, Germany) will be determined using ELISA technique.
Classification of Vitamin D and Total Immunoglobulin E Serum vitamin D level will be classified as reported by Holick (Holick MF. 2007). Levels of vitamin D ≤20, 21-29, ≥30-150, and >150 ng/ml will be considered as vitamin D deficiency, vitamin D insufficiency, vitamin D sufficiency and vitamin D intoxication, respectively.
Normal levels of total immunoglobulin E for children 1-6 years old - <30 Ul/ml, 7-9 years old - <60 Ul/ml and 10-12 years old - <100 Ul/ml, 13-16 years old - <150 Ul/ml.
- Conditions
- Pityriasis Alba
- Being tested
- Detection of Plasma levels of 25(OH) vitamin D by ELISA technique, Detection of Total serum immunoglobulin E by ELISA technique
- Medical subject headings
- Dandruff
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Detection of Plasma levels of 25(OH) vitamin D by ELISA techniqueDiagnostic test
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.
Detection of Total serum immunoglobulin E by ELISA techniqueDiagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| Patients with Pityriasis alba | Not described Receives: Diagnostic Test: Detection of Plasma levels of 25(OH) vitamin D by ELISA technique; Diagnostic Test: Detection of Total serum immunoglobulin E by ELISA technique | |
| Healthy participants (control group) | Not described Receives: Diagnostic Test: Detection of Plasma levels of 25(OH) vitamin D by ELISA technique; Diagnostic Test: Detection of Total serum immunoglobulin E by ELISA technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2018
- Study start1 May 2017
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pityriasis AlbaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 280 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Research Institute of Epidemiology, Microbiology and Infectious Diseases, Uzbekistan
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Svetlana Osipova, MD, PhD, DS, Research Institute of Epidemiology, Microbiology and Infectious Diseases, Uzbekistan
- Investigators
- Svetlana Osipova, MD, PhD, DS, Principal investigator, research institute of epidemiology, microbiology and infectious diseases
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03443765
- Sponsor's protocol ID
- Project #002
- Status last verified
- Apr 2025
- First submitted
- 16 Feb 2018
- Last updated
- 4 Apr 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 31633268
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serum 25(OH) Vitamin D and Total Serum Immunoglobulin E Levels in Patients With Pityriasis Alba
- ClinicalTrials.gov ID
- NCT03443765
- Acronym / sponsor ID
- Project #002
- Conditions
- Pityriasis Alba
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 280 participants (estimated)
- Lead sponsor
- Research Institute of Epidemiology, Microbiology and Infectious Diseases, UzbekistanOther government
- Study start
- 1 May 2017 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 23 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Both informed and written consents will be obtained from the parents or from appropriate relative or guardian of the patients and healthy individuals of the control group.
Study participants will be included about 30 children aged 5 to 12 years with pityriasis alba. The control group will be included about 20 healthy individuals. All the participants will be residents of Uzbekistan.
Diagnosis of pityriasis alba Diagnosis of pityriasis alba will be based on the results of clinical examination. Inclusion criteria: revealing multiple round or oval-shaped hypopigmented macules or patches with indistinct margins. A weak erythema may be observed in some patches. The lesions number could varied from four to ten, 0.5 cm - 5 cm in size, and they are distributed predominantly on the face, neck, upper arms, and upper trunk.
Exclusion criteria The exclusion criteria: 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.
Measurement of anthropometric indices Demographic data will be obtained in the survey included age, gender, and body mass index (BMI) calculated as weight (kg)/height2 (m2).
Sample Collection and Storage 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. All blood samples will be collected during summer period.
Estimation of Vitamin D and Total Immunoglobulin E Plasma levels of 25(OH) vitamin D (DIAsource kit, Belgium) and Total serum immunoglobulin E (HUMAN kit, Germany) will be determined using ELISA technique.
Classification of Vitamin D and Total Immunoglobulin E Serum vitamin D level will be classified as reported by Holick (Holick MF. 2007). Levels of vitamin D ≤20, 21-29, ≥30-150, and >150 ng/ml will be considered as vitamin D deficiency, vitamin D insufficiency, vitamin D sufficiency and vitamin D intoxication, respectively.
Normal levels of total immunoglobulin E for children 1-6 years old - <30 Ul/ml, 7-9 years old - <60 Ul/ml and 10-12 years old - <100 Ul/ml, 13-16 years old - <150 Ul/ml.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with Pityriasis alba | – | Diagnostic Test: Detection of Plasma levels of 25(OH) vitamin D by ELISA technique, Diagnostic 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 technique, Diagnostic Test: Detection of Total serum immunoglobulin E by ELISA technique |
Who may qualify
- Ages
- 5 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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.
Key inclusion criteria (2 listed)
- Patients with Pityriasis alba
- Healthy individuals (control group)
Key exclusion criteria (8 listed)
- chronic and acute infectious diseases;
- endocrine diseases;
- congenital diseases;
- allergic dermatitis;
- bronchial asthma;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Detection of Plasma levels of 25(OH) vitamin D by ELISA techniqueFive 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. | Diagnostic test | Healthy participants (control group), Patients with Pityriasis alba |
| Detection of Total serum immunoglobulin E by ELISA techniqueFive 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. | Diagnostic test | Healthy participants (control group), Patients with Pityriasis alba |
Primary outcome
Serum 25(OH) vitamin D levels in the patients with pityriasis alba
Time frame: up to 24 months
In this study we expect to determine a role of Vitamin D in the development and course of pityriasis alba
Total serum immunoglobulin E levels in the patients with pityriasis alba
Time frame: up to 24 months
In this study we expect to determine a role of immunoglobulin E in the development and course of pityriasis alba
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2025.
- Results publication: PubMed 31633268Toychiev 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Svetlana Osipova, MD, PhD, DS principal investigator
research institute of epidemiology, microbiology and infectious diseases
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pityriasis Alba, run by Research Institute of Epidemiology, Microbiology and Infectious Diseases, Uzbekistan at 1 site in Uzbekistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 4 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Uzbekistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum 25(OH) vitamin D levels in the patients with pityriasis alba (time frame: up to 24 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03443765, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2025.