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Atopic DermatitisPhase 4NCT04900948

Prevention of Development of Transcutaneous Sensitization in Children With Atopic Dermatitis During Their First Year of Life

A Phase 4 study testing Pimecrolimus cream 1% and cream 0.1% methylprednisolone aceponate in people with Atopic Dermatitis, run by National Medical Research Center for Children's Health, Russian Federation at 1 site in Russia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This experimental non-randomized clinical study is aimed at comparing the efficacy and safety assessment of the proposed topical therapy algorithms with the use of topical calcineurin inhibitors in reducing the severity of atopic dermatitis and the degree of development of transcutaneous sensitization in children of… Read more about this study

Who is it for?
Ages 2 to 4 months
Conditions the study is for
Atopic Dermatitis
What is being tested?
Pimecrolimus cream 1% and cream 0.1% methylprednisolone aceponate
Could I receive a placebo?
No, everyone receives an active treatment
How many people
108 participants
Where
1 siteRussia
Study dates
10 Dec 2017to 25 Apr 2020
Phase
Phase 4
Are there results?
None posted in the registry

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 2 to 4 months
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • The severity of atopic dermatitis according to the EASI index (Eczema Area and Severity Index, index of prevalence and severity of eczema)> 7 points (moderate and / or severe course of atopic dermatitis);
  • A burdened family allergic history (at least one of the parents has atopic dermatitis, food allergy, bronchial asthma and / or allergic rhinitis);
  • The presence of sensitization in the child to one or more of the studied food and household allergens, determined at the screening stage by the ImmunoCAP method: cow's milk protein, chicken egg protein, wheat, soy, hx2 "house dust mixture: Dermatophagoides pteronyssinus, D. farinae, Blatella germanica ".

Who cannot join

  • Use of topical calcineurin inhibitors (pimecrolimus) in the last 30 days prior to inclusion in the study;
  • A history of concomitant severe neurological, endocrinological, cardiovascular, hepatic and renal diseases;
  • The presence of acute bacterial, viral infections;
  • The child's lack of sensitization to detectable food and household allergens;
  • Clinically significant changes in the general analysis of urine, general analysis of blood, biochemical analysis of blood;
  • Refusal to sign an informed consent to participate in the study;
  • Inability to observe the patient during the study.

Trial locations and contacts

1 site in 1 country.

Russia1 site

  • National Medical Research Center for Children's Health

    Moscow, 119296

Other trials in Russia

About this study

Official title: Prevention of Development of Transcutaneous Sensitization in Children With Atopic Dermatitis During Their First Year of Life: an Observational Study

This experimental non-randomized clinical study is aimed at comparing the efficacy and safety assessment of the proposed topical therapy algorithms with the use of topical calcineurin inhibitors in reducing the severity of atopic dermatitis and the degree of development of transcutaneous sensitization in children of the first year of life.

Read the detailed description

This experimental non-randomized clinical study is aimed at comparing the efficacy and safety assessment of the proposed topical therapy algorithms using topical glucocorticosteroids and topical calcineurin inhibitors in reducing the severity of atopic dermatitis and the degree of development of transcutaneous sensitization in children of the first year of life. The study included more than 100 children aged 2 to 4 months, who, depending on the decision of the researcher, were divided into two groups. During the period of acute manifestations / exacerbation of atopic dermatitis, patients of both groups received basic therapy, which included the use of a topical glucocorticosteroid (0.1% methylprednisolone aceponate cream) 2 times a day in combination with emollients 2 times a day for 10 days. After the relief of acute inflammatory manifestations, the patients were prescribed proactive therapy, including the use of a topical calcineurin inhibitor or a topical glucocorticosteroid, as a result of which comparison groups were formed. Group No. 1, after the end of basic therapy, received a topical calcineurin inhibitor (1% cream pimecrolimus), which was prescribed in the mode 2 times a day for 3 months, and then in the mode of double application (morning / evening) 3 times a week for up to 1 year. life; Group No. 2 after the end of basic therapy received a topical glucocorticosteroid (methylprednisolone aceponate 0.1%) 2 times a week for 3 months, and then - with exacerbation of AD. Patients of both groups used emollients for a long time in the mode 1-2 times a day. The safety and efficacy of the assigned algorithm was assessed by an investigator at the center. Efficacy was measured using the EASI (Eczema Area and Severity Index) score at screening and then at 6, 9 and 12 months of age. And also by tracking the dynamics of the class and level of sIgE to food (cow's milk protein, chicken egg protein, wheat, soy) and household (hx2 "house dust mixture: Dermatophagoides pteronyssinus, D. farinae, Blatella germanica") allergens using an automated immunological analyzer ImmunoCAP250 (UniCAP System / Phadia AB, Thermo Fisher Scientific, Sweden) at the time of screening and then at 6 and 12 months of age.

Being tested
Pimecrolimus cream 1%, cream 0.1% methylprednisolone aceponate
Keywords
Pimecrolimus, Methylprednisolone aceponate, Glucocorticoids, Calcineurin Inhibitors, Immunoglobulin E, Infant
Medical subject headings
Dermatitis, Atopic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Pimecrolimus cream 1%Drug

    Patients received pimecrolimus cream 1% 2 times a day for 3 months. Then use in a double application mode (morning / evening) 3 times a week for up to 1 year of age. Also, patients used emollients 1-2 times a day.

  • cream 0.1% methylprednisolone aceponateDrug

    Patients received 0.1% methylprednisolone aceponate cream 2 times a week for 3 months, and then used for exacerbation of atopic dermatitis. Also, patients used emollients 1-2 times a day.

Study groups in NCT04900948
Study groupRoleWhat they receive
Experimental group №1Experimentalproactive therapy with local calcineurin inhibitors + emollients
Receives: Drug: Pimecrolimus cream 1%
Experimental group №2Active comparatorproactive therapy with local glucocorticosteroids + emollients
Receives: Drug: cream 0.1% methylprednisolone aceponate

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from baseline response based on the specific IgE level at 6 months

    Assessment of change of specific IgE level for investigated food / household allergens in serum by ImmunoCAP

    Measured: 6 months of life

  2. Change from baseline response based on the specific IgE level at 12 months

    Assessment of change of specific IgE level for investigated food / household allergens in serum by ImmunoCAP

    Measured: 12 months of life

  3. Change from baseline response based on the class of sensitization at 6 months

    Assessment of change of the class of sensitization to food / household allergens by ImmunoCAP

    Measured: 6 months of life

  4. Change from baseline response based on the class of sensitization at 12 months

    Assessment of change of the class of sensitization to food / household allergens by ImmunoCAP

    Measured: 12 months of life

Secondary outcomes (2)

  1. Change in the Eczema Area and Severity Index (EASI) from baseline

    The Eczema Area and Severity Index (EASI) quantifies the severity of a subject's AD based on both severity of lesion clinical signs and the percent of body surface area (BSA) affected. EASI is a composite scoring of the degree of erythema, induration/papulation, excoriation, and lichenification (each scored separately) for each of four body regions, with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. Severity is classified as: 0 = clear; 0.1 - 1.0 = almost clear; 1.1-7.0 = mild; 7.1-21.0 = moderate; 21.1-50.0 = severe; 50.1-72.0 = very severe. The lower the scores the better outcome of the treatment.

    Measured: 6 months of age, 9 months of age, 12 months of age

  2. Incidence of Adverse events leading to discontinuation

    The number of participants who developed side effects that led to withdrawal from participation in the study. Registration of cases and reasons for the cancellation of the used external medicines.

    Measured: From Baseline up to 12 months of life

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 May 2021
  2. Study start10 Dec 2017
  3. Primary completion25 Apr 2020
  4. Study completion25 Apr 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Prevention
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
108 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04900948
Sponsor's protocol ID
13684925
Status last verified
May 2021
First submitted
17 May 2021
Last updated
27 May 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Murashkin NN, Namazova-Baranova LS, Makarova SG, Ivanov RA, Grigorev SG, Fedorov DV, Ambarchian ET, Epishev RV, Materikin AI, Opryatin LA, Savelova AA. Observational study of pimecrolimus 1% cream for prevention of transcutaneous sensitization in children with atopic dermatitis during their first year of life. Front Pediatr. 2023 Apr 25;11:1102354. doi: 10.3389/fped.2023.1102354. eCollection 2023.

    PubMed 37181420

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Pimecrolimus cream 1% and cream 0.1% methylprednisolone aceponate in people with Atopic Dermatitis, run by National Medical Research Center for Children's Health, Russian Federation at 1 site in Russia.

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 3 inclusion and 7 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: finished, as of the sponsor's last update on 27 May 2021. 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 Russia. 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Change from baseline response based on the specific IgE level at 6 months (time frame: 6 months of life). The study lists 4 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 NCT04900948, 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 27 May 2021.

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