Atopic DermatitisPhase 3NCT04468711
Vitamin D in Egyptian Children With Atopic Dermatitis
A Phase 3 study testing Vitamin D in people with Atopic Dermatitis, run by National Hepatology & Tropical Medicine Research Institute at 1 site in Egypt.
Trial summary
There is an emergent evidence demonstrating the role of Vitamin D deficiency in eczema. Vitamin D supplementation with standard treatment yielded positive clinical outcomes for children and adolescents with mild and moderate AD; however, the potential benefit of vitamin D in severe cases remains unclear Read more about this study
- Who is it for?
- Ages 5 to 16 years
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- Vitamin D
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 92 participants
- Where
- 1 siteEgypt
- Study dates
- 6 Jun 2018to 4 Jun 2019
- Phase
- Phase 3
- 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 5 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 1.diagnosis of severe AD according to Hanifin and Rajka criteria and the Eczema Area and Severity Index (EASI) score
Who cannot join
- serious skin disorder other than AD.
- taking systemic corticosteroids or anti-inflammatory medications, prior vitamin D supplementation
- receiving oral or topical antibiotics or topical calcineurin inhibitors for at least one week prior to enrollment
- known gut absorption problem, presence of active skin infection at baseline any known hepatic and/or renal disease.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Impact of Vitamin D Supplementation as an Adjuvant Therapy on Clinical Outcome in Patients With Severe Atopic Dermatitis
There is an emergent evidence demonstrating the role of Vitamin D deficiency in eczema. Vitamin D supplementation with standard treatment yielded positive clinical outcomes for children and adolescents with mild and moderate AD; however, the potential benefit of vitamin D in severe cases remains unclear
- Conditions
- Atopic Dermatitis
- Being tested
- Vitamin D, Placebo
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin DDrug
Also called plus topical 1% hydrocortisone cream twice daily
Vitamin D plus topical 1% hydrocortisone cream twice daily
PlaceboDrug
placebo plus topical 1% hydrocortisone cream twice daily
| Study group | Role | What they receive |
|---|---|---|
| treatment group | Active comparator | vitamin D plus topical 1% hydrocortisone cream twice daily Receives: Drug: Vitamin D |
| placebo group | Placebo comparator | placebo plus plus topical 1% hydrocortisone cream twice daily Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
difference in the mean Eczema Area and Severity Index (EASI) score at the end of the study
Measured: 12 weeks
the average percent change in Eczema Area and Severity Index (EASI) score at the end of the study
Measured: 12 weeks
Secondary outcomes (3)
Difference in proportion of patients with a reduction from baseline of 75 % in Eczema Area and Severity Index (EASI) score
EASI 75
Measured: 12 weeks
Difference in proportion of patients with a reduction from baseline of (50 or more up to 75) in Eczema Area and Severity Index (EASI) score
EASI 50
Measured: 12 weeks
Difference in proportion of patients with a reduction from baseline of <50 n Eczema Area and Severity Index (EASI) score
EASI<50
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2020
- Study start6 Jun 2018
- Primary completion1 Dec 2018
- Study completion4 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic DermatitisStudies 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Hepatology & Tropical Medicine Research Institute
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Noha Mansour, National Hepatology & Tropical Medicine Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04468711
- Sponsor's protocol ID
- 12-2018
- Status last verified
- Jul 2020
- First submitted
- 9 Jul 2020
- Last updated
- 14 Jul 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Vitamin D Supplementation as an Adjuvant Therapy on Clinical Outcome in Patients With Severe Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT04468711
- Acronym / sponsor ID
- 12-2018
- Conditions
- Atopic Dermatitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- National Hepatology & Tropical Medicine Research InstituteOther government
- Study start
- 6 Jun 2018 (actual)
- Primary completion
- 1 Dec 2018 (actual)
- Study completion
- 4 Jun 2019 (actual)
- First posted
- 13 Jul 2020 (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.
There is an emergent evidence demonstrating the role of Vitamin D deficiency in eczema. Vitamin D supplementation with standard treatment yielded positive clinical outcomes for children and adolescents with mild and moderate AD; however, the potential benefit of vitamin D in severe cases remains unclear
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| treatment group | Active comparator | Drug: Vitamin Dvitamin D plus topical 1% hydrocortisone cream twice daily |
| placebo group | Placebo comparator | Drug: Placeboplacebo plus plus topical 1% hydrocortisone cream twice daily |
Who may qualify
- Ages
- 5 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 1.diagnosis of severe AD according to Hanifin and Rajka criteria and the Eczema Area and Severity Index (EASI) score
Key exclusion criteria (4 listed)
- serious skin disorder other than AD.
- taking systemic corticosteroids or anti-inflammatory medications, prior vitamin D supplementation
- receiving oral or topical antibiotics or topical calcineurin inhibitors for at least one week prior to enrollment
- known gut absorption problem, presence of active skin infection at baseline any known hepatic and/or renal disease.
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 |
|---|---|---|
| Vitamin DAlso: plus topical 1% hydrocortisone cream twice dailyVitamin D plus topical 1% hydrocortisone cream twice daily | Drug | treatment group |
| Placeboplacebo plus topical 1% hydrocortisone cream twice daily | Drug | placebo group |
Primary outcome
difference in the mean Eczema Area and Severity Index (EASI) score at the end of the study
Time frame: 12 weeks
the average percent change in Eczema Area and Severity Index (EASI) score at the end of the study
Time frame: 12 weeks
3 secondary outcomes
Difference in proportion of patients with a reduction from baseline of 75 % in Eczema Area and Severity Index (EASI) score
Time frame: 12 weeks
Difference in proportion of patients with a reduction from baseline of (50 or more up to 75) in Eczema Area and Severity Index (EASI) score
Time frame: 12 weeks
Difference in proportion of patients with a reduction from baseline of <50 n Eczema Area and Severity Index (EASI) score
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2020.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Vitamin D in people with Atopic Dermatitis, run by National Hepatology & Tropical Medicine Research Institute at 1 site in Egypt.
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 1 inclusion and 4 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 14 Jul 2020. 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 Egypt. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
difference in the mean Eczema Area and Severity Index (EASI) score at the end of the study (time frame: 12 weeks). 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?
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 14 Jul 2020.