Atopic DermatitisPhase 2NCT05276323
Medihoney® Derma Cream Treatment for Mild to Moderate Atopic Dermatitis in Children Study
A Phase 2 study testing Medihoney Derma Cream and Hydrocortisone 1% cream in people with Atopic Dermatitis, run by Soroka University Medical Center at 1 site in Israel.
Trial summary
A randomized, open-label trial comparing Medihoney Derma Cream to Hydrocortisone 1% cream. Children between the ages of 2-18 years old diagnosed with mild to moderate atopic dermatitis with an IGA (Investigator Global Assessment) score of 2-3, and a BSA (Body Surface Area) score of 1%-10% were included. Read more about this study
- Who is it for?
- Ages 2 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- Medihoney Derma Cream and Hydrocortisone 1% cream
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Oct 2020to 31 Dec 2021
- Phase
- Phase 2
- 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 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 2-18 years old
- mild to moderate atopic dermatitis
- an IGA score of 2-3
- BSA score of 1%-10%.
Who cannot join
- participation in any clinical trial less than 28 days before the enrollment
- AD-related systemic therapy or phototherapy within 28 days prior to the enrollment
- topical corticosteroids, calcineurin inhibitors, or PDE4 inhibitors use within 7 days prior to the enrollment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Medihoney® Derma Cream Treatment for Mild to Moderate Atopic Dermatitis in Children: an Open-label Randomized Pilot Study
A randomized, open-label trial comparing Medihoney Derma Cream to Hydrocortisone 1% cream. Children between the ages of 2-18 years old diagnosed with mild to moderate atopic dermatitis with an IGA (Investigator Global Assessment) score of 2-3, and a BSA (Body Surface Area) score of 1%-10% were included.
Read the detailed description
A randomized trial comprising children aged 2-18 diagnosed with mild to moderate AD, with an IGA of 2-3 and BSA of 1%-10%, including 30 patients, 20 using Med-D-Cream and 10 as controls using Hydrocortisone 1% cream. Patients applied creams for 2 weeks and were then followed for two weeks to measure clinical responses and pruritus change.
- Conditions
- Atopic Dermatitis
- Being tested
- Medihoney Derma Cream, Hydrocortisone 1% cream
- Keywords
- eczema, atopic dermatitis, Medihoney dermacream
- Medical subject headings
- Dermatitis, Atopic, Eczema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medihoney Derma CreamDrug
applied topically, twice a day, on all affected areas in the body for two weeks.
Hydrocortisone 1% creamDrug
applied topically, twice a day, on all affected areas in the body for two weeks.
| Study group | Role | What they receive |
|---|---|---|
| Medihoney Derma Cream | Experimental | Intervention group: Medihoney Derma Cream will be applied topically, twice a day, on all affected areas in the body for two weeks. Then, follow-up for two more weeks, overall participating for 4 weeks in the trial. Receives: Drug: Medihoney Derma Cream |
| Hydrocortisone 1% cream | Active comparator | control group: Hydrocortisone 1% cream will be applied topically, twice a day, on all affected areas in the body for two weeks. Then, follow-up for two more weeks, overall participating for 4 weeks in the trial. Receives: Drug: Hydrocortisone 1% cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
response rate
This study's primary outcome was defined as an IGA (Investigator Global Assessment) severity score of 0 or 1 with at least 1-grade reduction at visit 3. score range 0-4 (4 worse symptomes)
Measured: 1 month
Secondary outcomes (3)
VAS (Visual Analogue Scale) pruritis score
score range is 1 to 10. 1:no itch, 10:very itchy
Measured: 1 month
SCORAD - (SCORing Atopic Dermatitis)
SCORAD is a clinical tool used to assess the extent and severity of eczema. range 0-103. 103- worse eczema
Measured: 2 weeks
The Eczema Area and Severity Index (EASI)
is a validated scoring system that grades the physical signs of atopic dermatitis/eczema. The minimum EASI score is 0 and the maximum EASI score is 72 (72 worse eczema)
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2022
- Study start1 Oct 2020
- Primary completion28 Feb 2021
- Study completion31 Dec 2021
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- We conducted a randomized trial comprising children aged 2-18 diagnosed with mild to moderate AD, with an IGA of 2-3 and BSA of 1%-10%, including 30 patients, 20 using Med-D-Cream and 10 as controls using Hydrocortisone 1% cream. Patients applied creams for 2 weeks and were then followed for two weeks to measure clinical responses.
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Soroka University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, AMIR HOREV, Soroka University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05276323
- Sponsor's protocol ID
- SorokaUMC
- Status last verified
- Mar 2022
- First submitted
- 20 Feb 2022
- Last updated
- 11 Mar 2022
- 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 11 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medihoney® Derma Cream Treatment for Mild to Moderate Atopic Dermatitis in Children: an Open-label Randomized Pilot Study
- ClinicalTrials.gov ID
- NCT05276323
- Acronym / sponsor ID
- SorokaUMC
- Conditions
- Atopic Dermatitis
- Keywords
- eczema, atopic dermatitis, Medihoney dermacream
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Soroka University Medical CenterUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 28 Feb 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 11 Mar 2022 (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.
A randomized, open-label trial comparing Medihoney Derma Cream to Hydrocortisone 1% cream. Children between the ages of 2-18 years old diagnosed with mild to moderate atopic dermatitis with an IGA (Investigator Global Assessment) score of 2-3, and a BSA (Body Surface Area) score of 1%-10% were included.
Detailed description
A randomized trial comprising children aged 2-18 diagnosed with mild to moderate AD, with an IGA of 2-3 and BSA of 1%-10%, including 30 patients, 20 using Med-D-Cream and 10 as controls using Hydrocortisone 1% cream. Patients applied creams for 2 weeks and were then followed for two weeks to measure clinical responses and pruritus change.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- We conducted a randomized trial comprising children aged 2-18 diagnosed with mild to moderate AD, with an IGA of 2-3 and BSA of 1%-10%, including 30 patients, 20 using Med-D-Cream and 10 as controls using Hydrocortisone 1% cream. Patients applied creams for 2 weeks and were then followed for two weeks to measure clinical responses.
| Arm | Type | Receives |
|---|---|---|
| Medihoney Derma Cream | Experimental | Drug: Medihoney Derma CreamIntervention group: Medihoney Derma Cream will be applied topically, twice a day, on all affected areas in the body for two weeks. Then, follow-up for two more weeks, overall participating for 4 weeks in the trial. |
| Hydrocortisone 1% cream | Active comparator | Drug: Hydrocortisone 1% creamcontrol group: Hydrocortisone 1% cream will be applied topically, twice a day, on all affected areas in the body for two weeks. Then, follow-up for two more weeks, overall participating for 4 weeks in the trial. |
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 2-18 years old
- mild to moderate atopic dermatitis
- an IGA score of 2-3
- BSA score of 1%-10%.
Key exclusion criteria (3 listed)
- participation in any clinical trial less than 28 days before the enrollment
- AD-related systemic therapy or phototherapy within 28 days prior to the enrollment
- topical corticosteroids, calcineurin inhibitors, or PDE4 inhibitors use within 7 days prior to the enrollment
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 |
|---|---|---|
| Medihoney Derma Creamapplied topically, twice a day, on all affected areas in the body for two weeks. | Drug | Medihoney Derma Cream |
| Hydrocortisone 1% creamapplied topically, twice a day, on all affected areas in the body for two weeks. | Drug | Hydrocortisone 1% cream |
Primary outcome
response rate
Time frame: 1 month
This study's primary outcome was defined as an IGA (Investigator Global Assessment) severity score of 0 or 1 with at least 1-grade reduction at visit 3. score range 0-4 (4 worse symptomes)
3 secondary outcomes
VAS (Visual Analogue Scale) pruritis score
Time frame: 1 month
SCORAD - (SCORing Atopic Dermatitis)
Time frame: 2 weeks
The Eczema Area and Severity Index (EASI)
Time frame: 2 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 11 Mar 2022.
- Individual participant dataSharing planned: No
Related trials for Atopic Dermatitis
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
RecruitingObservational study
Blood, Urine, and Tissue Collection for Cutaneous Lymphoma, Eczema, and Atopic Dermatitis Research
Cutaneous T-cell Lymphoma, Sezary Syndrome
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Not yet recruitingPhase 1
A Study of HSK60002 Tablets in Participants With Moderate-to-Severe Atopic Dermatitis
Dermatitis Atopic
RecruitingPhase 3
A Study to Learn About the Study Medicine Called Tilrekimig in People With Moderate-to Severe Eczema
Atopic Dermatitis
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 2 study testing Medihoney Derma Cream and Hydrocortisone 1% cream in people with Atopic Dermatitis, run by Soroka University Medical Center at 1 site in Israel.
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 4 inclusion and 3 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 11 Mar 2022. 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 Israel. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
response rate (time frame: 1 month). 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 11 Mar 2022.