Atopic DermatitisPhase 1NCT02376049
A Clinical Trial to Compare Topical Agents in Adults With Mild to Moderate Atopic Dermatitis (AD)
A Phase 1 study testing Pimecrolimus cream, Betamethasone dipropionate cream and Clobetasol propionate cream in people with Atopic Dermatitis, run by LEO Pharma at 2 sites in 2 countries.
Trial summary
An Explorative Clinical Trial to Evaluate an Intra Patient Comparison Design of Topical Agents in Adults with Mild to Moderate Atopic Dermatitis. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- Pimecrolimus cream, Betamethasone dipropionate cream and Clobetasol propionate cream
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Feb 2015to Jul 2015
- Phase
- Phase 1
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subject with mild to moderate AD
- Four comparable TAs
- TSS of at least 5 on all TAs
- Difference in TSS not greater than 2 between the TAs
- Sign score erythema ≥ 2 between the TAs
- TAs should be at least 2 cm apart
Who cannot join
- Investigator's opinion
- Fitzpatrick skin type >5
- Topical (i.e. on the TAs) treatment with prohibited medications
- Systemic treatment with prohibited medications
- Phototherapy within prohibited timeframe
- Use of emollients within prohibited timeframe
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: An Explorative Clinical Trial to Evaluate an Intra Patient Comparison Design of Topical Agents in Adults With Mild to Moderate Atopic Dermatitis
An Explorative Clinical Trial to Evaluate an Intra Patient Comparison Design of Topical Agents in Adults with Mild to Moderate Atopic Dermatitis.
Read the detailed description
Multi-center, prospective, randomized, vehicle-controlled, investigator-blinded, stable lesion design.
- Conditions
- Atopic Dermatitis
- Being tested
- Pimecrolimus cream, Betamethasone dipropionate cream, Clobetasol propionate cream, Glaxal Base cream vehicle
- Keywords
- Atopic Dermatitis, Eczema, AD
- 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.
Pimecrolimus creamDrug
Also called Elidel
Betamethasone dipropionate creamDrug
Also called Diprosone, Diprolene
Clobetasol propionate creamDrug
Also called Dermovate
Glaxal Base cream vehicleDrug
Also called emollient cream
| Study group | Role | What they receive |
|---|---|---|
| Pimecrolimus cream | Active comparator | Pimecrolimus 1% cream once daily for 14 days Receives: Drug: Pimecrolimus cream |
| Betamethasone dipropionate cream | Active comparator | Betamethasone dipropionate 0.05% cream once daily for 14 days Receives: Drug: Betamethasone dipropionate cream |
| Clobetasol propionate cream | Active comparator | Clobetasol propionate 0.05% cream once daily for 14 days Receives: Drug: Clobetasol propionate cream |
| Glaxal Base cream vehicle | Placebo comparator | Glaxal Base cream vehicle once daily for 14 days Receives: Drug: Glaxal Base cream vehicle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Sign Score (TSS) change
TSS change at end of treatment in relation to baseline
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2015 (estimated)
- Study startFeb 2015
- Primary completionJul 2015
- Study completionJul 2015
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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- LEO Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Emma Guttmann, MD, Principal investigator, Icahn School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02376049
- Sponsor's protocol ID
- EXP-1184
- Status last verified
- May 2017
- First submitted
- 25 Feb 2015
- Last updated
- 24 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Explorative Clinical Trial to Evaluate an Intra Patient Comparison Design of Topical Agents in Adults With Mild to Moderate Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT02376049
- Acronym / sponsor ID
- EXP-1184
- Conditions
- Atopic Dermatitis
- Keywords
- Atopic Dermatitis, Eczema, AD
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- LEO PharmaIndustry (pharma, biotech, devices)
- Study start
- Feb 2015
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 3 Mar 2015 (estimated)
- 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.
An Explorative Clinical Trial to Evaluate an Intra Patient Comparison Design of Topical Agents in Adults with Mild to Moderate Atopic Dermatitis.
Detailed description
Multi-center, prospective, randomized, vehicle-controlled, investigator-blinded, stable lesion design.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Pimecrolimus cream | Active comparator | Drug: Pimecrolimus creamPimecrolimus 1% cream once daily for 14 days |
| Betamethasone dipropionate cream | Active comparator | Drug: Betamethasone dipropionate creamBetamethasone dipropionate 0.05% cream once daily for 14 days |
| Clobetasol propionate cream | Active comparator | Drug: Clobetasol propionate creamClobetasol propionate 0.05% cream once daily for 14 days |
| Glaxal Base cream vehicle | Placebo comparator | Drug: Glaxal Base cream vehicleGlaxal Base cream vehicle once daily for 14 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subject with mild to moderate AD
- Four comparable TAs
- TSS of at least 5 on all TAs
- Difference in TSS not greater than 2 between the TAs
- Sign score erythema ≥ 2 between the TAs
Key exclusion criteria (6 listed)
- Investigator's opinion
- Fitzpatrick skin type >5
- Topical (i.e. on the TAs) treatment with prohibited medications
- Systemic treatment with prohibited medications
- Phototherapy within prohibited timeframe
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 |
|---|---|---|
| Pimecrolimus creamAlso: Elidel | Drug | Pimecrolimus cream |
| Betamethasone dipropionate creamAlso: Diprosone, Diprolene | Drug | Betamethasone dipropionate cream |
| Clobetasol propionate creamAlso: Dermovate | Drug | Clobetasol propionate cream |
| Glaxal Base cream vehicleAlso: emollient cream | Drug | Glaxal Base cream vehicle |
Primary outcome
Total Sign Score (TSS) change
Time frame: 14 days
TSS change at end of treatment in relation to baseline
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 24 Feb 2025.
- Clinical Trials at LEO PharmaLink provided by the sponsor.
- 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.
Emma Guttmann, MD principal investigator
Icahn School of Medicine
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Pimecrolimus cream, Betamethasone dipropionate cream and Clobetasol propionate cream in people with Atopic Dermatitis, run by LEO Pharma at 2 sites in 2 countries.
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 6 inclusion and 6 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 24 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada, 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Total Sign Score (TSS) change (time frame: 14 days). 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 24 Feb 2025.