Skin and Connective Tissue DiseasesPhase 1NCT02355639
A Single-Centre Clinical Trial to Assess Steroid Induced Skin Atrophy on Healthy Skin
A Phase 1 study testing Clobetasol propionate 0.05 % ointment, Betamethasone dipropionate 0.064 % ointment and Petrolatum ointment in people with Skin and Connective Tissue Diseases, run by LEO Pharma at 1 site in Germany.
Trial summary
The purpose of this study is to assess steroid induced skin atrophy by sonography. Read more about this study
- Who is it for?
- Ages 25 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Skin and Connective Tissue Diseases
- What is being tested?
- Clobetasol propionate 0.05 % ointment, Betamethasone dipropionate 0.064 % ointment and Petrolatum ointment
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2015to Apr 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 25 to 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male volunteers, 25 to 40 years old inclusive.
- Healthy skin on volar arms with a hairless area sufficient for measurements
Who cannot join
- Clinical skin atrophy, telangiectasia or striae on volar arms.
- Presence of any skin condition or colouration that would interfere with test sites or the response or assessment.
- Fitzpatrick skin type IV - VI.
- History or current evidence of infection, eczema or other relevant skin disease.
Trial locations and contacts
1 site in 1 country.
Germany1 site
Charité - Universitaetsmedizin Berlin, Department of Dermatology and Allergy
Berlin, 10117
About this study
Official title: A Single-Centre, Explorative, Randomised, Investigator-Blinded, Negative-Controlled, Phase I Clinical Trial With Intra-Individual Comparison of Treatments to Assess Steroid Induced Skin Atrophy on Healthy Skin
The purpose of this study is to assess steroid induced skin atrophy by sonography.
- Conditions
- Skin and Connective Tissue Diseases
- Being tested
- Clobetasol propionate 0.05 % ointment, Betamethasone dipropionate 0.064 % ointment, Petrolatum ointment
- Medical subject headings
- Skin and Connective Tissue Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clobetasol propionate 0.05 % ointmentDrug
Betamethasone dipropionate 0.064 % ointmentDrug
Petrolatum ointmentDrug
| Study group | Role | What they receive |
|---|---|---|
| Clobetasol propionate 0.05 % ointment | Experimental | Active drug Receives: Drug: Clobetasol propionate 0.05 % ointment |
| Betamethasone dipropionate 0.064 % ointment | Experimental | Active drug Receives: Drug: Betamethasone dipropionate 0.064 % ointment |
| Petrolatum ointment | Placebo comparator | Placebo drug Receives: Drug: Petrolatum ointment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in skin thickness from baseline to end of treatment
Measured: 4 weeks
Secondary outcomes (1)
Relation of clinical features (skin transparency and telangiectasia) to the steroid induced skin atrophy after end of treatment
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2015 (estimated)
- Study startJan 2015
- Primary completionApr 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin and Connective Tissue DiseasesStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- LEO Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02355639
- Sponsor's protocol ID
- EXP-1090
- Status last verified
- May 2017
- First submitted
- 27 Jan 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
- A Single-Centre, Explorative, Randomised, Investigator-Blinded, Negative-Controlled, Phase I Clinical Trial With Intra-Individual Comparison of Treatments to Assess Steroid Induced Skin Atrophy on Healthy Skin
- ClinicalTrials.gov ID
- NCT02355639
- Acronym / sponsor ID
- EXP-1090
- Conditions
- Skin and Connective Tissue Diseases
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- LEO PharmaIndustry (pharma, biotech, devices)
- Study start
- Jan 2015
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 4 Feb 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.
The purpose of this study is to assess steroid induced skin atrophy by sonography.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Clobetasol propionate 0.05 % ointment | Experimental | Drug: Clobetasol propionate 0.05 % ointmentActive drug |
| Betamethasone dipropionate 0.064 % ointment | Experimental | Drug: Betamethasone dipropionate 0.064 % ointmentActive drug |
| Petrolatum ointment | Placebo comparator | Drug: Petrolatum ointmentPlacebo drug |
Who may qualify
- Ages
- 25 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy male volunteers, 25 to 40 years old inclusive.
- Healthy skin on volar arms with a hairless area sufficient for measurements
Key exclusion criteria (4 listed)
- Clinical skin atrophy, telangiectasia or striae on volar arms.
- Presence of any skin condition or colouration that would interfere with test sites or the response or assessment.
- Fitzpatrick skin type IV - VI.
- History or current evidence of infection, eczema or other relevant skin 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 |
|---|---|---|
| Clobetasol propionate 0.05 % ointment | Drug | Clobetasol propionate 0.05 % ointment |
| Betamethasone dipropionate 0.064 % ointment | Drug | Betamethasone dipropionate 0.064 % ointment |
| Petrolatum ointment | Drug | Petrolatum ointment |
Primary outcome
Change in skin thickness from baseline to end of treatment
Time frame: 4 weeks
1 secondary outcome
Relation of clinical features (skin transparency and telangiectasia) to the steroid induced skin atrophy after end of treatment
Time frame: 4 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 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.
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 1 study testing Clobetasol propionate 0.05 % ointment, Betamethasone dipropionate 0.064 % ointment and Petrolatum ointment in people with Skin and Connective Tissue Diseases, run by LEO Pharma at 1 site in Germany.
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 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 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 1 site in Germany. 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?
Change in skin thickness from baseline to end of treatment (time frame: 4 weeks). 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.