Skin Tissue DiseasesPhase 1NCT02392130
A Clinical Trial to Assess the Potential of LEO 130852A Gel to Reduce Steroid Induced Skin Atrophy on Healthy Skin
A Phase 1 study testing Clobetasol propionate 0.05% ointment and LEO 130852A gel 1% in people with Skin Tissue Diseases and Connective Tissue Diseases, run by LEO Pharma at 1 site in Germany.
Trial summary
The purpose of this study is to assess the effect of LEO 130852A gel 1% in maintaining skin thickness in healthy skin treated with steroid. Read more about this study
- Who is it for?
- Ages 25 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Skin Tissue Diseases, Connective Tissue Diseases
- What is being tested?
- Clobetasol propionate 0.05% ointment and LEO 130852A gel 1%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2015to Jun 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 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male volunteers, 25 to 50 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.
About this study
Official title: A Prospective, Randomised, Investigator-Blinded, Vehicle-Controlled, Phase I Clinical Trial With Intra-Individual Comparison of Treatments to Assess the Potential of LEO 130852A Gel to Reduce Steroid Induced Skin Atrophy on Healthy Skin
The purpose of this study is to assess the effect of LEO 130852A gel 1% in maintaining skin thickness in healthy skin treated with steroid.
- Conditions
- Skin Tissue Diseases, Connective Tissue Diseases
- Being tested
- Clobetasol propionate 0.05% ointment, LEO 130852A gel 1%, LEO 130852A placebo gel
- Medical subject headings
- 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
LEO 130852A gel 1%Drug
LEO 130852A placebo gelDrug
| Study group | Role | What they receive |
|---|---|---|
| Active Drug | Active comparator | Clobetasol propionate 0.05% ointment Receives: Drug: Clobetasol propionate 0.05% ointment |
| Experimental Drug | Experimental | LEO 130852A gel 1% Receives: Drug: LEO 130852A gel 1% |
| Placebo Drug | Placebo comparator | LEO 130852A placebo gel Receives: Drug: LEO 130852A placebo gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skin thickness measured by sonography and histology
Measured: 4 weeks
Secondary outcomes (2)
Clinical assessments measured by atrophy score
Measured: 4 weeks
Clinical assessments measured by telangiectasia score
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 posted18 Mar 2015 (estimated)
- Study startMar 2015
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin 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
- 40 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
- NCT02392130
- Sponsor's protocol ID
- SKAT-1129
- Status last verified
- May 2017
- First submitted
- 6 Mar 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 Prospective, Randomised, Investigator-Blinded, Vehicle-Controlled, Phase I Clinical Trial With Intra-Individual Comparison of Treatments to Assess the Potential of LEO 130852A Gel to Reduce Steroid Induced Skin Atrophy on Healthy Skin
- ClinicalTrials.gov ID
- NCT02392130
- Acronym / sponsor ID
- SKAT-1129
- Conditions
- Skin Tissue Diseases, Connective Tissue Diseases
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- LEO PharmaIndustry (pharma, biotech, devices)
- Study start
- Mar 2015
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 18 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.
The purpose of this study is to assess the effect of LEO 130852A gel 1% in maintaining skin thickness in healthy skin treated with steroid.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Active Drug | Active comparator | Drug: Clobetasol propionate 0.05% ointmentClobetasol propionate 0.05% ointment |
| Experimental Drug | Experimental | Drug: LEO 130852A gel 1%LEO 130852A gel 1% |
| Placebo Drug | Placebo comparator | Drug: LEO 130852A placebo gelLEO 130852A placebo gel |
Who may qualify
- Ages
- 25 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy male volunteers, 25 to 50 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 | Active Drug |
| LEO 130852A gel 1% | Drug | Experimental Drug |
| LEO 130852A placebo gel | Drug | Placebo Drug |
Primary outcome
Skin thickness measured by sonography and histology
Time frame: 4 weeks
2 secondary outcomes
Clinical assessments measured by atrophy score
Time frame: 4 weeks
Clinical assessments measured by telangiectasia score
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 and LEO 130852A gel 1% in people with Skin Tissue Diseases 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?
Skin thickness measured by sonography and histology (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.