HealthyPhase 1OCTNCT00655512
Comparison of Skin Thickness Under Treatment With Pimecrolimus 1% Cream, Hydrocortisonacetat 1% Cream, Betamethasonvalerat 0,1% Cream and Clobetasol-17-propionat 0,05% Cream Assessed by Optical Coherence Tomography (OCT) and 20-MHZ Ultrasound
A Phase 1 study testing pimecrolimus 1% cream, hydrocortisonacetat 1% cream and betamethasonvalerat 0,1% cream in people with Healthy, run by Technische Universität Dresden at 1 site in Germany.
Trial summary
to compare the atrophogenic potentials of pimecrolimus 1% cream, hydrocortisonacetat 1% cream, betamethasonvalerat 0,1% cream and clobetasol-17-Propionat 0,05% cream Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- pimecrolimus 1% cream, hydrocortisonacetat 1% cream and betamethasonvalerat 0,1% cream
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2008to Oct 2008
- 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 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- male and female probands age between 18-40 years
- skin healthy
- skintype I-III according to Fitzpatrick
Who cannot join
- women of childbearing potential without adequate contraception
- pregnant or breastfeeding
- genetic defect of epidermal barrier
- external or systemic treatment with drugs, which probably have an effect to the thickness of skin or to the production of teleangiektasien within the last 6 month before study entry
- skin disease, which hinder the evaluation with OCT, ultrasound or dermaphot
- UV treatment within the last 4 weeks before study entry
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- participation to another clinical trial within the last 30 days before study entry
- allergy against pimecrolimus or hydrocortison or betamethasonvalerat or Clobetasol-17-propionat
- severe systemic diseases; ongoing immunosuppressive treatment
- planned vaccination should realize before study entry or 28 days after end of treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Skin Thickness Under Treatment With Pimecrolimus 1% Cream (Elidel® 1% Cream), Hydrocortisonacetat 1% Cream (Hydrogalen® Cream), Betamethasonvalerat 0,1% Cream (Betagalen® Cream) and Clobetasol-17-propionat 0,05% Cream (Clobegalen® Cream) Assessed by Optical Coherence Tomography (OCT) and 20-MHZ Ultrasound - a Single Blind, Placebo-controlled, Randomized, Monocenter Clinical Trial
to compare the atrophogenic potentials of pimecrolimus 1% cream, hydrocortisonacetat 1% cream, betamethasonvalerat 0,1% cream and clobetasol-17-Propionat 0,05% cream
- Conditions
- Healthy
- Being tested
- pimecrolimus 1% cream, hydrocortisonacetat 1% cream, betamethasonvalerat 0,1% cream, clobetasol-17-propionat 0,05% cream, Placebo
- Keywords
- pimecrolimus, hydrocortison, betamethasone, clobetasol-17-Propionat, Optical Coherence Tomography, skin healthy probands
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pimecrolimus 1% creamDrug
Also called Elidel 1% cream
twice a day one fingertip at the testareas (forehead and forearm/back of the hand) for 4 weeks
hydrocortisonacetat 1% creamDrug
Also called Hydrogalen cream
twice a day one fingertip at the testareas (forehead and forearm/back of the hand) for 4 weeks
betamethasonvalerat 0,1% creamDrug
Also called Betagalen cream
twice a day one fingertip at the testareas (forearm/back of the hand) for 4 weeks
clobetasol-17-propionat 0,05% creamDrug
Also called Clobegalen cream
twice a day one fingertip at the testareas (forearm/back of the hand) for 4 weeks
PlaceboDrug
twice a day one fingertip at the testareas (forehead and forearm/back of the hand) for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Not described Receives: Drug: hydrocortisonacetat 1% cream; Drug: betamethasonvalerat 0,1% cream; Drug: clobetasol-17-propionat 0,05% cream |
| 2 | Active comparator | Not described Receives: Drug: pimecrolimus 1% cream; Drug: betamethasonvalerat 0,1% cream; Drug: clobetasol-17-propionat 0,05% cream |
| 3 | Active comparator | Not described Receives: Drug: pimecrolimus 1% cream; Drug: hydrocortisonacetat 1% cream; Drug: clobetasol-17-propionat 0,05% cream |
| 4 | Active comparator | Not described Receives: Drug: pimecrolimus 1% cream; Drug: hydrocortisonacetat 1% cream; Drug: betamethasonvalerat 0,1% cream |
| 5 | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
thickness of epidermis
Measured: 9 times in 4 weeks
Secondary outcomes (4)
atrophogenic effect assessed by dermaphot
Measured: 9 times in 4 weeks
moisture of skin assessed by corneometer
Measured: 9 times in 4 weeks
transpire of skin assessed by tewameter
Measured: 9 times in 4 weeks
thickness of dermis
Measured: 9 times in 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2008 (estimated)
- Study startJan 2008
- Primary completionJun 2008
- Study completionOct 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Technische Universität DresdenThe sponsor's other registered studies.
- 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Technische Universität Dresden
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Roland Aschoff, MD, Principal investigator, Department of Dermatology, Medical Faculty, Technical University Dresden, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00655512
- Sponsor's protocol ID
- TUD-OCT011-023
- Acronym
- OCT
- Status last verified
- Jun 2014
- First submitted
- 4 Apr 2008
- Last updated
- 11 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Skin Thickness Under Treatment With Pimecrolimus 1% Cream (Elidel® 1% Cream), Hydrocortisonacetat 1% Cream (Hydrogalen® Cream), Betamethasonvalerat 0,1% Cream (Betagalen® Cream) and Clobetasol-17-propionat 0,05% Cream (Clobegalen® Cream) Assessed by Optical Coherence Tomography (OCT) and 20-MHZ Ultrasound - a Single Blind, Placebo-controlled, Randomized, Monocenter Clinical Trial
- ClinicalTrials.gov ID
- NCT00655512
- Acronym / sponsor ID
- OCT / TUD-OCT011-023
- Conditions
- Healthy
- Keywords
- pimecrolimus, hydrocortison, betamethasone, clobetasol-17-Propionat, Optical Coherence Tomography, skin healthy probands
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Technische Universität DresdenUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Jun 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 10 Apr 2008 (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.
to compare the atrophogenic potentials of pimecrolimus 1% cream, hydrocortisonacetat 1% cream, betamethasonvalerat 0,1% cream and clobetasol-17-Propionat 0,05% cream
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: hydrocortisonacetat 1% cream, Drug: betamethasonvalerat 0,1% cream, Drug: clobetasol-17-propionat 0,05% cream |
| 2 | Active comparator | Drug: pimecrolimus 1% cream, Drug: betamethasonvalerat 0,1% cream, Drug: clobetasol-17-propionat 0,05% cream |
| 3 | Active comparator | Drug: pimecrolimus 1% cream, Drug: hydrocortisonacetat 1% cream, Drug: clobetasol-17-propionat 0,05% cream |
| 4 | Active comparator | Drug: pimecrolimus 1% cream, Drug: hydrocortisonacetat 1% cream, Drug: betamethasonvalerat 0,1% cream |
| 5 | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- male and female probands age between 18-40 years
- skin healthy
- skintype I-III according to Fitzpatrick
Key exclusion criteria (10 listed)
- women of childbearing potential without adequate contraception
- pregnant or breastfeeding
- genetic defect of epidermal barrier
- external or systemic treatment with drugs, which probably have an effect to the thickness of skin or to the production of teleangiektasien within the last 6 month before study entry
- skin disease, which hinder the evaluation with OCT, ultrasound or dermaphot
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 1% creamAlso: Elidel 1% creamtwice a day one fingertip at the testareas (forehead and forearm/back of the hand) for 4 weeks | Drug | 2, 3, 4 |
| hydrocortisonacetat 1% creamAlso: Hydrogalen creamtwice a day one fingertip at the testareas (forehead and forearm/back of the hand) for 4 weeks | Drug | 1, 3, 4 |
| betamethasonvalerat 0,1% creamAlso: Betagalen creamtwice a day one fingertip at the testareas (forearm/back of the hand) for 4 weeks | Drug | 1, 2, 4 |
| clobetasol-17-propionat 0,05% creamAlso: Clobegalen creamtwice a day one fingertip at the testareas (forearm/back of the hand) for 4 weeks | Drug | 1, 2, 3 |
| Placebotwice a day one fingertip at the testareas (forehead and forearm/back of the hand) for 4 weeks | Drug | 5 |
Primary outcome
thickness of epidermis
Time frame: 9 times in 4 weeks
4 secondary outcomes
atrophogenic effect assessed by dermaphot
Time frame: 9 times in 4 weeks
moisture of skin assessed by corneometer
Time frame: 9 times in 4 weeks
transpire of skin assessed by tewameter
Time frame: 9 times in 4 weeks
thickness of dermis
Time frame: 9 times in 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 11 Jun 2014.
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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.
Roland Aschoff, MD principal investigator
Department of Dermatology, Medical Faculty, Technical University Dresden, Germany
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 pimecrolimus 1% cream, hydrocortisonacetat 1% cream and betamethasonvalerat 0,1% cream in people with Healthy, run by Technische Universität Dresden 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 3 inclusion and 10 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 Jun 2014. 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?
thickness of epidermis (time frame: 9 times in 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 11 Jun 2014.