Cutaneous InflammationPhase 1NCT00719121
Study on Anti-inflammatory Effects of Topical R115866 Gel
A Phase 1 study testing Talarozole and Differin™, 0.1% adapalene gel in people with Cutaneous Inflammation, run by Stiefel, a GSK Company at 1 site in Belgium.
Trial summary
The purpose of this exploratory trial is to assess the anti-inflammatory effect(s) of topical R115866 in a model of UVB-induced inflammation and in a model of cutaneous irritation. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Cutaneous Inflammation
- What is being tested?
- Talarozole and Differin™, 0.1% adapalene gel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteBelgium
- Study dates
- Nov 2006to Mar 2007
- 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 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Body Mass Index should be between 18 and 28 kg/m2
- Subjects are healthy as determined by medical history, physical examination and clinical laboratory tests carried out at screening
- Subjects with a phototype III or IV (according to Fitzpatrick classification)
Who cannot join
- Subjects with history of or active alcohol or substance abuse problems.
- Known hypersensitivity to azoles, adapalene, retinoids or any other ingredient of the gels
- Subjects who have a laboratory value which, in the opinion of the investigator, is clinically-relevant out of the normal range
- Subjects with clinically relevant abnormal ECG-intervals or morphology of the ECG, QTc interval >450 ms
- Use of vitamin A (>1000 µg/day) or the use of concomitant medication, except paracetamol; All other medication must have been stopped at least 14 days before the first administration of gel)
- Subjects who have received an investigational product which is not a biological within the month preceding the screening visit; If the investigational product is a biological, a 3-month wash-out period is required.
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- Use of ultraviolet light (including artificial UVA and UVB as well as excessive natural sun exposure) unless stopped at Visit 1
- Subjects judged by the investigator to have a high probability of lack of compliance with the provisions of the protocol
- Subjects having any medical condition which, in the opinion of the investigator at the site, is a contraindication to enrollment
Trial locations and contacts
1 site in 1 country.
Belgium1 site
Department of DermatopathologyCentre Hospitalier Universitaire du Sart Tilman
Liège, B-4000
About this study
Official title: Placebo-Controlled, Investigator Blinded, Explorative Trial to Evaluate the Anti-inflammatory Effect of Multiple Topical Applications of R115866 Gel (0.35%) in Two Models of Cutaneous Inflammation in Healthy Male Subjects
The purpose of this exploratory trial is to assess the anti-inflammatory effect(s) of topical R115866 in a model of UVB-induced inflammation and in a model of cutaneous irritation.
- Conditions
- Cutaneous Inflammation
- Being tested
- Talarozole, Differin™, 0.1% adapalene gel
- Medical subject headings
- Dermatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TalarozoleDrug
Also called Rambazole, R115866
Topical Application (20 mg)
Differin™, 0.1% adapalene gelDrug
Also called adapalene gel
Topical Application (20 mg)
| Study group | Role | What they receive |
|---|---|---|
| A | No intervention | No Treatment |
| B | Active comparator | R115866 (0.35% gel) Receives: Drug: Talarozole |
| C | Active comparator | R115866 Vehicle gel Receives: Drug: Talarozole |
| D | Active comparator | Differin™, 0.1% adapalene gel Receives: Drug: Differin™, 0.1% adapalene gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary efficacy endpoint was the mean value of TEWL (Trans-epidermal water loss)
Measured: Day 1 through Day 9 of treatment
Secondary outcomes (1)
Erythema
Measured: Day 1 through Day 8 of treatment and Day 15 post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2008 (estimated)
- Study startNov 2006
- Primary completionDec 2006
- Study completionMar 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cutaneous InflammationStudies 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
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stiefel, a GSK Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Prof. Dr. G. Piérard, MD, PhD, Principal investigator, Department of Dermatopathology Centre Hospitalier Universitaire du Sart-Tilman
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00719121
- Sponsor's protocol ID
- BT0700-107-BEL
- Status last verified
- Jul 2008
- First submitted
- 17 Jul 2008
- Last updated
- 26 Sep 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Placebo-Controlled, Investigator Blinded, Explorative Trial to Evaluate the Anti-inflammatory Effect of Multiple Topical Applications of R115866 Gel (0.35%) in Two Models of Cutaneous Inflammation in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT00719121
- Acronym / sponsor ID
- BT0700-107-BEL
- Conditions
- Cutaneous Inflammation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Stiefel, a GSK CompanyIndustry (pharma, biotech, devices)
- Study start
- Nov 2006
- Primary completion
- Dec 2006 (actual)
- Study completion
- Mar 2007 (actual)
- First posted
- 21 Jul 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.
The purpose of this exploratory trial is to assess the anti-inflammatory effect(s) of topical R115866 in a model of UVB-induced inflammation and in a model of cutaneous irritation.
Study design
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| A | No intervention | –No Treatment |
| B | Active comparator | Drug: TalarozoleR115866 (0.35% gel) |
| C | Active comparator | Drug: TalarozoleR115866 Vehicle gel |
| D | Active comparator | Drug: Differin™, 0.1% adapalene gelDifferin™, 0.1% adapalene gel |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Body Mass Index should be between 18 and 28 kg/m2
- Subjects are healthy as determined by medical history, physical examination and clinical laboratory tests carried out at screening
- Subjects with a phototype III or IV (according to Fitzpatrick classification)
Key exclusion criteria (9 listed)
- Subjects with history of or active alcohol or substance abuse problems.
- Known hypersensitivity to azoles, adapalene, retinoids or any other ingredient of the gels
- Subjects who have a laboratory value which, in the opinion of the investigator, is clinically-relevant out of the normal range
- Subjects with clinically relevant abnormal ECG-intervals or morphology of the ECG, QTc interval >450 ms
- Use of vitamin A (>1000 µg/day) or the use of concomitant medication, except paracetamol; All other medication must have been stopped at least 14 days before the first administration of gel)
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 |
|---|---|---|
| TalarozoleAlso: Rambazole, R115866Topical Application (20 mg) | Drug | B, C |
| Differin™, 0.1% adapalene gelAlso: adapalene gelTopical Application (20 mg) | Drug | D |
Primary outcome
Primary efficacy endpoint was the mean value of TEWL (Trans-epidermal water loss)
Time frame: Day 1 through Day 9 of treatment
1 secondary outcome
Erythema
Time frame: Day 1 through Day 8 of treatment and Day 15 post-treatment
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 26 Sep 2011.
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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.
Prof. Dr. G. Piérard, MD, PhD principal investigator
Department of Dermatopathology Centre Hospitalier Universitaire du Sart-Tilman
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 Talarozole and Differin™, 0.1% adapalene gel in people with Cutaneous Inflammation, run by Stiefel, a GSK Company at 1 site in Belgium.
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 9 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 26 Sep 2011. 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 Belgium. 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 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?
Primary efficacy endpoint was the mean value of TEWL (Trans-epidermal water loss) (time frame: Day 1 through Day 9 of treatment). 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 26 Sep 2011.