AcnePhase 2NCT00725439
An Open Label Trial to Assess the Safety and Efficacy of Oral R115866 in the Treatment Facial Acne
A Phase 2 study testing Talarozole in people with Acne, run by Stiefel, a GSK Company at 3 sites in 2 countries.
Trial summary
This study is looking at a new oral drug to treat acne. All patients in the study will get active drug, there is no placebo arm. Read more about this study
- Who is it for?
- Ages 16 to 50 years, men only
- Conditions the study is for
- Acne
- What is being tested?
- Talarozole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Sep 2004to Dec 2007
- Phase
- Phase 2
- 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 16 to 50 years
- Men only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Male subject
- Presence of moderate to severe facial acne vulgaris: having a minimum of 15 papules and/or pustules and at least 2 nodulocystic lesions
- In good general health and free of any disease state or physical condition which, in the investigator's opinion, might have impaired evaluation of acne or exposed the subject to an unacceptable risk by trial participation
Who cannot join
- Subjects with types of acne other than acne vulgaris
- Significant coexisting hepatic, renal, or bone marrow disease, hyperlipidemia, chronic pancreatitis, osteoporosis, or a history indicating adrenal cortex dysfunction or any other serious disease (including cancer and subjects known to be HIV positive)
- History of any malignancy in the past 5 years, except for adequately treated basal cell carcinoma of the skin
- History of heart failure, myocardial infarction within the past six months, cardiac arrhythmia, or under treatment for heart disorders
- Clinically significant abnormal ECG-intervals or morphology of the ECG; QT or QTc >470 ms in females or >450 ms in males
- Use of vitamin A (>1000 microgram/day), phenytoin, carbamazepine, warfarin, rifampicin, tetracyclines, ketoconazole, itraconazole, astemizole, terfenadine, cisapride, anti-psychotics, anti-depressants, lithium, antimalarials, alpha-blocking drugs, angiotensin-converting enzyme inhibitors, cyclosporin A, glucocorticosteroids and non-steroid anti-inflammatory drugs, non-potassium-sparing diuretics
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- Use of oral retinoids 6 months prior to Visit 1
- Use of other oral/topical therapy for acne unless stopped at Visit 1
- Use of ultraviolet light (including artificial UVA and UVB as well as excessive natural sun exposure) unless stopped at Visit 1
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Belgium2 sites
Department of Dermatology, UZ Brussel
Brussels, B-1090
Private Practice in Dermatology
Vilvoorde, B-1800
Netherlands1 site
Albert Schweitzer Hospital, Dermatology
Zwijndrecht, NL-3331 LZ
About this study
Official title: An Open Label Pilot Trial to Assess the Safety and Efficacy of Oral R115866 in the Treatment of Moderate to Severe Facial Acne
This study is looking at a new oral drug to treat acne. All patients in the study will get active drug, there is no placebo arm.
- Conditions
- Acne
- Being tested
- Talarozole
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TalarozoleDrug
Also called Rambazole, R115866
Oral Dose 1.0 mg once daily
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Talarozole Receives: Drug: Talarozole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Facial Lesion Count
Measured: Post 12 weeks treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2008 (estimated)
- Study startSep 2004
- Primary completionJul 2005
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AcneStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stiefel, a GSK Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Prof. Dr. D. Roseeuw, MD, Principal investigator, Department Dermatology, University Hospital Brussel (UZ Brussel)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00725439
- Sponsor's protocol ID
- BT0700BEL001
- Status last verified
- Sep 2011
- 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
- An Open Label Pilot Trial to Assess the Safety and Efficacy of Oral R115866 in the Treatment of Moderate to Severe Facial Acne
- ClinicalTrials.gov ID
- NCT00725439
- Acronym / sponsor ID
- BT0700BEL001
- Conditions
- Acne
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Stiefel, a GSK CompanyIndustry (pharma, biotech, devices)
- Study start
- Sep 2004
- Primary completion
- Jul 2005 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 30 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.
This study is looking at a new oral drug to treat acne. All patients in the study will get active drug, there is no placebo arm.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: TalarozoleTalarozole |
Who may qualify
- Ages
- 16 to 50 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Male subject
- Presence of moderate to severe facial acne vulgaris: having a minimum of 15 papules and/or pustules and at least 2 nodulocystic lesions
- In good general health and free of any disease state or physical condition which, in the investigator's opinion, might have impaired evaluation of acne or exposed the subject to an unacceptable risk by trial participation
Key exclusion criteria (9 listed)
- Subjects with types of acne other than acne vulgaris
- Significant coexisting hepatic, renal, or bone marrow disease, hyperlipidemia, chronic pancreatitis, osteoporosis, or a history indicating adrenal cortex dysfunction or any other serious disease (including cancer and subjects known to be HIV positive)
- History of any malignancy in the past 5 years, except for adequately treated basal cell carcinoma of the skin
- History of heart failure, myocardial infarction within the past six months, cardiac arrhythmia, or under treatment for heart disorders
- Clinically significant abnormal ECG-intervals or morphology of the ECG; QT or QTc >470 ms in females or >450 ms in males
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, R115866Oral Dose 1.0 mg once daily | Drug | A |
Primary outcome
Facial Lesion Count
Time frame: Post 12 weeks 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. D. Roseeuw, MD principal investigator
Department Dermatology, University Hospital Brussel (UZ Brussel)
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Talarozole in people with Acne, run by Stiefel, a GSK Company at 3 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 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 3 sites in Belgium, Netherlands. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Facial Lesion Count (time frame: Post 12 weeks 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.