Papular-pustular RosaceaPhase 3ISOROSNCT00882531
Isotretinoin in Papular-Pustular Rosacea
A Phase 3 study testing isotretinoin in people with Papular-pustular Rosacea, run by Laboratoires Bailleul-Biorga.
Trial summary
A national, multicentre, prospective, randomised, double-blind, phase III study in 2 parallel groups of isotretinoin versus placebo in patients presenting papular-pustular rosacea resistant to standard therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Papular-pustular Rosacea
- What is being tested?
- isotretinoin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 156 participants
- Where
- No sites listed yet
- Study dates
- Feb 2007to Sep 2009
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult
- Patients presenting papular-pustular rosacea (characterised by at least 8 lesions (papules and/or pustules)
- resistant for at least 3 months in the last two years to standard treatment comprising systemic antibiotics (cyclins) with or without topical therapy
- Full compliance with a two-week wash-out period for all other topical and systemic treatments for rosacea at the time of selection
- For women of childbearing age, use of a minimum of one "effective" contraceptive method for at least one month and willingness to continue using an effective contraceptive method continuously throughout the study duration and for at least one month after the end of treatment.
- Women of childbearing age must provide consent for pregnancy testing before the start of treatment, monthly throughout treatment and 5 weeks after the end of treatment.
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- Negative pregnancy test results from within the last 3 days (for female subjects of childbearing age)
- No laboratory abnormalities in standard tests
- Social Security medical cover
- Provision of written and dated informed consent to take part in the study
Who cannot join
- Patients already receiving isotretinoin for rosacea or within the last 12 months for acne
- Patients presenting perioral dermatitis
- Patients presenting miliary lupoid
- Patients presenting cortisone-induced rosacea
- Pregnant or breast-feeding women
- Patients with repeated and habitual heavy physical activity
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- Patients with known hepatic impairment presenting cytolysis as attested by laboratory results
- Patients presenting hyperaemia
- Patient presenting hypervitaminosis A
- Patients with a history of hypersensitivity to isotretinoin
- Patients with allergy to soy oil
- Patients on tetracycline
- Patients with depression treated at the time of selection
- Patients currently taking part in having taken part in another study in the last 3 months prior to inclusion in the present study
- Patients protected by law (under guardianship or trusteeship)
- Patients unable to comply with the study requirements
About this study
Official title: Evaluation of the Efficacy of Isotretinoin Versus Placebo in Terms of Response Rate Among Patients Presenting Papular-pustular Rosacea Resistant to Standard Therapy
A national, multicentre, prospective, randomised, double-blind, phase III study in 2 parallel groups of isotretinoin versus placebo in patients presenting papular-pustular rosacea resistant to standard therapy. A non-balanced group (2 isotretinoin /1 placebo) design was selected since, given the nature of the study disease, fewer patients will receive the placebo than active isotretinoin.
Treatment duration for each patient : 4 months, with monthly evaluation Follow-up at 2 months and 4 months for patients responsive after 4 months of treatment.
- Conditions
- Papular-pustular Rosacea
- Being tested
- isotretinoin, placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
isotretinoinDrug
0.25 mg/kg, 1 per day, 4 month of treatment
placeboDrug
| Study group | Role | What they receive |
|---|---|---|
| Isotretinoin | Experimental | Not described Receives: Drug: isotretinoin |
| placebo | Placebo comparator | Not described Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine numbers of patients responding to treatment for 4 months with isotretinoin (patients were considered as responders if their number of papular-pustular lesions fell by at least 90% after 4 months of treatment)
Secondary outcomes (6)
Improvement in patients' quality of life using the reduced Skindex-France QoL scale (30 items)
Change in severity of other symptoms of rosacea (burning sensation, erythema, telangiectasia, vasomotor flush, etc)
Patient satisfaction (on a visual analogue scale)
Global treatment efficacy (global assessment)
Relapse rates at 8 months (after start of treatment)
Safety
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2009 (estimated)
- Study startFeb 2007
- Primary completionAug 2009
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Papular-pustular RosaceaStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 156 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laboratoires Bailleul-Biorga
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Quanta Medical
- Investigators
- Olivier CHOSIDOW, Professor, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00882531
- Sponsor's protocol ID
- ISOROS
- Acronym
- ISOROS
- Status last verified
- Nov 2009
- First submitted
- 15 Apr 2009
- Last updated
- 17 Nov 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy of Isotretinoin Versus Placebo in Terms of Response Rate Among Patients Presenting Papular-pustular Rosacea Resistant to Standard Therapy
- ClinicalTrials.gov ID
- NCT00882531
- Acronym / sponsor ID
- ISOROS / ISOROS
- Conditions
- Papular-pustular Rosacea
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 156 participants (actual)
- Lead sponsor
- Laboratoires Bailleul-BiorgaIndustry (pharma, biotech, devices)
- Collaborators
- Quanta Medical
- Study start
- Feb 2007
- Primary completion
- Aug 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 16 Apr 2009 (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.
A national, multicentre, prospective, randomised, double-blind, phase III study in 2 parallel groups of isotretinoin versus placebo in patients presenting papular-pustular rosacea resistant to standard therapy. A non-balanced group (2 isotretinoin /1 placebo) design was selected since, given the nature of the study disease, fewer patients will receive the placebo than active isotretinoin.
Treatment duration for each patient : 4 months, with monthly evaluation Follow-up at 2 months and 4 months for patients responsive after 4 months of treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Isotretinoin | Experimental | Drug: isotretinoin |
| placebo | Placebo comparator | Drug: placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Adult
- Patients presenting papular-pustular rosacea (characterised by at least 8 lesions (papules and/or pustules)
- resistant for at least 3 months in the last two years to standard treatment comprising systemic antibiotics (cyclins) with or without topical therapy
- Full compliance with a two-week wash-out period for all other topical and systemic treatments for rosacea at the time of selection
- For women of childbearing age, use of a minimum of one "effective" contraceptive method for at least one month and willingness to continue using an effective contraceptive method continuously throughout the study duration and for at least one month after the end of treatment.
Key exclusion criteria (16 listed)
- Patients already receiving isotretinoin for rosacea or within the last 12 months for acne
- Patients presenting perioral dermatitis
- Patients presenting miliary lupoid
- Patients presenting cortisone-induced rosacea
- Pregnant or breast-feeding women
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 |
|---|---|---|
| isotretinoin0.25 mg/kg, 1 per day, 4 month of treatment | Drug | Isotretinoin |
| placebo | Drug | placebo |
Primary outcome
To determine numbers of patients responding to treatment for 4 months with isotretinoin (patients were considered as responders if their number of papular-pustular lesions fell by at least 90% after 4 months of treatment)
6 secondary outcomes
Improvement in patients' quality of life using the reduced Skindex-France QoL scale (30 items)
Change in severity of other symptoms of rosacea (burning sensation, erythema, telangiectasia, vasomotor flush, etc)
Patient satisfaction (on a visual analogue scale)
Global treatment efficacy (global assessment)
Relapse rates at 8 months (after start of treatment)
Safety
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 17 Nov 2009.
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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.
Olivier CHOSIDOW, Professor principal investigator
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing isotretinoin in people with Papular-pustular Rosacea, run by Laboratoires Bailleul-Biorga.
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 10 inclusion and 16 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 17 Nov 2009. Status can change between updates, so confirm with the study contact before making plans.
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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
To determine numbers of patients responding to treatment for 4 months with isotretinoin (patients were considered as responders if their number of papular-pustular lesions fell by at least 90% after 4 months 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 17 Nov 2009.