AcnePhase 1NCT01688531
A Pilot Study to Investigate Filiation Between Primary and Secondary Lesions in Acne Patients
A Phase 1 study testing CD0271 0.1%/CD1579 2.5% gel in people with Acne, run by Galderma R&D at 3 sites in 2 countries.
Trial summary
Exploratory, international, multi-centre, randomized, investigator blinded study in acne Read more about this study
- Who is it for?
- Ages 18 to 35 years
- Conditions the study is for
- Acne
- What is being tested?
- CD0271 0.1%/CD1579 2.5% gel
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 38 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Aug 2012to Sep 2013
- 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 35 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male or female subjects aged 18 to 35 years inclusive
- Subjects with active, moderate acne
Who cannot join
- The subject has a secondary acne form (chloracne, drug-induced acne, etc.) (Screening)
- The subject has a severity of acne that is not amenable to treatment with CD0271-CD1579 (Screening)
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Canada2 sites
Galderma Investigational site
Montreal, Quebec
Galderma Investigational site
Windsor, Ontario
About this study
Exploratory, international, multi-centre, randomized, investigator blinded study in acne
- Conditions
- Acne
- Being tested
- CD0271 0.1%/CD1579 2.5% gel, CD0271 0.1%/CD1579 2.5% gel vehicle
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CD0271 0.1%/CD1579 2.5% gelDrug
one application (pea-sized amount according to the labelling) on a half-face, 5 to 7 days for 6 months
CD0271 0.1%/CD1579 2.5% gel vehicleDrug
one application (pea-sized amount according to the labelling) on a half-face, 5 to 7 days for 6 months
| Study group | Role | What they receive |
|---|---|---|
| CD0271 0.1%/CD1579 2.5% gel | Experimental | Split-face design, one application a day for 6 months Receives: Drug: CD0271 0.1%/CD1579 2.5% gel vehicle |
| CD0271 0.1%/CD1579 2.5% gel vehicle | Placebo comparator | Split-face design, one application a day for 6 months Receives: Drug: CD0271 0.1%/CD1579 2.5% gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Description and documentation of acne lesions
Measured: over 6 months
Secondary outcomes (1)
Treatment effect on acne lesions
Measured: over 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2012 (estimated)
- Study startAug 2012
- Primary completionSep 2013
- Study completionSep 2013
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.
- More trials run by Galderma R&DThe 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Galderma R&D
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01688531
- Sponsor's protocol ID
- RD.03.SPR.40183E
- Status last verified
- Mar 2016
- First submitted
- 17 Sep 2012
- Last updated
- 18 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Investigate Filiation Between Primary and Secondary Lesions in Acne Patients
- ClinicalTrials.gov ID
- NCT01688531
- Acronym / sponsor ID
- RD.03.SPR.40183E
- Conditions
- Acne
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Galderma R&DIndustry (pharma, biotech, devices)
- Study start
- Aug 2012
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 20 Sep 2012 (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.
Exploratory, international, multi-centre, randomized, investigator blinded study in acne
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CD0271 0.1%/CD1579 2.5% gel | Experimental | Drug: CD0271 0.1%/CD1579 2.5% gel vehicleSplit-face design, one application a day for 6 months |
| CD0271 0.1%/CD1579 2.5% gel vehicle | Placebo comparator | Drug: CD0271 0.1%/CD1579 2.5% gelSplit-face design, one application a day for 6 months |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Male or female subjects aged 18 to 35 years inclusive
- Subjects with active, moderate acne
Key exclusion criteria (2 listed)
- The subject has a secondary acne form (chloracne, drug-induced acne, etc.) (Screening)
- The subject has a severity of acne that is not amenable to treatment with CD0271-CD1579 (Screening)
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 |
|---|---|---|
| CD0271 0.1%/CD1579 2.5% gelone application (pea-sized amount according to the labelling) on a half-face, 5 to 7 days for 6 months | Drug | CD0271 0.1%/CD1579 2.5% gel vehicle |
| CD0271 0.1%/CD1579 2.5% gel vehicleone application (pea-sized amount according to the labelling) on a half-face, 5 to 7 days for 6 months | Drug | CD0271 0.1%/CD1579 2.5% gel |
Primary outcome
Description and documentation of acne lesions
Time frame: over 6 months
1 secondary outcome
Treatment effect on acne lesions
Time frame: over 6 months
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 18 Sep 2019.
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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.
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CD0271 0.1%/CD1579 2.5% gel in people with Acne, run by Galderma R&D 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 2 inclusion and 2 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 18 Sep 2019. 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 Canada, France. 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?
Description and documentation of acne lesions (time frame: over 6 months). 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 18 Sep 2019.