AcnePhase 2NCT01106807
Exploratory Study to Evaluate the Efficacy and Safety of CD07223 Gel in Subjects With Acne
A Phase 2 study testing CD07223 and Epiduo (adapalene and benzoyl peroxide) 0.1%/2.5% gel in people with Acne, run by Galderma R&D at 9 sites in United States.
Trial summary
The purpose of the study is to evaluate the efficacy of CD07223 1.5% Gel and 0.5% gel in reducing inflammatory, non-inflammatory, and total acne lesion counts after 6 weeks of twice daily applications. The study will also evaluate the safety of the study products using tolerance and adverse event data. Read more about this study
- Who is it for?
- Ages 18 to 35 years
- Conditions the study is for
- Acne
- What is being tested?
- CD07223 and Epiduo (adapalene and benzoyl peroxide) 0.1%/2.5% gel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- 9 sitesUnited States
- Study dates
- Apr 2010to Sep 2010
- 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 18 to 35 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- subject has a clinical diagnosis of acne vulgaris with facial involvement
- the subject has at least 15 inflammatory lesions and 25 non-inflammatory lesions (excluding the nose) but no more than 2 nodules on the face
Who cannot join
- subject has a severe acne form or secondary acne form
- the number of inflammatory or non-inflammatory lesions on one half-face is greater than twice the number on the other half-face
- the subject has a known allergy or sensitivity to any of the components of the study products
- subject is not willing to respect wash-out periods for topical and/or systemic treatments
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Derm Research, Inc
Austin, Texas, 78759
J & S Studies
Bryan, Texas, 77845
Cetero
Fargo, North Dakota, 58104
Burke Pharmaceuticals
Hot Springs, Arkansas
Dermatology Specialist PSC
Louisville, Kentucky, 40202
Education and Research Foundation, Inc
Lynchburg, Virginia, 24501
TKL Research
Rochelle Park, New Jersey, 07662
Grekin Skin Institute
Warren, Michigan, 48088
Piedmont Medical Research
Winston-Salem, North Carolina, 27103
About this study
Official title: Exploratory Study to Evaluate the Efficacy and Safety of CD07223 1.5% Gel and 0.5% Gel in Subjects With Acne
The purpose of the study is to evaluate the efficacy of CD07223 1.5% Gel and 0.5% gel in reducing inflammatory, non-inflammatory, and total acne lesion counts after 6 weeks of twice daily applications. The study will also evaluate the safety of the study products using tolerance and adverse event data.
- Conditions
- Acne
- Being tested
- Epiduo vehicle gel, CD07223, Epiduo (adapalene and benzoyl peroxide) 0.1%/2.5% gel
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epiduo vehicle gelDrug
500 microliters of Epiduo vehicle gel on one half-face twice daily for six weeks
CD07223Drug
500 microliters of CD07223 1.5% gel on one half-face twice daily for six weeks
CD07223Drug
500 microliters of CD07223 0.5% gel on one half-face twice daily for six weeks
Epiduo (adapalene and benzoyl peroxide) 0.1%/2.5% gelDrug
500 microliters Epiduo Gel on one of the half-face for the morning dose
| Study group | Role | What they receive |
|---|---|---|
| CD07223 1.5% gel | Experimental | 500 microliters of CD07223 1.5% gel on one half-face twice daily for six weeks and Epiduo vehicle gel on the other half-face Receives: Drug: Epiduo vehicle gel; Drug: CD07223 |
| CD07223 0.5% gel | Experimental | 500 microliters of CD07223 0.5% gel on one half-face twice daily for six weeks and Epiduo vehicle gel on the other half-face Receives: Drug: Epiduo vehicle gel; Drug: CD07223 |
| Epiduo (adapalene and benzoyl peroxide) 0.1%/2.5% gel | Active comparator | 500 microliters of Epiduo (adapalene and benzoyl peroxide) 0.1%/2.5% gel on one half-face and 500 microliters of the Epiduo vehicle gel on the other half-face in the morning and in the afternoon, 500 microliters of Epiduo vehicle gel on both half-faces Receives: Drug: Epiduo vehicle gel; Drug: Epiduo (adapalene and benzoyl peroxide) 0.1%/2.5% gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total acne lesion count
change in total number of acne lesion count from baseline to end of treatment
Measured: 6 weeks
Percent change of acne lesion count
Percent change of acne lesion count from baseline to end of treatment
Measured: 6 weeks
Secondary outcomes (4)
Lesion counts- Inflammatory
change in lesion count from baseline at each evaluation visit; efficacy preference at the end of treatment by investigator and subject
Measured: 6 weeks
Lesion count- non-inflammatory
change in lesion count from baseline at each evaluation visit; efficacy preference at the end of treatment by investigator and subject
Measured: 6 weeks
Lesion counts- Inflammatory
Percent change of acne lesion count from baseline at each evaluation visit
Measured: 6 weeks
Lesion count- non-inflammatory
Percent change of acne lesion count from baseline at each evaluation visit
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2010 (estimated)
- Study startApr 2010
- Primary completionSep 2010
- Study completionSep 2010
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Galderma R&D
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael Graeber, MD, Study director, Galderma R&D
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01106807
- Sponsor's protocol ID
- RD.06.SPR.18173
- Status last verified
- Apr 2012
- First submitted
- 19 Apr 2010
- Last updated
- 18 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Study to Evaluate the Efficacy and Safety of CD07223 1.5% Gel and 0.5% Gel in Subjects With Acne
- ClinicalTrials.gov ID
- NCT01106807
- Acronym / sponsor ID
- RD.06.SPR.18173
- Conditions
- Acne
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Galderma R&DIndustry (pharma, biotech, devices)
- Study start
- Apr 2010
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 20 Apr 2010 (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 the study is to evaluate the efficacy of CD07223 1.5% Gel and 0.5% gel in reducing inflammatory, non-inflammatory, and total acne lesion counts after 6 weeks of twice daily applications. The study will also evaluate the safety of the study products using tolerance and adverse event data.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CD07223 1.5% gel | Experimental | Drug: Epiduo vehicle gel, Drug: CD07223500 microliters of CD07223 1.5% gel on one half-face twice daily for six weeks and Epiduo vehicle gel on the other half-face |
| CD07223 0.5% gel | Experimental | Drug: Epiduo vehicle gel, Drug: CD07223500 microliters of CD07223 0.5% gel on one half-face twice daily for six weeks and Epiduo vehicle gel on the other half-face |
| Epiduo (adapalene and benzoyl peroxide) 0.1%/2.5% gel | Active comparator | Drug: Epiduo vehicle gel, Drug: Epiduo (adapalene and benzoyl peroxide) 0.1%/2.5% gel500 microliters of Epiduo (adapalene and benzoyl peroxide) 0.1%/2.5% gel on one half-face and 500 microliters of the Epiduo vehicle gel on the other half-face in the morning and in the afternoon, 500 microliters of Epiduo vehicle gel on both half-faces |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- subject has a clinical diagnosis of acne vulgaris with facial involvement
- the subject has at least 15 inflammatory lesions and 25 non-inflammatory lesions (excluding the nose) but no more than 2 nodules on the face
Key exclusion criteria (4 listed)
- subject has a severe acne form or secondary acne form
- the number of inflammatory or non-inflammatory lesions on one half-face is greater than twice the number on the other half-face
- the subject has a known allergy or sensitivity to any of the components of the study products
- subject is not willing to respect wash-out periods for topical and/or systemic treatments
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 |
|---|---|---|
| Epiduo vehicle gel500 microliters of Epiduo vehicle gel on one half-face twice daily for six weeks | Drug | CD07223 0.5% gel, CD07223 1.5% gel, Epiduo (adapalene and benzoyl peroxide) 0.1%/2.5% gel |
| CD07223500 microliters of CD07223 1.5% gel on one half-face twice daily for six weeks | Drug | CD07223 1.5% gel |
| CD07223500 microliters of CD07223 0.5% gel on one half-face twice daily for six weeks | Drug | CD07223 0.5% gel |
| Epiduo (adapalene and benzoyl peroxide) 0.1%/2.5% gel500 microliters Epiduo Gel on one of the half-face for the morning dose | Drug | Epiduo (adapalene and benzoyl peroxide) 0.1%/2.5% gel |
Primary outcome
Total acne lesion count
Time frame: 6 weeks
change in total number of acne lesion count from baseline to end of treatment
Percent change of acne lesion count
Time frame: 6 weeks
Percent change of acne lesion count from baseline to end of treatment
4 secondary outcomes
Lesion counts- Inflammatory
Time frame: 6 weeks
Lesion count- non-inflammatory
Time frame: 6 weeks
Lesion counts- Inflammatory
Time frame: 6 weeks
Lesion count- non-inflammatory
Time frame: 6 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 18 Feb 2021.
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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.
Michael Graeber, MD study director
Galderma R&D
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CD07223 and Epiduo (adapalene and benzoyl peroxide) 0.1%/2.5% gel in people with Acne, run by Galderma R&D at 9 sites in United States.
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 4 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 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. 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?
Total acne lesion count (time frame: 6 weeks). The study lists 2 primary outcomes in all. 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 Feb 2021.