Acne VulgarisPhase 2NCT01461655
Efficacy and the Tolerability of the Sequential Application of Two Marketed Products in Patients With Acne Vulgaris
A Phase 2 study testing marketed topical retinoid and marketed topical NSAID in people with Acne Vulgaris, run by LEO Pharma at 1 site in France.
Trial summary
The aim of this proof of principle study is to evaluate efficacy and safety of the sequential application of two marketed products for the treatment of acne vulgaris, using the Split-Face model Read more about this study
- Who is it for?
- Ages 18 to 35 years
- Conditions the study is for
- Acne Vulgaris
- What is being tested?
- marketed topical retinoid and marketed topical NSAID
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2011to May 2012
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Subjects having understood and signed an informed consent form
- Male or female subjects who are 18 to 35 years (both included) of age presenting acne vulgaris of the face.
- A minimum of 10 inflammatory lesions (papules and pustules) on the entire face, and a minimum of 20 non-inflammatory lesions (open comedones and closed comedones) on the entire face.
- Disease severity grade as mild or moderate according to the investigator's global assessment (grade 2 or grade 3)
Who cannot join
- Females who are pregnant, of child-bearing potential and who wish to become pregnant during the study, or who are breast feeding.
- Subjects with any acne cysts or more than one nodule per hemiface.
- Subjects with acne conglobata, acne fulminans, secondary acne (e.g. chloracne, drug-induced acne), or any acne requiring systemic treatment.
- Subjects with a dark pigmentation of the skin or skin type that may, in any way, confound interpretation of the study results (skin type V or VI on Fitzpatrick scale.
- Subjects with other facial skin disorders that may interfere with study assessments.
- Subjects who will use medicated cosmetics and/or soaps (including soaps containing antibacterial agents such as benzoyl peroxide, keratolytic agents such as salicylic acid, skin fresheners/astringents or aftershave products) on the face for the duration of the study.
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- Subjects with a history of actinic keratosis on the face or skin cancer.
- Use of hormonal oral contraceptives for acne control for less than 6 months prior to the randomisation.
- Subjects using one of the following systemic medication within 4 weeks before the randomisation and during the study, which could have an effect on the trial disease.
- systemic corticosteroids,
- anti-acne drugs,
- oral retinoids
- any immunosuppressive drugs.
- Subjects using systemic NSAIDs (including aspirin) within 1 week before the randomisation and during the study.
- Subjects using paracetamol within 1 week before the randomisation. Paracetamol will be allowed during the study with a maximum dose of 1g twice daily and for a maximum of 3 consecutive days
- Subjects using one of the following topical medication within 2 weeks before the randomisation and during the study, which could have an effect on the trial disease:
- anti-inflammatory drugs (e.g. topical corticosteroids, NSAIDs),
- anti-acne drugs,
- topical retinoids,
- topical antibacterial agents
- any topical immunosuppressive drugs.
- Subjects with known or suspected hypersensitivity to component(s) of the investigational products or other nonsteroidal anti- inflammatory drug NSAIDs (e.g., aspirin, diclofenac, ibuprofen, ketoprofen).
- Subjects with presence of any clinically significant gastrointestinal pathology (e.g. chronic diarrhea, inflammatory bowel diseases), unresolved gastrointestinal symptoms (e.g. diarrhea, vomiting).
- Subjects with known presence of active peptic ulcer.
- Subjects with history (during the last 10 years) or known presence of asthma.
- Subjects with history (during the last 5 years) or known presence of rhinitis or urticaria
Trial locations and contacts
1 site in 1 country.
France1 site
CPCAD - Centre de Pharmacologie Clinique Appliquée à la Dermatologie
Nice, 06202
About this study
Official title: Exploratory Study Evaluating the Efficacy and the Tolerability of the Sequential Application of Two Marketed Products in Patients With Acne Vulgaris, Using a Split-Face Model
The aim of this proof of principle study is to evaluate efficacy and safety of the sequential application of two marketed products for the treatment of acne vulgaris, using the Split-Face model
- Conditions
- Acne Vulgaris
- Being tested
- marketed topical retinoid, marketed topical NSAID, vehicle 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.
marketed topical retinoidDrug
once daily application, 4 weeks
marketed topical NSAIDDrug
once daily application, 4 weeks
vehicle gelDrug
once daily application, 4 weeks
marketed topical retinoidDrug
once daily application, 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Topical retinoid - Placebo | Placebo comparator | Not described Receives: Drug: vehicle gel; Drug: marketed topical retinoid |
| Topical retinoid-NSAID | Active comparator | Not described Receives: Drug: marketed topical retinoid; Drug: marketed topical NSAID |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage Change in Inflammatory Lesions From Baseline to End of Treatment
Percentage change in inflammatory lesions count from baseline to the end of treatment
Measured: Baseline to End of treatment (4 weeks)
Secondary outcomes (6)
Non-inflammatory Lesions Count
Percentage change in non-inflammatory lesions count from baseline to the end of treatment
Measured: Baseline to End of treatment (4 weeks)
Total Lesions Count
Percentage change in total lesions count from baseline to the end of treatment
Measured: Baseline to End of treatment (4 weeks)
Percentage Change in Total Lesions Count
Percentage change in total leasions count from baseline to day 8
Measured: Baseline to Day 8
Percentage Change in Total Lesions Count
Percentage change in total lesions count from baseline to day 15
Measured: Baseline to Day 15
Percentage Change in Total Lesions Count
Percentage change in total lesions count from baseline to day 22
Measured: Baseline to Day 22
Investigator Global Assessment (IGA) of Disease Severity
The investigator made an assessment of the disease severity (Plaque thickening, Scaling and Erythema) using a 6-point scale (Clear, Almost clear, Mild, Moderate, Severe, and Very severe).
The outcome was the proportion of "success" (improvement of two grades of the IGA) from baseline to the end of treatment. "Success" is defined as improvement of two grades from the baseline assessment.
Measured: Baseline to End of treatment (4 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2011 (estimated)
- Study startNov 2011
- Primary completionApr 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Acne VulgarisStudies 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
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- LEO Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Catherine Mrs Queille-Roussel, MD, Principal investigator, Centre de Pharmacologie Clinique Applique a la Dermatologie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01461655
- Sponsor's protocol ID
- LP0045-01
- Other IDs
- 2011-000244-24
- Status last verified
- Dec 2016
- First submitted
- 25 Oct 2011
- Last updated
- 10 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Study Evaluating the Efficacy and the Tolerability of the Sequential Application of Two Marketed Products in Patients With Acne Vulgaris, Using a Split-Face Model
- ClinicalTrials.gov ID
- NCT01461655
- Acronym / sponsor ID
- LP0045-01
- Conditions
- Acne Vulgaris
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- LEO PharmaIndustry (pharma, biotech, devices)
- Study start
- Nov 2011
- Primary completion
- Apr 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 28 Oct 2011 (estimated)
- Results
- Posted 4 Dec 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this proof of principle study is to evaluate efficacy and safety of the sequential application of two marketed products for the treatment of acne vulgaris, using the Split-Face model
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Topical retinoid - Placebo | Placebo comparator | Drug: vehicle gel, Drug: marketed topical retinoid |
| Topical retinoid-NSAID | Active comparator | Drug: marketed topical retinoid, Drug: marketed topical NSAID |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Subjects having understood and signed an informed consent form
- Male or female subjects who are 18 to 35 years (both included) of age presenting acne vulgaris of the face.
- A minimum of 10 inflammatory lesions (papules and pustules) on the entire face, and a minimum of 20 non-inflammatory lesions (open comedones and closed comedones) on the entire face.
- Disease severity grade as mild or moderate according to the investigator's global assessment (grade 2 or grade 3)
Key exclusion criteria (26 listed)
- Females who are pregnant, of child-bearing potential and who wish to become pregnant during the study, or who are breast feeding.
- Subjects with any acne cysts or more than one nodule per hemiface.
- Subjects with acne conglobata, acne fulminans, secondary acne (e.g. chloracne, drug-induced acne), or any acne requiring systemic treatment.
- Subjects with a dark pigmentation of the skin or skin type that may, in any way, confound interpretation of the study results (skin type V or VI on Fitzpatrick scale.
- Subjects with other facial skin disorders that may interfere with study assessments.
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 |
|---|---|---|
| marketed topical retinoidonce daily application, 4 weeks | Drug | Topical retinoid-NSAID |
| marketed topical NSAIDonce daily application, 4 weeks | Drug | Topical retinoid-NSAID |
| vehicle gelonce daily application, 4 weeks | Drug | Topical retinoid - Placebo |
| marketed topical retinoidonce daily application, 4 weeks | Drug | Topical retinoid - Placebo |
Primary outcome
Percentage Change in Inflammatory Lesions From Baseline to End of Treatment
Time frame: Baseline to End of treatment (4 weeks)
Percentage change in inflammatory lesions count from baseline to the end of treatment
6 secondary outcomes
Non-inflammatory Lesions Count
Time frame: Baseline to End of treatment (4 weeks)
Total Lesions Count
Time frame: Baseline to End of treatment (4 weeks)
Percentage Change in Total Lesions Count
Time frame: Baseline to Day 8
Percentage Change in Total Lesions Count
Time frame: Baseline to Day 15
Percentage Change in Total Lesions Count
Time frame: Baseline to Day 22
Investigator Global Assessment (IGA) of Disease Severity
Time frame: Baseline to End of treatment (4 weeks)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Catherine Mrs Queille-Roussel, MD principal investigator
Centre de Pharmacologie Clinique Applique a la Dermatologie
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing marketed topical retinoid and marketed topical NSAID in people with Acne Vulgaris, run by LEO Pharma at 1 site in France.
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 4 inclusion and 26 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 10 Mar 2025. 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 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 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?
Yes. Results are posted in the registry (first posted 4 Dec 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage Change in Inflammatory Lesions From Baseline to End of Treatment (time frame: Baseline to End of treatment (4 weeks)). 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 10 Mar 2025.