Acne Vulgaris
Conditions
Brief 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
Interventions
DRUGmarketed topical retinoid
once daily application, 4 weeks
DRUGmarketed topical NSAID
once daily application, 4 weeks
DRUGvehicle gel
once daily application, 4 weeks
Sponsors
LEO Pharma
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 35 Years
Healthy volunteers
No
Inclusion criteria
* 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)
Exclusion criteria
* 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. * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage Change in Inflammatory Lesions From Baseline to End of Treatment | Baseline to End of treatment (4 weeks) | Percentage change in inflammatory lesions count from baseline to the end of treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Non-inflammatory Lesions Count | Baseline to End of treatment (4 weeks) | Percentage change in non-inflammatory lesions count from baseline to the end of treatment |
| Total Lesions Count | Baseline to End of treatment (4 weeks) | Percentage change in total lesions count from baseline to the end of treatment |
| Percentage Change in Total Lesions Count | Baseline to Day 8 | Percentage change in total leasions count from baseline to day 8 |
| Investigator Global Assessment (IGA) of Disease Severity | Baseline to End of treatment (4 weeks) | 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. |
Countries
France
Participant flow
Recruitment details
Start date: 21-NOV-2011 (FSFV - first subject first visit) Completion date: 26-APR-2012 (LSLV - last subject last visit)
Participants by arm
| Arm | Count |
|---|---|
| Topical Retinoid - Placebo, Topical Retinoid - NSAID marketed topical retinoid : once daily application, 4 weeks
vehicle gel : once daily application, 4 weeks | 40 |
| Total | 40 |
Baseline characteristics
| Characteristic | Topical Retinoid - Placebo, Topical Retinoid - NSAID |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 40 Participants |
| Age, Continuous | 23.7 years STANDARD_DEVIATION 4.2 |
| Region of Enrollment France | 40 participants |
| Sex: Female, Male Female | 23 Participants |
| Sex: Female, Male Male | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 40 / 40 |
| serious Total, serious adverse events | 0 / 40 |
Outcome results
Primary
Percentage Change in Inflammatory Lesions From Baseline to End of Treatment
Percentage change in inflammatory lesions count from baseline to the end of treatment
Time frame: Baseline to End of treatment (4 weeks)
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Topical Retinoid - Placebo | Percentage Change in Inflammatory Lesions From Baseline to End of Treatment | -20.3 percentage of change | Standard Deviation 45.3 |
| Topical Retinoid-NSAID | Percentage Change in Inflammatory Lesions From Baseline to End of Treatment | -29.4 percentage of change | Standard Deviation 37 |
Secondary
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.
Time frame: Baseline to End of treatment (4 weeks)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Topical Retinoid - Placebo | Investigator Global Assessment (IGA) of Disease Severity | 0 participants |
| Topical Retinoid-NSAID | Investigator Global Assessment (IGA) of Disease Severity | 1 participants |
Secondary
Non-inflammatory Lesions Count
Percentage change in non-inflammatory lesions count from baseline to the end of treatment
Time frame: Baseline to End of treatment (4 weeks)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Topical Retinoid - Placebo | Non-inflammatory Lesions Count | -41.4 percentage of change | Standard Deviation 31.2 |
| Topical Retinoid-NSAID | Non-inflammatory Lesions Count | -43.1 percentage of change | Standard Deviation 37.6 |
Secondary
Percentage Change in Total Lesions Count
Percentage change in total leasions count from baseline to day 8
Time frame: Baseline to Day 8
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Topical Retinoid - Placebo | Percentage Change in Total Lesions Count | -20.4 percentage of change | Standard Deviation 24.1 |
| Topical Retinoid-NSAID | Percentage Change in Total Lesions Count | -21.1 percentage of change | Standard Deviation 28.6 |
Secondary
Percentage Change in Total Lesions Count
Percentage change in total lesions count from baseline to day 15
Time frame: Baseline to Day 15
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Topical Retinoid - Placebo | Percentage Change in Total Lesions Count | -24.9 percentage of change | Standard Deviation 24.3 |
| Topical Retinoid-NSAID | Percentage Change in Total Lesions Count | -22.2 percentage of change | Standard Deviation 29 |
Secondary
Percentage Change in Total Lesions Count
Percentage change in total lesions count from baseline to day 22
Time frame: Baseline to Day 22
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Topical Retinoid - Placebo | Percentage Change in Total Lesions Count | -35.7 percentage of change | Standard Deviation 21.8 |
| Topical Retinoid-NSAID | Percentage Change in Total Lesions Count | -32.5 percentage of change | Standard Deviation 30 |
Secondary
Total Lesions Count
Percentage change in total lesions count from baseline to the end of treatment
Time frame: Baseline to End of treatment (4 weeks)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Topical Retinoid - Placebo | Total Lesions Count | -35.4 percentage of change | Standard Deviation 24 |
| Topical Retinoid-NSAID | Total Lesions Count | -39.9 percentage of change | Standard Deviation 27 |