Acne Vulgaris
Conditions
Keywords
acne vulgaris
Brief summary
Randomized, controlled, multi-center, double-blind, parallel-group comparison study in Subjects with moderate to severe acne vulgaris on the face. The purpose of this study is to demonstrate the efficacy of Adapalene 0.1% / Benzoyl Peroxide (BPO) 2.5% Gel associated with Lymecycline 300mg Capsules compared to Adapalene 0.1% /Benzoyl Peroxide 2.5% Vehicle Gel associated with Lymecycline 300mg Capsules, in the treatment of moderate to severe acne vulgaris. The safety of the two treatment regimens will also be evaluated.
Interventions
DRUGAdapalene/ BPO gel with Lymecycline capsules
Gel: Topical to the face, once daily in the evening Capsule: 1 capsule once daily in the morning
DRUGAdapalene/ BPO vehicle gel with Lymecycline capsules
Gel: Topical to the face, once daily in the evening Capsule: 1 capsule once daily in the morning
Sponsors
Galderma R&D
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
12 Years to 35 Years
Healthy volunteers
No
Inclusion criteria
1. Male or female Subjects of any race, aged 12 to 35 years inclusive, 2. Subjects with moderate to severe facial acne vulgaris (Investigator's Global Assessment score of 3 or 4),
Exclusion criteria
1. Subjects with more than 3 nodules or cysts on the face 2. Subjects with acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne, etc.), 3. Subjects with a wash-out period for topical treatment on the face less than: Corticosteroids, antibiotics, antibacterials, antiseptics, retinoids, other anti-inflammatory drugs or other acne treatments (2 weeks), Zinc containing drugs (1 week), Phototherapy devices for acne and cosmetic procedures (1 week) 4. Subjects with a wash-out period for systemic treatment less than:Acne therapy containing zinc (4 weeks), Corticosteroids, antibiotics (4 weeks), Other acne treatments (6 months), Ciproterone acetate / Chlormadinone acetate (6 months), Spironolactone / Drospirenone (3 months) 5. Subjects with impaired hepatic (ALT/AST \> 3xULN and bilirubin \> 1.5xULN) or renal (creatinine clearance greater than 60 ml/min) functions based on a blood sample, 6. Subjects with known intolerance to lactose,
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change From Baseline in Total Lesion Count | Baseline and Week 12 | Percent change from Baseline in Total Lesion count (sum of Non-Inflammatory and Inflammatory lesions) at Week 12. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Success Rate on the Investigator's Global Assessment (IGA) at Week 12 | Baseline and Week 12 | Percentage of Subjects Clear or Almost Clear on 6-point IGA scale(0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe and 5=very severe) at Week 12. |
Countries
Australia, Belgium, Brazil, France, Germany, Italy, Mexico, Poland, Sweden
Participant flow
Recruitment details
Recruitment period 14/08/2009 to 21/01/2010 Type of location: hospital, private hospital and private practice.
Participants by arm
| Arm | Count |
|---|---|
| Adapalene 0.1% / BPO 2.5% Gel + Lymecycline Gel applied once daily in the evening during 12 weeks Lymecycline 300mg taken once daily in the morning during 12 weeks | 191 |
| Adapalene 0.1% / BPO 2.5% Vehicle Gel + Lymecycline Gel applied once daily in the evening during 12 weeks Lymecycline 300mg taken once daily in the morning during 12 weeks | 187 |
| Total | 378 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 3 | 0 |
| Overall Study | Lack of Efficacy | 0 | 1 |
| Overall Study | Lost to Follow-up | 3 | 7 |
| Overall Study | Pregnancy | 1 | 0 |
| Overall Study | Protocol Violation | 1 | 1 |
| Overall Study | Withdrawal by Subject | 5 | 4 |
Baseline characteristics
| Characteristic | Adapalene 0.1% / BPO 2.5% Gel + Lymecycline | Adapalene 0.1% / BPO 2.5% Vehicle Gel + Lymecycline | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 113 Participants | 102 Participants | 215 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 78 Participants | 85 Participants | 163 Participants |
| Age, Continuous | 18.6 years STANDARD_DEVIATION 4.7 | 19.1 years STANDARD_DEVIATION 4.6 | 18.9 years STANDARD_DEVIATION 4.6 |
| Region of Enrollment Australia | 15 participants | 18 participants | 33 participants |
| Region of Enrollment Belgium | 14 participants | 13 participants | 27 participants |
| Region of Enrollment Brazil | 18 participants | 17 participants | 35 participants |
| Region of Enrollment France | 26 participants | 25 participants | 51 participants |
| Region of Enrollment Germany | 18 participants | 17 participants | 35 participants |
| Region of Enrollment Italy | 14 participants | 14 participants | 28 participants |
| Region of Enrollment Mexico | 52 participants | 52 participants | 104 participants |
| Region of Enrollment Poland | 16 participants | 16 participants | 32 participants |
| Region of Enrollment Sweden | 18 participants | 15 participants | 33 participants |
| Sex: Female, Male Female | 91 Participants | 78 Participants | 169 Participants |
| Sex: Female, Male Male | 100 Participants | 109 Participants | 209 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 25 / 191 | 26 / 187 |
| serious Total, serious adverse events | 0 / 191 | 0 / 187 |
Outcome results
Primary
Percent Change From Baseline in Total Lesion Count
Percent change from Baseline in Total Lesion count (sum of Non-Inflammatory and Inflammatory lesions) at Week 12.
Time frame: Baseline and Week 12
Population: Intention to treat - Last observation carried forward
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Adapalene 0.1% / BPO 2.5% Gel + Lymecycline | Percent Change From Baseline in Total Lesion Count | -74.1 percent of change |
| Adapalene 0.1% / BPO 2.5% Vehicle Gel + Lymecycline | Percent Change From Baseline in Total Lesion Count | -56.8 percent of change |
Secondary
Success Rate on the Investigator's Global Assessment (IGA) at Week 12
Percentage of Subjects Clear or Almost Clear on 6-point IGA scale(0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe and 5=very severe) at Week 12.
Time frame: Baseline and Week 12
Population: Intention To treat - Last Observation Carried Forward
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Adapalene 0.1% / BPO 2.5% Gel + Lymecycline | Success Rate on the Investigator's Global Assessment (IGA) at Week 12 | 47.6 percent of subjects |
| Adapalene 0.1% / BPO 2.5% Vehicle Gel + Lymecycline | Success Rate on the Investigator's Global Assessment (IGA) at Week 12 | 33.7 percent of subjects |