Severe Acne Vulgaris
Conditions
Keywords
Acne
Brief summary
The purpose of this study is to demonstrate the efficacy of Adapalene 0.1% / Benzoyl Peroxide (quoted as BPO) 2.5% Gel associated with Doxycycline Hyclate 100 mg Tablets compared to Adapalene 0.1% /Benzoyl Peroxide 2.5% Vehicle Gel associated with Doxycycline Hyclate 100 mg Tablets, in the treatment of severe acne vulgaris. The safety of the two treatment regimens will also be evaluated.
Detailed description
Further to this study, eligible Subjects with at least good Global Assessment of Improvement at Week 12 will be randomized in a maintenance study (SPR.29075)
Interventions
DRUGAdapalene BPO Gel associated with Doxycyline Hyclate
Adapalene BPO Gel: Topical to the face, once daily in the evening Doxycycline Hyclate: Oral, 1 tablet once daily in the morning. Both during 12 weeks.
DRUGVehicle Gel associated with Doxycycline Hyclate
Vehicle Gel: Topical to the face, once daily in the evening; Doxycycline Hyclate: Oral, 1 tablet once daily in the morning. Both during 12 weeks.
Sponsors
Galderma R&D
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
12 Years to 35 Years
Healthy volunteers
No
Inclusion criteria
* Male or female Subjects of any race, aged 12 to 35 years inclusive * Subjects with severe facial acne (global severity score of 4) * Subjects with a minimum of 20 inflammatory lesions (papules and pustules) on the face, excluding the nose * Subjects with a minimum of 30 and a maximum of 120 non-inflammatory lesions (open comedones and closed comedones) on the face, excluding the nose
Exclusion criteria
* Subjects with more than 3 nodules or cysts on the face, * Subjects with acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne, etc.)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent Change From Baseline in Total Lesion Counts at Week 12. | Week 12 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change From Baseline in Inflammatory Lesion Counts at Week 12. | Week 12 | — |
| Percent Change From Baseline in Non-inflammatory Lesion Counts at Week 12 | Week 12 | — |
| Success Rate on the Investigator's Global Assessment | Week 12 | Percentage of subjects graded 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 |
| Percent of Subjects With Adverse Events | Up to 12 weeks | Percent of subjects with Adverse Events all along the study (up to 12 weeks follow-up period) |
Countries
Canada, Puerto Rico, United States
Participant flow
Recruitment details
Recruitment period: 18 AUG 2008 to 14 NOV 2008 in thirty-five centers (30 in the USA and 5 in Canada) public or private practices. Twenty-five USA centers and four Candadian centers used a central IRB, and the others used a local IRB.
Participants by arm
| Arm | Count |
|---|---|
| Adapalene-BPO + Doxycycline Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel associated with Doxycyline Hyclate 100 mg tablet. | 232 |
| Vehicle + Doxycycline Vehicle Gel associated with Doxycycline Hyclate 100 mg tablet | 227 |
| Total | 459 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 2 | 4 |
| Overall Study | Any other reasons | 1 | 3 |
| Overall Study | Lack of Efficacy | 0 | 1 |
| Overall Study | Lost to Follow-up | 10 | 10 |
| Overall Study | Pregnancy | 1 | 0 |
| Overall Study | Protocol Violation | 0 | 1 |
| Overall Study | Withdrawal by Subject | 7 | 7 |
Baseline characteristics
| Characteristic | Adapalene-BPO + Doxycycline | Vehicle + Doxycycline | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 152 Participants | 156 Participants | 308 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 80 Participants | 71 Participants | 151 Participants |
| Age, Continuous | 18.6 years STANDARD_DEVIATION 5.84 | 18.1 years STANDARD_DEVIATION 4.92 | 18.4 years STANDARD_DEVIATION 5.41 |
| Region of Enrollment Canada | 44 participants | 45 participants | 89 participants |
| Region of Enrollment Puerto Rico | 18 participants | 18 participants | 36 participants |
| Region of Enrollment United States | 170 participants | 164 participants | 334 participants |
| Sex: Female, Male Female | 108 Participants | 97 Participants | 205 Participants |
| Sex: Female, Male Male | 124 Participants | 130 Participants | 254 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 43 / 232 | 48 / 227 |
| serious Total, serious adverse events | 0 / 232 | 0 / 227 |
Outcome results
Primary
Percent Change From Baseline in Total Lesion Counts at Week 12.
Time frame: Week 12
Population: ITT, LOCF
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Adapalene-BPO + Doxycycline | Percent Change From Baseline in Total Lesion Counts at Week 12. | -64 % of change |
| Vehicle + Doxycycline | Percent Change From Baseline in Total Lesion Counts at Week 12. | -41 % of change |
Secondary
Percent Change From Baseline in Inflammatory Lesion Counts at Week 12.
Time frame: Week 12
Population: ITT, LOCF
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Adapalene-BPO + Doxycycline | Percent Change From Baseline in Inflammatory Lesion Counts at Week 12. | -72 % of change |
| Vehicle + Doxycycline | Percent Change From Baseline in Inflammatory Lesion Counts at Week 12. | -48 % of change |
Secondary
Percent Change From Baseline in Non-inflammatory Lesion Counts at Week 12
Time frame: Week 12
Population: ITT, LOCF
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Adapalene-BPO + Doxycycline | Percent Change From Baseline in Non-inflammatory Lesion Counts at Week 12 | -61 % of change |
| Vehicle + Doxycycline | Percent Change From Baseline in Non-inflammatory Lesion Counts at Week 12 | -40 % of change |
Secondary
Percent of Subjects With Adverse Events
Percent of subjects with Adverse Events all along the study (up to 12 weeks follow-up period)
Time frame: Up to 12 weeks
Population: ITT
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Adapalene-BPO + Doxycycline | Percent of Subjects With Adverse Events | 26.3 % of subjects |
| Vehicle + Doxycycline | Percent of Subjects With Adverse Events | 26.9 % of subjects |
Secondary
Success Rate on the Investigator's Global Assessment
Percentage of subjects graded 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: Week 12
Population: ITT, LOCF
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Adapalene-BPO + Doxycycline | Success Rate on the Investigator's Global Assessment | 31.5 % of subjects |
| Vehicle + Doxycycline | Success Rate on the Investigator's Global Assessment | 8.4 % of subjects |