Acne
Conditions
Brief summary
Non-inferiority, randomized, controlled, multi-center, investigator-blind, parallel-group comparison study in subjects with severe acne vulgaris on the face.
Interventions
DRUGEpiduo/Tactuo
topical to the face, once daily in the evening
OTHERvehicle gel
topical to the face, once daily in the evening
DRUGdoxycycline 200mg
oral, 2 capsules once daily in the morning with aglass of water and with food
DRUGIsotretinoin
oral, 0.5mg/kg/day for a period of four weeks, adjusted to 1 mg/kg/day for the four following months.
Sponsors
Galderma R&D
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
12 Years to 35 Years
Healthy volunteers
No
Inclusion criteria
1. Male or female subject of any race, aged 12 to 35 years inclusive 2. Subject weighing between 50 and 110 kg 3. Subject with severe acne (IGA at least 4), which in the opinion of the investigator is appropriate for treatment with oral isotretinoin (severe nodular acne, severe inflammatory acne, recalcitrant acne; all unresponsive to conventional first line therapies) 4. Subject with at least 5 nodules on the face
Exclusion criteria
1. Subject with clinically abnormal results to blood testings performed at screening 2. Subject with acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne, etc.), pyoderma faciale, sinus tracks 3. Female subject who is pregnant, nursing or planning a pregnancy during the study 4. Subject with known history of hepatic and/or renal insufficiency, to be confirmed by blood testings 5. Subject with known metabolic or structural bone disease (for 12-17 years old population) 6. Subject with bowel disease and/or with hypervitaminosis A 7. Subject who presents with treated or untreated depression or has a history of depression including a family history of major depression 8. Subject with a wash-out period from baseline for topical treatment on the face less than : Corticosteroids, antibiotics, antibacterials, antiseptics, retinoids, other anti-inflammatory drugs or other acne treatments (2 weeks); Cosmetic procedures (1 week); Photodynamic therapy and laser therapy for acne (3 months) 9. Subject with a wash-out period from baseline for systemic treatment less than: Corticosteroids, antibiotics (4 weeks),Progesterone for contraception (3 months); Spironolactone(3 months); Other acne treatments (6 months);Cyproterone acetate(6 months)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Primary Outcome is Overall Success, a Composite Endpoint Including Efficacy and Safety Measurements | 20 weeks | Overall success is reached when the 2 following criteria are fulfilled : 1. Overall efficacy: reduction of at least 75% of number of nodules at the end of treatment 2. Safe treatment: Absence of any listed safety issues |
Countries
Canada
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Epiduo/Tactuo + Doxycycline 200mg Epiduo/Tactuo + doxycycline 200mg: Epiduo gel: topical to the face, once daily in the evening Doxycycline: oral, 2 capsules a day. The capsules should be taken with a glass of water and with food either as a single dose or in two divided doses during the day. | 133 |
| Isotretinoin + Vehicle Gel Isotretinoin + vehicle gel: Vehicle gel: topical to the face, once daily in the evening Isotretinoin: oral, 0.5mg/kg/day for a period of four weeks, adjusted to 1 mg/kg/day for the four following months. | 133 |
| Total | 266 |
Baseline characteristics
| Characteristic | Epiduo/Tactuo + Doxycycline 200mg | Isotretinoin + Vehicle Gel | Total |
|---|---|---|---|
| Age, Continuous | 19.5 years STANDARD_DEVIATION 5 | 19.3 years STANDARD_DEVIATION 4.5 | 19.4 years STANDARD_DEVIATION 4.8 |
| IGA 4 | 118 count of participants | 115 count of participants | 233 count of participants |
| IGA 5 | 15 count of participants | 18 count of participants | 33 count of participants |
| nodule counts | 8.0 nodules STANDARD_DEVIATION 3.6 | 7.6 nodules STANDARD_DEVIATION 2.5 | 7.8 nodules STANDARD_DEVIATION 3.1 |
| Region of Enrollment Canada | 133 count of participants | 133 count of participants | 266 count of participants |
| Sex: Female, Male Female | 18 Participants | 21 Participants | 39 Participants |
| Sex: Female, Male Male | 115 Participants | 112 Participants | 227 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 25 / 133 | 66 / 133 |
| serious Total, serious adverse events | 0 / 133 | 1 / 133 |
Outcome results
Primary
The Primary Outcome is Overall Success, a Composite Endpoint Including Efficacy and Safety Measurements
Overall success is reached when the 2 following criteria are fulfilled : 1. Overall efficacy: reduction of at least 75% of number of nodules at the end of treatment 2. Safe treatment: Absence of any listed safety issues
Time frame: 20 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Epiduo/Tactuo + Doxycycline 200mg | The Primary Outcome is Overall Success, a Composite Endpoint Including Efficacy and Safety Measurements | 85 count of participants |
| Isotretinoin + Vehicle Gel | The Primary Outcome is Overall Success, a Composite Endpoint Including Efficacy and Safety Measurements | 73 count of participants |