Phase 3
N=266
Efficacy & Safety Comparison of Epiduo With Doxycycline Versus Vehicle With Isotretinoin in the Treatment of Severe Acne
Acne
Bottom Line
View on ClinicalTrials.gov: NCT01474590 ↗Enrolled (actual)
266
Serious AEs
0.4%
Results posted
Aug 2017
Primary outcome: Primary: The Primary Outcome is Overall Success, a Composite Endpoint Including Efficacy and Safety Measurements — 85; 73 count of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Epiduo/Tactuo (Drug); vehicle gel (Other); doxycycline 200mg (Drug); Isotretinoin (Drug)
- Age
- Pediatric, Adult · 12+ yrs
- Sex
- All
- Sponsor
- Galderma R&D
- Primary completion
- Jul 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Primary Outcome is Overall Success, a Composite Endpoint Including Efficacy and Safety Measurements |
85; 73 | — |
Summary
Non-inferiority, randomized, controlled, multi-center, investigator-blind, parallel-group comparison study in subjects with severe acne vulgaris on the face.
Eligibility Criteria
Inclusion Criteria
- Male or female subject of any race, aged 12 to 35 years inclusive
- Subject weighing between 50 and 110 kg
- 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)
- Subject with at least 5 nodules on the face
Exclusion Criteria
- Subject with clinically abnormal results to blood testings performed at screening
- Subject with acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne, etc.), pyoderma faciale, sinus tracks
- Female subject who is pregnant, nursing or planning a pregnancy during the study
- Subject with known history of hepatic and/or renal insufficiency, to be confirmed by blood testings
- Subject with known metabolic or structural bone disease (for 12-17 years old population)
- Subject with bowel disease and/or with hypervitaminosis A
- Subject who presents with treated or untreated depression or has a history of depression including a family history of major depression
- 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)
- 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)
Data sourced from ClinicalTrials.gov (NCT01474590). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.