Phase 3
Completed N=266
Efficacy & Safety Comparison of Epiduo With Doxycycline Versus Vehicle With Isotretinoin in the Treatment of Severe Acne
Source: ClinicalTrials.gov NCT01474590 ↗Enrolled (actual)
266
Serious AEs
0.4%
Results posted
Aug 2017
Primary outcomePrimary: The Primary Outcome is Overall Success, a Composite Endpoint Including Efficacy and Safety Measurements — 85; 73 count of participants
◆ Published Evidence
Established
51citations · ~4 / year
A treatment for severe nodular acne: a randomized investigator-blinded, controlled, noninferiority trial comparing fixed-dose adapalene/benzoyl peroxide plus doxycycline vs. oral isotretinoin.
Summary
Non-inferiority, randomized, controlled, multi-center, investigator-blind, parallel-group comparison study in subjects with severe acne vulgaris on the face.
Linked Publications
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A treatment for severe nodular acne: a randomized investigator-blinded, controlled, noninferiority trial comparing fixed-dose adapalene/benzoyl peroxide plus doxycycline vs. oral isotretinoin.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Primary Outcome is Overall Success, a Composite Endpoint Including Efficacy and Safety Measurements |
85; 73 | — |
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) and the linked publication. 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. Informational only — not medical advice.