Efficacy & Safety Comparison of Epiduo With Doxycycline Versus Vehicle With Isotretinoin in the Treatment of Severe Acne (POWER)

Galderma

Status and phase: Completed; Phase 3

Conditions: Acne

Treatments: Drug: Isotretinoin; Other: vehicle gel; Drug: Epiduo/Tactuo; Drug: doxycycline 200mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT01474590

RD.03.SPR.29099

Details and patient eligibility

About

Non-inferiority, randomized, controlled, multi-center, investigator-blind, parallel-group comparison study in subjects with severe acne vulgaris on the face.

Enrollment: 266 patients

Sex: All

Ages: 12 to 35 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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266 participants in 2 patient groups

Epiduo/Tactuo + doxycycline 200mg

Experimental group

Treatment:

Drug: doxycycline 200mg

Drug: Epiduo/Tactuo

Isotretinoin + vehicle gel

Active Comparator group

Treatment:

Drug: Isotretinoin

Other: vehicle gel