Efficacy & Safety Comparison of Epiduo With Doxycycline Versus Vehicle With Isotretinoin in the Treatment of Severe Acne
NCT ID: NCT01474590
Last Updated: 2021-02-18
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
266 participants
INTERVENTIONAL
2011-11-30
2013-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Epiduo/Tactuo + doxycycline 200mg
Epiduo/Tactuo
topical to the face, once daily in the evening
doxycycline 200mg
oral, 2 capsules once daily in the morning with aglass of water and with food
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.
Interventions
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Epiduo/Tactuo
topical to the face, once daily in the evening
vehicle gel
topical to the face, once daily in the evening
doxycycline 200mg
oral, 2 capsules once daily in the morning with aglass of water and with food
Isotretinoin
oral, 0.5mg/kg/day for a period of four weeks, adjusted to 1 mg/kg/day for the four following months.
Eligibility Criteria
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Inclusion Criteria
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
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)
12 Years
35 Years
ALL
No
Sponsors
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Galderma R&D
INDUSTRY
Responsible Party
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Principal Investigators
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Jerry Tan
Role: PRINCIPAL_INVESTIGATOR
Windsor Clinical Research Inc.
Locations
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Galderma investigational site
Ajax, , Canada
Galderma investigational site
Barrie, , Canada
Galderma investigational site
Calgary, , Canada
Galderma investigational site
Edmonton, , Canada
Galderma investigational site
Greater Sudbury, , Canada
Galderma investigational site
Halifax, , Canada
Galderma investigational site
Hamilton, , Canada
Galderma investigational site
Markham, , Canada
Galderma investigational site
Montreal, , Canada
Galderma investigational site
Newmarket, , Canada
Galderma investigational site
Oakville, , Canada
Galderma investigational site
Oshawa, , Canada
Galderma investigational site
Peterborough, , Canada
Galderma investigational site
Québec, , Canada
Galderma investigational site
Richmond Hill, , Canada
Galderma investigational site
Saint-Hyacinthe, , Canada
Galderma investigational site
Saskatoon, , Canada
Galderma investigational site
St. John's, , Canada
Galderma investigational site
Surrey, , Canada
Galderma investigational site
Toronto, , Canada
Galderma investigational site
Vancouver, , Canada
Galderma investigational site
Waterloo, , Canada
Galderma investigational site
Windsor, , Canada
Galderma investigational site
Winnipeg, , Canada
Galderma investigational site
Woodbridge, , Canada
Countries
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References
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Tan J, Humphrey S, Vender R, Barankin B, Gooderham M, Kerrouche N, Audibert F, Lynde C; POWER study group. A treatment for severe nodular acne: a randomized investigator-blinded, controlled, noninferiority trial comparing fixed-dose adapalene/benzoyl peroxide plus doxycycline vs. oral isotretinoin. Br J Dermatol. 2014 Dec;171(6):1508-16. doi: 10.1111/bjd.13191. Epub 2014 Oct 28.
Other Identifiers
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RD.03.SPR.29099
Identifier Type: -
Identifier Source: org_study_id
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