DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



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

Information source: Galderma
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Acne

Intervention: Epiduo/Tactuo + doxycycline 200mg (Drug); Isotretinoin + vehicle gel (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Galderma

Official(s) and/or principal investigator(s):
Jerry Tan, Principal Investigator, Affiliation: -

Summary

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

Clinical Details

Official title: Efficacy and Safety Comparison of Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel Associated With 200 mg Doxycycline Capsules Versus Vehicle Gel Associated With Isotretinoin Capsules in the Treatment of Severe Acne

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Primary outcome: The primary outcome is overall success, a composite endpoint including efficacy and safety measurements

Eligibility

Minimum age: 12 Years. Maximum age: 35 Years. Gender(s): Both.

Criteria:

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)

Locations and Contacts

Galderma investigational site, Ajax, Canada

Galderma investigational site, Barrie, Canada

Galderma investigational site, Calgary, Canada

Galderma investigational site, Edmonton, 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, Quebec city, Canada

Galderma investigational site, Richmond Hill, Canada

Galderma investigational site, Saint-Hyacinthe, Canada

Galderma investigational site, Saint-John's, Canada

Galderma investigational site, Saskatoon, Canada

Galderma investigational site, St John's, Canada

Galderma investigational site, Sudbury, 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

Additional Information

Starting date: November 2011
Last updated: November 22, 2013

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017