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

Acne Clinical Trial

— POWER  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01474590
• Other study ID #: RD.03.SPR.29099
• Status: Completed
• Phase: Phase 3
• Start date: November 2011
• Est. completion date: August 2013

Study information

• Verified date: August 2017
• Source: Galderma R&D
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 266
• Est. completion date: August 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 35 Years

Eligibility

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)

Related Conditions & MeSH terms

• Acne
• Acne Vulgaris

Intervention

Drug:
• Epiduo/Tactuo
topical to the face, once daily in the evening

Other:
• vehicle gel
topical to the face, once daily in the evening

Drug:
• 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.

Locations

Country	Name	City	State
Canada	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

Sponsors (1)

Lead Sponsor	Collaborator
Galderma R&D

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Primary Outcome is Overall Success, a Composite Endpoint Including Efficacy and Safety Measurements	Overall success is reached when the 2 following criteria are fulfilled : Overall efficacy: reduction of at least 75% of number of nodules at the end of treatment; Safe treatment: Absence of any listed safety issues	20 weeks