CompletedNCT01474590POWERUpdated Feb 18, 2021Results posted

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

A Phase 3 interventional study of Epiduo/Tactuo and vehicle gel in Acne, sponsored by Galderma R&D. Completed at 26 sites in Canada. Open to participants aged 12 Years to 35 Years. Per ClinicalTrials.gov, last updated 2021-02-18.

Sponsored by Galderma R&D · Phase 3, Interventional, and Treatment

Phase: Phase 3
Study type: Interventional
Enrollment: 266
Allocation: Randomized
Ages: 12 Years to 35 Years
Sex: All

Study summary

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

Conditions studied

Acne

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Acne Vulgaris 730

In context

Acne Vulgaris

730 studies on the registry are indexed under Acne Vulgaris; 85 are open to participants now.

This study's enrollment of 266 is above the median of 68 across 627 interventional studies indexed under Acne Vulgaris.

Browse Acne Vulgaris studies →

Lead sponsor

Galderma R&D is the lead sponsor of 280 studies on the registry; 9 are open to participants now.

Of its 59 completed or terminated interventional studies of FDA-regulated products, 55 (93%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 12 Years to 35 Years
Sexes eligible: All
Accepts healthy volunteers: No

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

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)

Study design

Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Single (Investigator)
Enrollment: 266 participants (actual)

Study arms

Experimental
Epiduo/Tactuo + doxycycline 200mg
Drug: Epiduo/Tactuo · Drug: doxycycline 200mg
Active comparator
Isotretinoin + vehicle gel
Other: vehicle gel · Drug: Isotretinoin

Interventions

DrugEpiduo/Tactuo
topical to the face, once daily in the evening
Othervehicle gel
topical to the face, once daily in the evening
Drugdoxycycline 200mg
oral, 2 capsules once daily in the morning with aglass of water and with food
DrugIsotretinoin
oral, 0.5mg/kg/day for a period of four weeks, adjusted to 1 mg/kg/day for the four following months.

What researchers measure

Primary outcomes

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 : 1. Overall efficacy: reduction of at least 75% of number of nodules at the end of treatment 2. Safe treatment: Absence of any listed safety issues
Time frame: 20 weeks

Results

Posted Aug 28, 2017

Participant flow

Participant flow — Overall Study
Milestone	Epiduo/Tactuo + Doxycycline 200mg	Isotretinoin + Vehicle Gel
Started	133	133
Completed	105	116
Not completed	28	17

Outcome measures

PrimaryThe Primary Outcome is Overall Success, a Composite Endpoint Including Efficacy and Safety Measurements

Overall success is reached when the 2 following criteria are fulfilled : 1. Overall efficacy: reduction of at least 75% of number of nodules at the end of treatment 2. Safe treatment: Absence of any listed safety issues

Time frame:: 20 weeks
Reported as:: Number · count of participants

The Primary Outcome is Overall Success, a Composite Endpoint Including Efficacy and Safety Measurements
count of participants	Epiduo/Tactuo + Doxycycline 200mg	Isotretinoin + Vehicle Gel
The Primary Outcome is Overall Success, a Composite Endpoint Including Efficacy and Safety Measurements	85	73

Adverse events

Collected over 20 weeks. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Epiduo/Tactuo + Doxycycline 200mg	—	0/133 (0%)	25/133 (18.8%)
Isotretinoin + Vehicle Gel	—	1/133 (0.8%)	66/133 (49.6%)

Most frequent serious events

Most frequent serious events
Event	Epiduo/Tactuo + Doxycycline 200mg	Isotretinoin + Vehicle Gel
Stevens-Johnson syndromeSkin and subcutaneous tissue disorders	0/133	1/133

Most frequent other events

Most frequent other events
Event	Epiduo/Tactuo + Doxycycline 200mg	Isotretinoin + Vehicle Gel
lip dryGastrointestinal disorders	9/133	66/133
dry skinSkin and subcutaneous tissue disorders	25/133	43/133
cheilitisGastrointestinal disorders	2/133	32/133
naospharyngitisInfections and infestations	15/133	14/133
skin irritationSkin and subcutaneous tissue disorders	14/133	7/133
nauseaGastrointestinal disorders	14/133	5/133
UPTRI (Upper Tract Respiratory Infection)Infections and infestations	9/133	13/133
headacheNervous system disorders	12/133	11/133
vomitingGastrointestinal disorders	12/133	2/133

Baseline characteristics

Age, Continuous
Age, Continuous(years)	Epiduo/Tactuo + Doxycycline 200mg	Isotretinoin + Vehicle Gel	Total
Mean	19.5 ± 5.0	19.3 ± 4.5	19.4 ± 4.8

Sex: Female, Male
Sex: Female, Male(Participants)	Epiduo/Tactuo + Doxycycline 200mg	Isotretinoin + Vehicle Gel	Total
Female	18	21	39
Male	115	112	227

Region of Enrollment
Region of Enrollment(count of participants)	Epiduo/Tactuo + Doxycycline 200mg	Isotretinoin + Vehicle Gel	Total
Canada	133	133	266

IGA
IGA(count of participants)	Epiduo/Tactuo + Doxycycline 200mg	Isotretinoin + Vehicle Gel	Total
4	118	115	233
5	15	18	33

nodule counts
nodule counts(nodules)	Epiduo/Tactuo + Doxycycline 200mg	Isotretinoin + Vehicle Gel	Total
Mean	8.0 ± 3.6	7.6 ± 2.5	7.8 ± 3.1

Study locations

26 sites

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

References and documents

Publications

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. PubMed 24934963 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Feb 18, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01474590
Lead sponsor: Galderma R&D
Responsible party: Sponsor
First posted: Nov 18, 2011
Start date: Nov 2011
Primary completion: Jul 2013
Completion: Aug 2013
Results posted: Aug 28, 2017
Last update: Feb 18, 2021

Study contacts

Jerry Tan

principal investigator · Windsor Clinical Research Inc.

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.

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