AcnePhase 3POWERNCT01474590

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

A Phase 3 study testing Epiduo/Tactuo, doxycycline 200mg and Isotretinoin in people with Acne, run by Galderma R&D at 25 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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

Who is it for?: Ages 12 to 35 years
Conditions the study is for: Acne
What is being tested?: Epiduo/Tactuo, doxycycline 200mg and Isotretinoin
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 266 participants
Where: 25 sitesCanada
Study dates: Nov 2011to Aug 2013
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 12 to 35 years
All sexes
No healthy volunteers
Child, Adult

Who may be able to join

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

Who cannot join

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

Show all 9Show fewer

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)

Trial locations and contacts

25 sites in 1 country.

City, postcode or hospital

25 sites in 1 country

Canada25 sites

Galderma investigational site
Ajax
Galderma investigational site
Barrie
Galderma investigational site
Calgary
Galderma investigational site
Edmonton
Galderma investigational site
Greater Sudbury
Galderma investigational site
Halifax
Galderma investigational site
Hamilton
Galderma investigational site
Markham
Galderma investigational site
Montreal
Galderma investigational site
Newmarket
Galderma investigational site
Oakville
Galderma investigational site
Oshawa
Galderma investigational site
Peterborough
Galderma investigational site
Québec
Galderma investigational site
Richmond Hill
Galderma investigational site
Saint-Hyacinthe
Galderma investigational site
Saskatoon
Galderma investigational site
St. John's
Galderma investigational site
Surrey
Galderma investigational site
Toronto
Galderma investigational site
Vancouver
Galderma investigational site
Waterloo
Galderma investigational site
Windsor
Galderma investigational site
Winnipeg
Galderma investigational site
Woodbridge

Other trials in Canada

About this study

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

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

Conditions: Acne
Being tested: Epiduo/Tactuo, vehicle gel, doxycycline 200mg, Isotretinoin
Medical subject headings: Acne Vulgaris

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Epiduo/TactuoDrug
topical to the face, once daily in the evening
vehicle gelOther
topical to the face, once daily in the evening
doxycycline 200mgDrug
oral, 2 capsules once daily in the morning with aglass of water and with food
IsotretinoinDrug
oral, 0.5mg/kg/day for a period of four weeks, adjusted to 1 mg/kg/day for the four following months.

Study groups in NCT01474590
Study group	Role	What they receive
Epiduo/Tactuo + doxycycline 200mg	Experimental	Not described Receives: Drug: Epiduo/Tactuo; Drug: doxycycline 200mg
Isotretinoin + vehicle gel	Active comparator	Not described Receives: Other: vehicle gel; Drug: Isotretinoin

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 20 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2011Aug 2013

First posted18 Nov 2011 (estimated)
Study startNov 2011
Primary completionJul 2013
Study completionAug 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for AcneStudies of the same condition, open and under way.
More trials run by Galderma R&DThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Investigator
Enrolment: 266 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01474590
Sponsor's protocol ID: RD.03.SPR.29099
Acronym: POWER
Status last verified: Aug 2017
First submitted: 16 Nov 2011
Last updated: 18 Feb 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 18 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT01474590
Acronym / sponsor ID: POWER / RD.03.SPR.29099
Conditions: Acne
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 266 participants (actual)
Lead sponsor: Galderma R&DIndustry (pharma, biotech, devices)
Study start: Nov 2011
Primary completion: Jul 2013 (actual)
Study completion: Aug 2013 (actual)
First posted: 18 Nov 2011 (estimated)
Results: Posted 28 Aug 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (investigator)
Number of arms: 2

Arm	Type	Receives
Epiduo/Tactuo + doxycycline 200mg	Experimental	Drug: Epiduo/Tactuo, Drug: doxycycline 200mg
Isotretinoin + vehicle gel	Active comparator	Other: vehicle gel, Drug: Isotretinoin

Who may qualify

Ages: 12 to 35 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (9 listed)

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)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Epiduo/Tactuotopical to the face, once daily in the evening	Drug	Epiduo/Tactuo + doxycycline 200mg
vehicle geltopical to the face, once daily in the evening	Other	Isotretinoin + vehicle gel
doxycycline 200mgoral, 2 capsules once daily in the morning with aglass of water and with food	Drug	Epiduo/Tactuo + doxycycline 200mg
Isotretinoinoral, 0.5mg/kg/day for a period of four weeks, adjusted to 1 mg/kg/day for the four following months.	Drug	Isotretinoin + vehicle gel

Primary outcome

The Primary Outcome is Overall Success, a Composite Endpoint Including Efficacy and Safety Measurements
Time frame: 20 weeks
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

Results and safety

Results posted to the registry on 28 Aug 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Epiduo/Tactuo + Doxycycline 200mg	133	105
Isotretinoin + Vehicle Gel	133	116

Primary outcome: The Primary Outcome is Overall Success, a Composite Endpoint Including Efficacy and Safety Measurements

Time frame: 20 weeks. Number. Unit: count of participants

Measure	Epiduo/Tactuo + Doxycycline 200mg n = 133	Isotretinoin + Vehicle Gel n = 133
Value	85	73

Adverse events

Time frame: 20 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Epiduo/Tactuo + Doxycycline 200mg	0 of 133 (0%)	25 of 133 (18.8%)	Not reported
Isotretinoin + Vehicle Gel	1 of 133 (0.8%)	66 of 133 (49.6%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 24934963Tan 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jerry Tan principal investigator

Windsor Clinical Research Inc.

25 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Epiduo/Tactuo, doxycycline 200mg and Isotretinoin in people with Acne, run by Galderma R&D at 25 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 25 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Aug 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The Primary Outcome is Overall Success, a Composite Endpoint Including Efficacy and Safety Measurements (time frame: 20 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01474590, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2021.