Acne VulgarisPhase 3TEAMNCT01014689

Comparison of Epiduo Associated With Lymecycline Versus Epiduo Vehicle Associated With Lymecycline in Acne Vulgaris

A Phase 3 study testing Adapalene/ BPO gel with Lymecycline capsules in people with Acne Vulgaris, run by Galderma R&D at 28 sites in 9 countries.

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

Randomized, controlled, multi-center, double-blind, parallel-group comparison study in Subjects with moderate to severe acne vulgaris on the face. The purpose of this study is to demonstrate the efficacy of Adapalene 0.1% / Benzoyl Peroxide (BPO) 2.5% Gel associated with Lymecycline 300mg Capsules compared to… Read more about this study

Who is it for?: Ages 12 to 35 years
Conditions the study is for: Acne Vulgaris
What is being tested?: Adapalene/ BPO gel with Lymecycline capsules
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 378 participants
Where: 28 sitesin 9 countries
Study dates: Aug 2009to May 2010
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 Subjects of any race, aged 12 to 35 years inclusive,
Subjects with moderate to severe facial acne vulgaris (Investigator's Global Assessment score of 3 or 4),

Who cannot join

Subjects with more than 3 nodules or cysts on the face
Subjects with acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne, etc.),
Subjects with a wash-out period for topical treatment on the face less than: Corticosteroids, antibiotics, antibacterials, antiseptics, retinoids, other anti-inflammatory drugs or other acne treatments (2 weeks), Zinc containing drugs (1 week), Phototherapy devices for acne and cosmetic procedures (1 week)
Subjects with a wash-out period for systemic treatment less than:Acne therapy containing zinc (4 weeks), Corticosteroids, antibiotics (4 weeks), Other acne treatments (6 months), Ciproterone acetate / Chlormadinone acetate (6 months), Spironolactone / Drospirenone (3 months)
Subjects with impaired hepatic (ALT/AST > 3xULN and bilirubin > 1.5xULN) or renal (creatinine clearance greater than 60 ml/min) functions based on a blood sample,
Subjects with known intolerance to lactose,

Trial locations and contacts

28 sites in 9 countries.

Country

City, postcode or hospital

28 sites in 9 countries

France6 sites

Galderma Investigator site
Bordeaux
Galderma Investigator site
Cannes
Galderma Investigator site
Martigues
Galderma Investigator site
Nantes
Galderma Investigator site
Pantin
Galderma Investigator site
Pierre-Bénite

Other trials in France

Australia4 sites

Galderma Investigator site
Canberra
Galderma Investigator site
Kogarah
Galderma Investigator site
Melbourne
Galderma Investigator site
Sydney

Other trials in Australia

Mexico4 sites

Galderma Investigator site
Mexico City
Galderma Investigator site
Monterrey
Galderma Investigator site
Tlalnepantla
Galderma Investigator site
Zapopan

Other trials in Mexico

Belgium3 sites

Galderma Investigator site
Brussels
Galderma Investigator site
Ghent
Galderma Investigator site
Leuven

Other trials in Belgium

Germany3 sites

Galderma Investigator site
Cuxhaven
Galderma Investigator site
Darmstadt
Galderma Investigator site
Frankfurt

Other trials in Germany

Sweden3 sites

Galderma Investigator site
Eskilstuna
Galderma Investigator site
Färsta
Galderma Investigator site
Hägersten

Other trials in Sweden

Brazil2 sites

Galderma Investigator site
Belo Horizonte
Galderma Investigator site
São Paulo

Other trials in Brazil

Italy2 sites

Galderma Investigator site
Catania
Galderma Investigator site
Ferrara

Other trials in Italy

Poland1 site

Galderma Investigator site
Lodz

Other trials in Poland

About this study

Official title: Efficacy and Safety Comparison of Epiduo Gel Associated With Lymecycline 300 mg Capsules Versus Epiduo Vehicle Gel Associated With Lymecycline 300 mg Capsules in the Treatment of Moderate to Severe Acne Vulgaris

Randomized, controlled, multi-center, double-blind, parallel-group comparison study in Subjects with moderate to severe acne vulgaris on the face.

The purpose of this study is to demonstrate the efficacy of Adapalene 0.1% / Benzoyl Peroxide (BPO) 2.5% Gel associated with Lymecycline 300mg Capsules compared to Adapalene 0.1% /Benzoyl Peroxide 2.5% Vehicle Gel associated with Lymecycline 300mg Capsules, in the treatment of moderate to severe acne vulgaris.

The safety of the two treatment regimens will also be evaluated.

Conditions: Acne Vulgaris
Being tested: Adapalene/ BPO gel with Lymecycline capsules, Adapalene/ BPO vehicle gel with Lymecycline capsules
Keywords: acne vulgaris
Medical subject headings: Acne Vulgaris

What participants receive

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

Adapalene/ BPO gel with Lymecycline capsulesDrug
Also called Adapalene/BPO with Lymecycline
Gel: Topical to the face, once daily in the evening Capsule: 1 capsule once daily in the morning
Adapalene/ BPO vehicle gel with Lymecycline capsulesDrug
Also called Adapalene/BPO vehicle with Lymecycline
Gel: Topical to the face, once daily in the evening Capsule: 1 capsule once daily in the morning

Study groups in NCT01014689
Study group	Role	What they receive
Adapalene 0.1% / BPO 2.5% gel	Active comparator	Not described Receives: Drug: Adapalene/ BPO gel with Lymecycline capsules
Adapalene 0.1% / BPO 2.5% Vehicle Gel	Placebo comparator	Not described Receives: Drug: Adapalene/ BPO vehicle gel with Lymecycline capsules

What is being measured

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

Percent Change From Baseline in Total Lesion Count
Percent change from Baseline in Total Lesion count (sum of Non-Inflammatory and Inflammatory lesions) at Week 12.
Measured: Baseline and Week 12

Secondary outcomes (1)

Success Rate on the Investigator's Global Assessment (IGA) at Week 12
Percentage of Subjects "Clear" or "Almost Clear" on 6-point IGA scale(0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe and 5=very severe) at Week 12.
Measured: Baseline and Week 12

Timeline

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

Aug 2009May 2010

First posted17 Nov 2009 (estimated)
Study startAug 2009
Primary completionApr 2010
Study completionMay 2010

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.
Other trials for Acne VulgarisStudies 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: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 378 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01014689
Sponsor's protocol ID: RD.03.SPR.29080
Acronym: TEAM
Status last verified: Apr 2012
First submitted: 16 Nov 2009
Last updated: 18 Feb 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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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All Acne Vulgaris trials

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 Epiduo Gel Associated With Lymecycline 300 mg Capsules Versus Epiduo Vehicle Gel Associated With Lymecycline 300 mg Capsules in the Treatment of Moderate to Severe Acne Vulgaris
ClinicalTrials.gov ID: NCT01014689
Acronym / sponsor ID: TEAM / RD.03.SPR.29080
Conditions: Acne Vulgaris
Keywords: acne vulgaris
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 378 participants (actual)
Lead sponsor: Galderma R&DIndustry (pharma, biotech, devices)
Study start: Aug 2009
Primary completion: Apr 2010 (actual)
Study completion: May 2010 (actual)
First posted: 17 Nov 2009 (estimated)
Results: Posted 5 Apr 2012

Clinical summary

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

Randomized, controlled, multi-center, double-blind, parallel-group comparison study in Subjects with moderate to severe acne vulgaris on the face.

The safety of the two treatment regimens will also be evaluated.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Adapalene 0.1% / BPO 2.5% gel	Active comparator	Drug: Adapalene/ BPO gel with Lymecycline capsules
Adapalene 0.1% / BPO 2.5% Vehicle Gel	Placebo comparator	Drug: Adapalene/ BPO vehicle gel with Lymecycline capsules

Who may qualify

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

Key inclusion criteria (2 listed)

Male or female Subjects of any race, aged 12 to 35 years inclusive,
Subjects with moderate to severe facial acne vulgaris (Investigator's Global Assessment score of 3 or 4),

Key exclusion criteria (6 listed)

Subjects with more than 3 nodules or cysts on the face
Subjects with acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne, etc.),
Subjects with a wash-out period for topical treatment on the face less than: Corticosteroids, antibiotics, antibacterials, antiseptics, retinoids, other anti-inflammatory drugs or other acne treatments (2 weeks), Zinc containing drugs (1 week), Phototherapy devices for acne and cosmetic procedures (1 week)
Subjects with a wash-out period for systemic treatment less than:Acne therapy containing zinc (4 weeks), Corticosteroids, antibiotics (4 weeks), Other acne treatments (6 months), Ciproterone acetate / Chlormadinone acetate (6 months), Spironolactone / Drospirenone (3 months)
Subjects with impaired hepatic (ALT/AST > 3xULN and bilirubin > 1.5xULN) or renal (creatinine clearance greater than 60 ml/min) functions based on a blood sample,

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
Adapalene/ BPO gel with Lymecycline capsulesAlso: Adapalene/BPO with LymecyclineGel: Topical to the face, once daily in the evening Capsule: 1 capsule once daily in the morning	Drug	Adapalene 0.1% / BPO 2.5% gel
Adapalene/ BPO vehicle gel with Lymecycline capsulesAlso: Adapalene/BPO vehicle with LymecyclineGel: Topical to the face, once daily in the evening Capsule: 1 capsule once daily in the morning	Drug	Adapalene 0.1% / BPO 2.5% Vehicle Gel

Primary outcome

Percent Change From Baseline in Total Lesion Count
Time frame: Baseline and Week 12
Percent change from Baseline in Total Lesion count (sum of Non-Inflammatory and Inflammatory lesions) at Week 12.

1 secondary outcome

Success Rate on the Investigator's Global Assessment (IGA) at Week 12
Time frame: Baseline and Week 12

Results and safety

Results posted to the registry on 5 Apr 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Adapalene 0.1% / BPO 2.5% Gel + Lymecycline	191	178
Adapalene 0.1% / BPO 2.5% Vehicle Gel + Lymecycline	187	174

Primary outcome: Percent Change From Baseline in Total Lesion Count

Time frame: Baseline and Week 12. Median (Full Range). Unit: percent of change

Measure	Adapalene 0.1% / BPO 2.5% Gel + Lymecycline n = 191	Adapalene 0.1% / BPO 2.5% Vehicle Gel + Lymecycline n = 187
Value	-74.1 (-100 to 7.7)	-56.8 (-97.8 to 73.2)

Population analysed: Intention to treat - Last observation carried forward

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 12 weeks.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Adapalene 0.1% / BPO 2.5% Gel + Lymecycline	0 of 191 (0%)	25 of 191 (13.1%)	Not reported
Adapalene 0.1% / BPO 2.5% Vehicle Gel + Lymecycline	0 of 187 (0%)	26 of 187 (13.9%)	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.

Related trials for Acne Vulgaris

Not yet recruitingPhase 3
Evaluation of the Efficacy and Safety of Fractional CO₂ Laser With and Without Intradermal Botulinum Toxin A in the Treatment of Inflammatory Facial Acne Vulgaris.
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RecruitingPhase 4
Safety, Tolerability, and Clinical Effectiveness of Adapalene/Clindamycin Phosphate Gel (Klenzit®-C) in Vietnamese Patients With Mild to Moderate Acne Vulgaris
Acne
RecruitingPhase 3
Phase 3 Study of Denifanstat in Participants With Moderate to Severe Acne (AURORA)
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RecruitingPhase 4
Comparing Nadifloxacin Plus Tretinoin Versus Clindamycin Plus Tretinoin Creams for Mild-to-Moderate Acne
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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.

Florence Paliargues study director

Galderma R&D

28 sites in 9 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Adapalene/ BPO gel with Lymecycline capsules in people with Acne Vulgaris, run by Galderma R&D at 28 sites in 9 countries.

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 2 inclusion and 6 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 28 sites in France, Australia, Mexico, Belgium, Germany and 4 more countries. 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. Some participants in this study may receive a placebo. 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 5 Apr 2012). 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?

Percent Change From Baseline in Total Lesion Count (time frame: Baseline and Week 12). 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 NCT01014689.

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.