Severe Acne VulgarisPhase 3ACCESS INCT00688064

Adapalene-BPO Gel Associated With Doxycycline Hyclate 100 mg in the Treatment of Severe Acne Vulgaris

A Phase 3 study testing Adapalene BPO Gel associated with Doxycyline Hyclate in people with Severe Acne Vulgaris, run by Galderma R&D at 34 sites in 3 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

The purpose of this study is to demonstrate the efficacy of Adapalene 0.1% / Benzoyl Peroxide (quoted as BPO) 2.5% Gel associated with Doxycycline Hyclate 100 mg Tablets compared to Adapalene 0.1% /Benzoyl Peroxide 2.5% Vehicle Gel associated with Doxycycline Hyclate 100 mg Tablets, in the treatment of severe acne… Read more about this study

Who is it for?: Ages 12 to 35 years
Conditions the study is for: Severe Acne Vulgaris
What is being tested?: Adapalene BPO Gel associated with Doxycyline Hyclate
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 459 participants
Where: 34 sitesin 3 countries
Study dates: Aug 2008to Feb 2009
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 severe facial acne (global severity score of 4)
Subjects with a minimum of 20 inflammatory lesions (papules and pustules) on the face, excluding the nose
Subjects with a minimum of 30 and a maximum of 120 non-inflammatory lesions (open comedones and closed comedones) on the face, excluding the nose

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.)

Trial locations and contacts

34 sites in 3 countries.

Country

City, postcode or hospital

34 sites in 3 countries

United States28 sites

Galderma Investigational Site
Albuquerque, New Mexico
Galderma Investigational Site
Arlington, Texas
Galderma Investigational Site
Austin, Texas
Galderma Investigational Site
Chicago, Illinois
Galderma Investigational Site
College Station, Texas
Galderma Investigational Site
Denver, Colorado
Galderma Investigational Site
Detroit, Michigan
Galderma Investigational Site
Evansville, Indiana
Galderma Investigational Site
Fort Gratiot, Michigan
Galderma Investigational Site
Fridley, Minnesota
Galderma Investigational Site
Hazleton, Pennsylvania
Galderma Investigational Site
Hershey, Pennsylvania
Galderma Investigational Site
Houston, Texas
Galderma Investigational Site
Longmont, Colorado
Galderma Investigational Site
Louisville, Kentucky
Galderma Investigational Site
Lubbock, Texas
Galderma Investigational Site
Miami, Florida
Galderma Investigational Site
Oceanside, California
Galderma Investigational Site
Omaha, Nebraska
Galderma Investigational Site
Overland Park, Kansas
Galderma Investigational Site
San Antonio, Texas
Galderma Investigational Site
San Diego, California
Galderma Investigational Site
Simpsonville, South Carolina
Galderma Investigational Site
Snellville, Georgia
Galderma Investigational Site
Stony Brook, New York
Galderma Investigational Site
Warren, Ohio
Galderma Investigational Site
Webster, Texas, 77598
Galderma Investigational Site
Winston-Salem, North Carolina

Other trials in United States

Canada4 sites

Galderma Investigational Site
Barrie, Ontario
Galderma Investigational Site
North Bay, Ontario
Galderma Investigational Site
Québec, Quebec
Galderma Investigational Site
Windsor, Ontario

Other trials in Canada

Puerto Rico2 sites

Galderma Investigational Site
Aibonito
Galderma Investigational Site
Carolina

Other trials in Puerto Rico

About this study

Official title: Efficacy and Safety Comparison of Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel Associated With Doxycycline Hyclate 100 mg Tablets Versus Adapalene 0.1% / Benzoyl Peroxide 2.5% Vehicle Gel Associated With Doxycycline Hyclate 100 mg Tablets in the Treatment of Severe Acne Vulgaris.

Read the detailed description

Further to this study, eligible Subjects with at least good Global Assessment of Improvement at Week 12 will be randomized in a maintenance study (SPR.29075)

Conditions: Severe Acne Vulgaris
Being tested: Adapalene BPO Gel associated with Doxycyline Hyclate, Vehicle Gel associated with Doxycycline Hyclate
Keywords: Acne
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 associated with Doxycyline HyclateDrug
Also called Adapalene-BPO gel + Doxycycline
Adapalene BPO Gel: Topical to the face, once daily in the evening Doxycycline Hyclate: Oral, 1 tablet once daily in the morning. Both during 12 weeks.
Vehicle Gel associated with Doxycycline HyclateDrug
Also called Vehicle gel + Doxycycline
Vehicle Gel: Topical to the face, once daily in the evening; Doxycycline Hyclate: Oral, 1 tablet once daily in the morning. Both during 12 weeks.

Study groups in NCT00688064
Study group	Role	What they receive
1	Experimental	Adapalene-BPO + Doxycyline Receives: Drug: Adapalene BPO Gel associated with Doxycyline Hyclate
2	Active comparator	Vehicle + Doxycycline Receives: Drug: Vehicle Gel associated with Doxycycline Hyclate

What is being measured

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

Percent Change From Baseline in Total Lesion Counts at Week 12.
Measured: Week 12

Secondary outcomes (4)

Percent Change From Baseline in Inflammatory Lesion Counts at Week 12.
Measured: Week 12
Percent Change From Baseline in Non-inflammatory Lesion Counts at Week 12
Measured: Week 12
Success Rate on the Investigator's Global Assessment
Percentage of subjects graded "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: Week 12
Percent of Subjects With Adverse Events
Percent of subjects with Adverse Events all along the study (up to 12 weeks follow-up period)
Measured: Up to 12 weeks

Timeline

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

Aug 2008Feb 2009

First posted2 Jun 2008 (estimated)
Study startAug 2008
Primary completionFeb 2009
Study completionFeb 2009

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 Severe 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: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 459 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00688064
Sponsor's protocol ID: RD.03.SPR.29074
Acronym: ACCESS I
Status last verified: Mar 2010
First submitted: 28 May 2008
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

RecruitingPhase 3
Phase 3 Study of Denifanstat in Participants With Moderate to Severe Acne (AURORA)
Acne Vulgaris
Active, not recruitingPhase 3
A Phase 3 Study to Assess Efficacy Safety and Tolerability of Remibrutinib in Adult and Adolescent Patients With Moderate to Severe Hidradenitis Suppurativa (RECHARGE 1)
Hidradenitis Suppurativa
Active, not recruitingPhase 3
A Phase 3 Study to Assess Efficacy Safety and Tolerability of Remibrutinib in Adult and Adolescent Patients With Moderate to Severe Hidradenitis Suppurativa
Hidradenitis Suppurativa
Active, not recruitingPhase 2/3
A Study Evaluating BFB759 in Moderate to Severe Hidradenitis Suppurativa
Hidradenitis Suppurativa (HS)
RecruitingPhase 2
Pharmacokinetics, Safety, and Efficacy of Povorcitinib in Adolescent Participants With Moderate to Severe Hidradenitis Suppurativa
Hidradenitis Suppurativa (HS)

All Severe 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 Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel Associated With Doxycycline Hyclate 100 mg Tablets Versus Adapalene 0.1% / Benzoyl Peroxide 2.5% Vehicle Gel Associated With Doxycycline Hyclate 100 mg Tablets in the Treatment of Severe Acne Vulgaris.
ClinicalTrials.gov ID: NCT00688064
Acronym / sponsor ID: ACCESS I / RD.03.SPR.29074
Conditions: Severe Acne Vulgaris
Keywords: Acne
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 459 participants (actual)
Lead sponsor: Galderma R&DIndustry (pharma, biotech, devices)
Study start: Aug 2008
Primary completion: Feb 2009 (actual)
Study completion: Feb 2009 (actual)
First posted: 2 Jun 2008 (estimated)
Results: Posted 31 Mar 2010

Clinical summary

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

Detailed description

Further to this study, eligible Subjects with at least good Global Assessment of Improvement at Week 12 will be randomized in a maintenance study (SPR.29075)

Study design

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

Arm	Type	Receives
1	Experimental	Drug: Adapalene BPO Gel associated with Doxycyline HyclateAdapalene-BPO + Doxycyline
2	Active comparator	Drug: Vehicle Gel associated with Doxycycline HyclateVehicle + Doxycycline

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 Subjects of any race, aged 12 to 35 years inclusive
Subjects with severe facial acne (global severity score of 4)
Subjects with a minimum of 20 inflammatory lesions (papules and pustules) on the face, excluding the nose
Subjects with a minimum of 30 and a maximum of 120 non-inflammatory lesions (open comedones and closed comedones) on the face, excluding the nose

Key exclusion criteria (2 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.)

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 associated with Doxycyline HyclateAlso: Adapalene-BPO gel + DoxycyclineAdapalene BPO Gel: Topical to the face, once daily in the evening Doxycycline Hyclate: Oral, 1 tablet once daily in the morning. Both during 12 weeks.	Drug	1
Vehicle Gel associated with Doxycycline HyclateAlso: Vehicle gel + DoxycyclineVehicle Gel: Topical to the face, once daily in the evening; Doxycycline Hyclate: Oral, 1 tablet once daily in the morning. Both during 12 weeks.	Drug	2

Primary outcome

Percent Change From Baseline in Total Lesion Counts at Week 12.
Time frame: Week 12

4 secondary outcomes

Percent Change From Baseline in Inflammatory Lesion Counts at Week 12.
Time frame: Week 12
Percent Change From Baseline in Non-inflammatory Lesion Counts at Week 12
Time frame: Week 12
Success Rate on the Investigator's Global Assessment
Time frame: Week 12
Percent of Subjects With Adverse Events
Time frame: Up to 12 weeks

Results and safety

Results posted to the registry on 31 Mar 2010, 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-BPO + Doxycycline	232	211
Vehicle + Doxycycline	227	201

Primary outcome: Percent Change From Baseline in Total Lesion Counts at Week 12.

Time frame: Week 12. Median (Full Range). Unit: % of change

Measure	Adapalene-BPO + Doxycycline n = 232	Vehicle + Doxycycline n = 227
Value	-64 (-100 to 34)	-41 (-92 to 64)

Population analysed: ITT, LOCF

4 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Adapalene-BPO + Doxycycline	0 of 232 (0%)	43 of 232 (18.5%)	Not reported
Vehicle + Doxycycline	0 of 227 (0%)	48 of 227 (21.1%)	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 InfoLink provided by the sponsor.

Related trials for Severe Acne Vulgaris

RecruitingPhase 3
Phase 3 Study of Denifanstat in Participants With Moderate to Severe Acne (AURORA)
Acne Vulgaris
Active, not recruitingPhase 3
A Phase 3 Study to Assess Efficacy Safety and Tolerability of Remibrutinib in Adult and Adolescent Patients With Moderate to Severe Hidradenitis Suppurativa (RECHARGE 1)
Hidradenitis Suppurativa
Active, not recruitingPhase 3
A Phase 3 Study to Assess Efficacy Safety and Tolerability of Remibrutinib in Adult and Adolescent Patients With Moderate to Severe Hidradenitis Suppurativa
Hidradenitis Suppurativa
Active, not recruitingPhase 2/3
A Study Evaluating BFB759 in Moderate to Severe Hidradenitis Suppurativa
Hidradenitis Suppurativa (HS)
RecruitingPhase 2
Pharmacokinetics, Safety, and Efficacy of Povorcitinib in Adolescent Participants With Moderate to Severe Hidradenitis Suppurativa
Hidradenitis Suppurativa (HS)

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.

Linda Stein Gold, MD principal investigator

Henry Ford Medical Center-New Center One, Detroit, MI

34 sites in 3 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 associated with Doxycyline Hyclate in people with Severe Acne Vulgaris, run by Galderma R&D at 34 sites in 3 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 4 inclusion and 2 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 34 sites in United States, Canada, Puerto Rico. 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 31 Mar 2010). 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 Counts at Week 12. (time frame: 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 NCT00688064.

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.