Acne VulgarisPhase 4NCT01209949

Assessment of Subjects' Efficacy and Experiences Using Adapalene BPO Gel in the Treatment of Acne Vulgaris

A Phase 4 study testing Adapalene 0.1% and Benzoyl Peroxide 2.5% gel in people with Acne Vulgaris, run by Galderma R&D at 1 site in United States.

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 assess subjects' experiences using Adapalene BPO gel to treat mild to moderate acne vulgaris using efficacy measurements, quality of life instruments, and video diaries. Read more about this study

Who is it for?: Ages 16 to 25 years
Conditions the study is for: Acne Vulgaris
What is being tested?: Adapalene 0.1% and Benzoyl Peroxide 2.5% gel
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 30 participants
Where: 1 siteUnited States
Study dates: Oct 2010to Jan 2011
Phase: Phase 4
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 16 to 25 years
All sexes
No healthy volunteers
Child, Adult

Who may be able to join

Male or female subjects, aged 16 to 25 years inclusive;
Subjects with mild or moderate facial acne (Investigator's Global Assessment (IGA) = 2 or 3;
A minimum of 10 inflammatory lesions (papules and pustules) on the face (excluding the nose);
Subjects who agree to be photographed at each visit;
Subjects who agree to be video recorded by study designated staff members. They should be able to clearly and comfortably communicate their responses to questions and express their thoughts related to their disease and treatment throughout the study

Who cannot join

Subjects with nodules, cysts, acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne, etc.) or severe acne requiring systemic treatment;
Subjects with a wash-out period for topical acne treatment on the face less than 30 days
Subjects with a wash-out period for systemic acne treatment less than 30 days with the exception of isotretinoin which requires a washout of 4 months;
Subjects who are currently being treated with antibiotics;
Subjects who foresee intensive ultraviolet (UV) exposure during the study (mountain sports, UV radiation, sunbathing, tanning beds, etc.);
Subjects who refuse photographic and videography procedures and/or refuse to sign a full release for their use in promotional materials

Trial locations and contacts

1 site in 1 country.

United States1 site

Thomas J. Stephens and Associates
Carrollton, Texas, 75006

Other trials in United States

About this study

Conditions: Acne Vulgaris
Being tested: Adapalene 0.1% and Benzoyl Peroxide 2.5% gel
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 0.1% and Benzoyl Peroxide 2.5% gelDrug
Also called Epiduo® Gel
Apply adapalene BPO gel once daily in the evening for 12 weeks

Study groups in NCT01209949
Study group	Role	What they receive
Adapalene 0.1% and Benzoyl Peroxide 2.5% gel	Other	Not described Receives: Drug: Adapalene 0.1% and Benzoyl Peroxide 2.5% gel

What is being measured

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

Number of Participants Who Were a Success (Subject's Global Assessment of 'Clear' or 'Almost Clear') at Week 12
Number of participants who were a Success (Subject's Global Assessment of 'Clear or 'Almost Clear') at week 12. Subject's Global Assessment is measured on a scale (Clear, Almost Clear, Mild, Moderate, Severe, Very Severe) with Clear being best and Very Severe being worst.
Measured: 12 weeks

Secondary outcomes (2)

Percent Change From Baseline in Lesion Counts (Inflammatory, Non-inflammatory, and Total) at Week 12.
Mean percent change from baseline in lesions counts (inflammatory, non-inflammatory, and total) at week 12.
Measured: Week 12
Number of Participants With Tolerability Assessments Resulting in an Adverse Event
Number of participants with tolerability assessments resulting in an adverse event. Tolerability assessments include erythema (0 = None, 1 = Mild, 2 = Moderate, 3 = Severe); Scaling (0 = None, 1 = Mild, 2 = Moderate, 3 = Severe); Dryness (0 = None, 1 = Mild, 2 = Moderate, 3 = Severe); Stinging/Burning (0 = None, 1 = Mild, 2 = Moderate, 3 = Severe) with a score of None being best and a score of Severe being worst.
Measured: 12 weeks

Timeline

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

Oct 2010Jan 2011

First posted27 Sep 2010 (estimated)
Study startOct 2010
Primary completionJan 2011
Study completionJan 2011

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 4
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01209949
Sponsor's protocol ID: US10179
Status last verified: Jan 2012
First submitted: 24 Sep 2010
Last updated: 1 Aug 2022
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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Study at a glance

From the registry record, last updated by the sponsor on 1 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Assessment of Subjects' Efficacy and Experiences Using Adapalene BPO Gel in the Treatment of Acne Vulgaris
ClinicalTrials.gov ID: NCT01209949
Acronym / sponsor ID: US10179
Conditions: Acne Vulgaris
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 30 participants (actual)
Lead sponsor: Galderma R&DIndustry (pharma, biotech, devices)
Study start: Oct 2010
Primary completion: Jan 2011 (actual)
Study completion: Jan 2011 (actual)
First posted: 27 Sep 2010 (estimated)
Results: Posted 19 Jan 2012

Clinical summary

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

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Adapalene 0.1% and Benzoyl Peroxide 2.5% gel	Other	Drug: Adapalene 0.1% and Benzoyl Peroxide 2.5% gel

Who may qualify

Ages: 16 to 25 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult

Key inclusion criteria (5 listed)

Male or female subjects, aged 16 to 25 years inclusive;
Subjects with mild or moderate facial acne (Investigator's Global Assessment (IGA) = 2 or 3;
A minimum of 10 inflammatory lesions (papules and pustules) on the face (excluding the nose);
Subjects who agree to be photographed at each visit;
Subjects who agree to be video recorded by study designated staff members. They should be able to clearly and comfortably communicate their responses to questions and express their thoughts related to their disease and treatment throughout the study

Key exclusion criteria (6 listed)

Subjects with nodules, cysts, acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne, etc.) or severe acne requiring systemic treatment;
Subjects with a wash-out period for topical acne treatment on the face less than 30 days
Subjects with a wash-out period for systemic acne treatment less than 30 days with the exception of isotretinoin which requires a washout of 4 months;
Subjects who are currently being treated with antibiotics;
Subjects who foresee intensive ultraviolet (UV) exposure during the study (mountain sports, UV radiation, sunbathing, tanning beds, 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 0.1% and Benzoyl Peroxide 2.5% gelAlso: Epiduo® GelApply adapalene BPO gel once daily in the evening for 12 weeks	Drug	Adapalene 0.1% and Benzoyl Peroxide 2.5% gel

Primary outcome

Number of Participants Who Were a Success (Subject's Global Assessment of 'Clear' or 'Almost Clear') at Week 12
Time frame: 12 weeks
Number of participants who were a Success (Subject's Global Assessment of 'Clear or 'Almost Clear') at week 12. Subject's Global Assessment is measured on a scale (Clear, Almost Clear, Mild, Moderate, Severe, Very Severe) with Clear being best and Very Severe being worst.

2 secondary outcomes

Percent Change From Baseline in Lesion Counts (Inflammatory, Non-inflammatory, and Total) at Week 12.
Time frame: Week 12
Number of Participants With Tolerability Assessments Resulting in an Adverse Event
Time frame: 12 weeks

Results and safety

Results posted to the registry on 19 Jan 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% and Benzoyl Peroxide 2.5% Gel	30	27

Primary outcome: Number of Participants Who Were a Success (Subject's Global Assessment of 'Clear' or 'Almost Clear') at Week 12

Time frame: 12 weeks. Number. Unit: participants

Measure	Adapalene 0.1% and Benzoyl Peroxide 2.5% Gel n = 27
Value	18

Population analysed: Modified ITT (subjects with a baseline and week 12 visit)

2 secondary outcomes are 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% and Benzoyl Peroxide 2.5% Gel	0 of 30 (0%)	0 of 30 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2022.
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
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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.

Ronald W Gottschalk, MD study director

Galderma R&D

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

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Adapalene 0.1% and Benzoyl Peroxide 2.5% gel in people with Acne Vulgaris, run by Galderma R&D at 1 site in United States.

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 5 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 1 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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 19 Jan 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?

Number of Participants Who Were a Success (Subject's Global Assessment of 'Clear' or 'Almost Clear') at Week 12 (time frame: 12 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 NCT01209949.

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 1 Aug 2022.