Acne VulgarisPhase 3NCT00441415
Efficacy and Safety of Fixed Combination Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel in the Treatment of Acne Vulgaris
A Phase 3 study testing Adapalene BPO in people with Acne Vulgaris, run by Galderma R&D at 4 sites in United States.
Trial summary
The purpose of this study is to demonstrate the non-inferior efficacy of Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel when compared to Clindamycin 1% / Benzoyl Peroxide 5% Gel in Subjects with acne vulgaris after a 12-week treatment period. 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
- How many people
- 272 participants
- Where
- 4 sitesUnited States
- Study dates
- Feb 2007to Oct 2007
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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
Male or female Subjects of any race, between the age of 12 and 35 years inclusive, with acne vulgaris, meeting specific inclusion/exclusion criteria.
Main inclusion criteria:
- Male or female Subjects of any race, aged 12 to 35 years inclusive, with facial acne vulgaris,
- Subjects with a minimum of 20 inflammatory lesions (papules and pustules) on the face,
- Subjects with a minimum of 30 and a maximum of 100 non-inflammatory lesions (open comedones and closed comedones) on the face, excluding the nose.
Main exclusion criteria:
- Subjects with acne cystic lesions,
- Subjects with acne conglobate, acne fulminancy, secondary acne (chloracne, drug-induced acne, etc.).
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Dr Alicia BUCKO
Albuquerque, New Mexico, 87106
Steven E. KEMPERS
Fridley, Minnesota, 55432
Elisabeth ARTHUR
Rochester, New York, 14609
Paul YAMAUCHI
Santa Monica, California, 90404
About this study
Official title: Efficacy and Safety of Fixed Combination Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel Compared to Clindamycin 0.1% / Benzoyl Peroxide 5% Gel in the Treatment of Acne Vulgaris
The purpose of this study is to demonstrate the non-inferior efficacy of Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel when compared to Clindamycin 1% / Benzoyl Peroxide 5% Gel in Subjects with acne vulgaris after a 12-week treatment period.
- Conditions
- Acne Vulgaris
- Being tested
- Adapalene BPO
- 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 BPODrug
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 (sum of non inflammatory and inflammatory lesions) at week 12.
Secondary outcomes (2)
Percent change from Baseline in total inflammatory and non inflammatory lesion counts at each intermediate visit
Global severity assessment at each post Baseline visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2007 (estimated)
- Study startFeb 2007
- Primary completionOct 2007
- Study completionOct 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Single blind
- Enrolment
- 272 participants (actual)
Sponsor and investigators
- Lead sponsor
- Galderma R&D
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Elisabeth ARTHUR, MD, Helendale Dermatology - Rochester NY - 585-266-5420Alicia BUCKO, MD, Academic Dermatology Associates - Albuquerque NM - 505-247-4220Paul YAMAUCHI, MD, Clinical Research Specialists, Inc. - Santa Monica CA - 310-828-8887Steven E. KEMPERS, MD, Minnesota Clinical Study Center - Fridley MN - 763-571-4200Harald GOLLNICK, MD, Principal investigator, Otto-von-Guericke University - Magdeburg - GermanyYvonne FRAMBACH, MD, Universitatsklinikum - Lubeck - GermanyMichael MEURER, MD, Dresden University - Dresden - GermanyChristos ZOUBOULIS, MD, Hautklinik und Immunologisches Zentrum des Städtischen Klinikum - Dessau - Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00441415
- Sponsor's protocol ID
- RD.03.SPR.29058
- Status last verified
- Aug 2008
- First submitted
- 27 Feb 2007
- Last updated
- 17 Feb 2021
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Fixed Combination Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel Compared to Clindamycin 0.1% / Benzoyl Peroxide 5% Gel in the Treatment of Acne Vulgaris
- ClinicalTrials.gov ID
- NCT00441415
- Acronym / sponsor ID
- RD.03.SPR.29058
- Conditions
- Acne Vulgaris
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 272 participants (actual)
- Lead sponsor
- Galderma R&DIndustry (pharma, biotech, devices)
- Study start
- Feb 2007
- Primary completion
- Oct 2007 (actual)
- Study completion
- Oct 2007 (actual)
- First posted
- 28 Feb 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to demonstrate the non-inferior efficacy of Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel when compared to Clindamycin 1% / Benzoyl Peroxide 5% Gel in Subjects with acne vulgaris after a 12-week treatment period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 12 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
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 | Drug | – |
Primary outcome
Percent change from Baseline in total lesion count (sum of non inflammatory and inflammatory lesions) at week 12.
2 secondary outcomes
Percent change from Baseline in total inflammatory and non inflammatory lesion counts at each intermediate visit
Global severity assessment at each post Baseline visit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2021.
- Related InfoLink provided by the sponsor.
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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.
Elisabeth ARTHUR, MD
Helendale Dermatology - Rochester NY - 585-266-5420
Alicia BUCKO, MD
Academic Dermatology Associates - Albuquerque NM - 505-247-4220
Paul YAMAUCHI, MD
Clinical Research Specialists, Inc. - Santa Monica CA - 310-828-8887
4 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 Adapalene BPO in people with Acne Vulgaris, run by Galderma R&D at 4 sites 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?
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 17 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 4 sites 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 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 (sum of non inflammatory and inflammatory lesions) at week 12.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Feb 2021.