Acne VulgarisPhase 4Estudo EpiduoNCT01149330
Evaluation of Efficacy and Safety of Adapalene 0.1%/Benzoyl Peroxide 2.5% Gel in the Treatment of Acne Vulgaris
A Phase 4 study testing Adapalene-BPO Gel in people with Acne Vulgaris, run by Galderma Brasil Ltda. at 6 sites in Brazil.
Trial summary
The purpose of this study is to demonstrate the efficacy of Adapalene 0.1%/Benzoyl Peroxide 2.5% Gel in the treatment of acne vulgaris. The safety will also be evaluated. 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
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 6 sitesBrazil
- Study dates
- Jul 2010to Apr 2011
- Phase
- Phase 4
- 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
Who may be able to join
- Male or female Subjects, aged 12 to 35 years inclusive, with moderate to severe facial acne vulgaris (described scale score of 3 or 4),
- Subjects with a minimum of 20 and a maximum of 50 Inflammatory Lesions (papules and pustules) on the face, excluding the nose,
- 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,
- Female Subjects of childbearing potential with a negative urine pregnancy test at the Baseline visit and must practice a highly effective method of contraception during the study: oral/systemic [injectable, patch…] contraception (must have been on a stable dose for 3 months prior to study entry), Intrauterine Device, strict abstinence, condoms, diaphragms, sponge, spermicides or partner had a vasectomy,
- Females of non-childbearing potential, i.e., premenses, post-menopausal (absence of menstrual bleeding for 2 years), hysterectomy, bilateral tubal ligation, or bilateral ovariectomy, secondary infertility and sterility are not required to have a UPT at the beginning of the study,
- Subjects have to read and sign the approved the Informed Consent form prior to any participation in the study. Subjects under the majority must sign an assent-to-participate form to participate in the study and they must have one parent or guardian read and sign the Informed Consent form prior to any study related procedure,
- Subjects willing and capable of cooperating to the extend and degree required by the protocol.
Who cannot join
- Subjects who have participated in another investigational drug or device research study within 30 days of enrollment,
- Female Subjects who are pregnant, nursing or planning a pregnancy during the study,
- Subjects with more than 1 nodule or cyst on the face
- Subjects with acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne, etc.),
- Subjects with known or suspected allergy to one of the investigational products (see package insert and/or investigator brochure),
- Subjects who have pathological conditions photosensitive porphyria, SLE, LED, solar polymorphous eruption, actinic prurigo, solar urticaria, etc.
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- Subjects with a beard or other facial hair that might interfere with study assessments,
- Subjects who foresee intensive UV exposure during the study (mountain sports, UV radiation, sunbathing, etc...)
- Female subjects with a history of hormonal changes.
- Subjects with skin condition or disease requiring topical or systemic therapy, which interferes with the investigational product or that may directly affect the evaluation criteria:
- Topical treatment for acne in the past two weeks.
- Anti-inflammatory topic in the last two weeks.
- Use of topical corticosteroids on the face in the last four weeks.
- Anti-inflammatory systemic (hormonal or not) in the last four weeks.
- Use of systemic corticosteroids in the last four weeks.
- Systemic antibiotics in the last four weeks (excluding penicillins).
- Systemic retinoids in the last six months.
- Other systemic anti-acne the last four weeks.
- Anticonceptional oral used exclusively for the control of acne in the past six months.
- Cosmetic procedures such as facials, peels, exfoliation, extraction of comedones, application of LED, laser or pulsed light in the last two weeks.
- Cosmetic procedures such as PDT in the last four weeks.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Brazil6 sites
KOLderma Instituto de Pesquisa Clínica Ltda
Campinas, São Paulo, 13020-100
Hospital De Clínicas - Universidade Federal do Paraná
Curitiba, Paraná, 80060-900
Instituo da Pele
Goiânia, Goiás, 74125-010
Instituto de Dermatologia e Estética do Brasil Ltda.
Rio de Janeiro, Rio de Janeiro, 22470-220
Serviço de Dermatologia do Ambulatório Magalhães Neto do Complexo HUPES - Universidade Federal da Bahia
Salvador, Estado de Bahia, 40110-160
Instituto de Assistência Médica ao Servidor Público Estadual
São Paulo, São Paulo, 02404-020
About this study
Official title: Evaluation of Efficacy and Safety of Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel in the Treatment of Acne Vulgaris
The purpose of this study is to demonstrate the efficacy of Adapalene 0.1%/Benzoyl Peroxide 2.5% Gel in the treatment of acne vulgaris. The safety will also be evaluated.
- Conditions
- Acne Vulgaris
- Being tested
- Adapalene-BPO Gel
- Keywords
- Adapalene, Benzoyl Peroxide, 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 GelDrug
Apply 1 gram of the investigational drug every night on whole face.
| Study group | Role | What they receive |
|---|---|---|
| Adapalene-BPO Gel | Experimental | Not described Receives: Drug: Adapalene-BPO Gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy evaluation
Changing from Baseline in Total Lesion count (Non-Inflammatory and Inflammatory lesions) in Week 12.
Measured: Week 12
Secondary outcomes (10)
Secondary efficacy evaluation
Changing from Baseline in Total Lesion count (Non-Inflammatory and Inflammatory lesions) in Week 1.
Measured: Week 1
Secondary efficacy evaluation
Changing from Baseline in Total Lesion count (Non-Inflammatory and Inflammatory lesions) in Week 2.
Measured: Week 2
Changing from Baseline in Total Lesion count (Non-Inflammatory and Inflammatory lesions) in Week 2. Secondary efficacy evaluation
Changing from Baseline in Total Lesion count (Non-Inflammatory and Inflammatory lesions) in Week 4.
Measured: Week 4
Secondary efficacy evaluation
Changing from Baseline in Total Lesion count (Non-Inflammatory and Inflammatory lesions) in Week 8.
Measured: Week 8
Secondary efficacy evaluation
Changing from Baseline in Total Lesion count (Non-Inflammatory and Inflammatory lesions) in Week 12.
Assessment of the severity of facial acne. Evaluation of global improvement at study completion. Assessment of improvement and patient satisfaction.
Measured: Week 12
Safety evaluation
Local tolerability scores - Erythema, Scaling, Dryness, Stinging/Burning at each study visit.
Measured: Week 1
Safety evaluation
Local tolerability scores - Erythema, Scaling, Dryness, Stinging/Burning at each study visit.
Measured: Week 2
Safety evaluation
Local tolerability scores - Erythema, Scaling, Dryness, Stinging/Burning at each study visit.
Measured: Week 4
Safety evaluation
Local tolerability scores - Erythema, Scaling, Dryness, Stinging/Burning at each study visit.
Measured: week 8
Safety evaluation
Local tolerability scores - Erythema, Scaling, Dryness, Stinging/Burning at each study visit.
Measured: Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2010 (estimated)
- Study startJul 2010
- Primary completionMar 2011
- Study completionApr 2011
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.
- 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
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Galderma Brasil Ltda.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Alessandra T Nogueira, MD, Study director, Galderma Brasil Ltda.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01149330
- Sponsor's protocol ID
- BR.10.001
- Acronym
- Estudo Epiduo
- Status last verified
- Mar 2012
- First submitted
- 22 Jun 2010
- Last updated
- 12 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Efficacy and Safety of Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel in the Treatment of Acne Vulgaris
- ClinicalTrials.gov ID
- NCT01149330
- Acronym / sponsor ID
- Estudo Epiduo / BR.10.001
- Conditions
- Acne Vulgaris
- Keywords
- Adapalene, Benzoyl Peroxide, Acne Vulgaris
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Galderma Brasil Ltda.Industry (pharma, biotech, devices)
- Study start
- Jul 2010
- Primary completion
- Mar 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 23 Jun 2010 (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 efficacy of Adapalene 0.1%/Benzoyl Peroxide 2.5% Gel in the treatment of acne vulgaris. The safety will also be evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adapalene-BPO Gel | Experimental | Drug: Adapalene-BPO Gel |
Who may qualify
- Ages
- 12 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Male or female Subjects, aged 12 to 35 years inclusive, with moderate to severe facial acne vulgaris (described scale score of 3 or 4),
- Subjects with a minimum of 20 and a maximum of 50 Inflammatory Lesions (papules and pustules) on the face, excluding the nose,
- 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,
- Female Subjects of childbearing potential with a negative urine pregnancy test at the Baseline visit and must practice a highly effective method of contraception during the study: oral/systemic [injectable, patch…] contraception (must have been on a stable dose for 3 months prior to study entry), Intrauterine Device, strict abstinence, condoms, diaphragms, sponge, spermicides or partner had a vasectomy,
- Females of non-childbearing potential, i.e., premenses, post-menopausal (absence of menstrual bleeding for 2 years), hysterectomy, bilateral tubal ligation, or bilateral ovariectomy, secondary infertility and sterility are not required to have a UPT at the beginning of the study,
Key exclusion criteria (21 listed)
- Subjects who have participated in another investigational drug or device research study within 30 days of enrollment,
- Female Subjects who are pregnant, nursing or planning a pregnancy during the study,
- Subjects with more than 1 nodule or cyst on the face
- Subjects with acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne, etc.),
- Subjects with known or suspected allergy to one of the investigational products (see package insert and/or investigator brochure),
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 GelApply 1 gram of the investigational drug every night on whole face. | Drug | Adapalene-BPO Gel |
Primary outcome
Efficacy evaluation
Time frame: Week 12
Changing from Baseline in Total Lesion count (Non-Inflammatory and Inflammatory lesions) in Week 12.
10 secondary outcomes
Secondary efficacy evaluation
Time frame: Week 1
Secondary efficacy evaluation
Time frame: Week 2
Changing from Baseline in Total Lesion count (Non-Inflammatory and Inflammatory lesions) in Week 2. Secondary efficacy evaluation
Time frame: Week 4
Secondary efficacy evaluation
Time frame: Week 8
Secondary efficacy evaluation
Time frame: Week 12
Safety evaluation
Time frame: Week 1
Safety evaluation
Time frame: Week 2
Safety evaluation
Time frame: Week 4
Safety evaluation
Time frame: week 8
Safety evaluation
Time frame: Week 12
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 12 Mar 2012.
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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.
Alessandra T Nogueira, MD study director
Galderma Brasil Ltda.
6 sites 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-BPO Gel in people with Acne Vulgaris, run by Galderma Brasil Ltda. at 6 sites in Brazil.
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 7 inclusion and 21 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 12 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Brazil. 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?
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?
Efficacy evaluation (time frame: 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 12 Mar 2012.