AcneTEENANCT01220102
Efficacy of Epiduo and Treatment Adherence of Adolescent Patients With Inflammatory Acne
An observational study of Acne, run by Galderma Laboratorium GmbH.
Trial summary
The purpose of this observational study is to assess the efficacy of Epiduo and patient adherence under daily clinical practice conditions in adults and adolescents (12 to 20 years) with moderate inflammatory acne using this drug first time in topical monotherapy. Read more about this study
- Who is it for?
- Ages 12 to 20 years
- Conditions the study is for
- Acne
- What is being tested?
- 0.1% adapalene/ 2.5% benzoyl peroxide
- How many people
- 3,113 participants
- Where
- No sites listed yet
- Study dates
- May 2010to Nov 2010
- Phase
- Observational
- 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 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: About 2.700 patients with moderate inflammatory acne, aged 12 to 20 will be selected from about 324 dermatology practices
Who may be able to join
- The patient has been diagnosed with moderate inflammatory acne
- Topical monotherapy of acne with Epiduo is indicated, the decision about treating the patient with Epiduo has been made independently from this study
- The patient is aged between 12 and 20 years
Who cannot join
- Pregnancy or breastfeeding
- Hypersensitivity to the medication or any of the ingredients
- Other contraindications mentioned in the Epiduo SPC
About this study
Official title: Efficacy of Epiduo and Adherence of Patients Between 12 to 20 Years Using This Drug First Time in the Monotherapy of Moderate Inflammatory Acne
The purpose of this observational study is to assess the efficacy of Epiduo and patient adherence under daily clinical practice conditions in adults and adolescents (12 to 20 years) with moderate inflammatory acne using this drug first time in topical monotherapy.
Read the detailed description
The objective of this observational study is to assess the efficacy of Epiduo and patient adherence under daily clinical practice conditions in adults and adolescents (12 to 20 years) with moderate inflammatory acne using this drug first time in topical monotherapy. This non-interventional trial will include a larger population of teenaged acne patients in order to establish the practical contribution of a new mini-questionnaire to the evaluation of adherence for the physician in the daily clinical practice in general and in young adults topically treated with Epiduo in particular. In addition safety and local tolerability profile of Epiduo are to be assessed under marketed conditions.
- Conditions
- Acne
- Being tested
- 0.1% adapalene/ 2.5% benzoyl peroxide
- Keywords
- acne, Epiduo, adapalene/ benzoyl peroxide
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.1% adapalene/ 2.5% benzoyl peroxideDrug
Also called Epiduo
topical application, once per day
What is being measured
The primary outcome is the main question the study is designed to answer.
Severity of acne
efficacy is assessed by change in severity of acne according to the Leeds revised acne grading system
Measured: at baseline and after 12 weeks of treatment
Secondary outcomes (2)
local skin irritations
Measured: over 12 weeks
treatment adherence
treatment adherence is assessed by the physician using a mini-questionnaire recently published by the international acne expert group "Global Alliance to Improve Outcomes in Acne"
Measured: at final examination after 12 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2010 (estimated)
- Study startMay 2010
- Primary completionNov 2010
- Study completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AcneStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,113 participants (actual)
Sponsor and investigators
- Lead sponsor
- Galderma Laboratorium GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Harald PM Gollnick, Prof. Dr., Principal investigator, Universitätsklinikum Magdeburg A.ö.R Klinik für Dermatologie und Venerologie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01220102
- Sponsor's protocol ID
- TEENA
- Acronym
- TEENA
- Status last verified
- Feb 2016
- First submitted
- 12 Oct 2010
- Last updated
- 17 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Epiduo and Adherence of Patients Between 12 to 20 Years Using This Drug First Time in the Monotherapy of Moderate Inflammatory Acne
- ClinicalTrials.gov ID
- NCT01220102
- Acronym / sponsor ID
- TEENA / TEENA
- Conditions
- Acne
- Keywords
- acne, Epiduo, adapalene/ benzoyl peroxide
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,113 participants (actual)
- Lead sponsor
- Galderma Laboratorium GmbHIndustry (pharma, biotech, devices)
- Study start
- May 2010
- Primary completion
- Nov 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 13 Oct 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 observational study is to assess the efficacy of Epiduo and patient adherence under daily clinical practice conditions in adults and adolescents (12 to 20 years) with moderate inflammatory acne using this drug first time in topical monotherapy.
Detailed description
The objective of this observational study is to assess the efficacy of Epiduo and patient adherence under daily clinical practice conditions in adults and adolescents (12 to 20 years) with moderate inflammatory acne using this drug first time in topical monotherapy. This non-interventional trial will include a larger population of teenaged acne patients in order to establish the practical contribution of a new mini-questionnaire to the evaluation of adherence for the physician in the daily clinical practice in general and in young adults topically treated with Epiduo in particular. In addition safety and local tolerability profile of Epiduo are to be assessed under marketed conditions.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 12 to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- About 2.700 patients with moderate inflammatory acne, aged 12 to 20 will be selected from about 324 dermatology practices
Key inclusion criteria (3 listed)
- The patient has been diagnosed with moderate inflammatory acne
- Topical monotherapy of acne with Epiduo is indicated, the decision about treating the patient with Epiduo has been made independently from this study
- The patient is aged between 12 and 20 years
Key exclusion criteria (3 listed)
- Pregnancy or breastfeeding
- Hypersensitivity to the medication or any of the ingredients
- Other contraindications mentioned in the Epiduo SPC
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 |
|---|---|---|
| 0.1% adapalene/ 2.5% benzoyl peroxideAlso: Epiduotopical application, once per day | Drug | – |
Primary outcome
Severity of acne
Time frame: at baseline and after 12 weeks of treatment
efficacy is assessed by change in severity of acne according to the Leeds revised acne grading system
2 secondary outcomes
local skin irritations
Time frame: over 12 weeks
treatment adherence
Time frame: at final examination after 12 weeks of treatment
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 2016.
- Individual participant dataSharing planned: No
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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.
Harald PM Gollnick, Prof. Dr. principal investigator
Universitätsklinikum Magdeburg A.ö.R Klinik für Dermatologie und Venerologie
Questions about this trial
What is this clinical trial studying?
An observational study of Acne, run by Galderma Laboratorium GmbH.
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 3 inclusion and 3 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 17 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
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.
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?
Severity of acne (time frame: at baseline and after 12 weeks of treatment). 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 2016.