Acne VulgarisELANGNCT01618773
Long-term Study of Epiduo in Patients With Moderate to Severe Acne
An observational study of Acne Vulgaris, run by Galderma Laboratorium GmbH.
Trial summary
This observational study is designed to assess the long-term efficacy and safety of Epiduo (alone or in combination with other drugs) under daily clinical practice conditions in patients with moderate to severe inflammatory acne. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Acne Vulgaris
- What is being tested?
- 0.1% adapalene / 2.5% benzoyl peroxide
- How many people
- 6,036 participants
- Where
- No sites listed yet
- Study dates
- Jun 2012to Sep 2013
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: About 6,650 patients with moderate to severe acne (Leeds grade 4-12)
Who may be able to join
- The patient has been diagnosed with moderate to severe inflammatory acne (Leeds Grade 4-12)
- Topical therapy of acne with Epiduo is indicated, the decision about treating the patient with Epiduo has been made independently from this study
Who cannot join
- Use of Epiduo within 3 months prior to inclusion
- Pregnancy or breastfeeding
- Acne inversa
- Acne with preferential manifestation of microcysts, macrocysts and macrocomedones
- Hypersensitivity to the drug or any of its ingredients
- If applicable, other restrictions outlined in the SPC of Epiduo
About this study
Official title: Epiduo in the Long-term Treatment of Moderate to Severe Acne With or Without Concomitant Medication
This observational study is designed to assess the long-term efficacy and safety of Epiduo (alone or in combination with other drugs) under daily clinical practice conditions in patients with moderate to severe inflammatory acne. In addition, the effect of Epiduo on quality of life and patient adherence will be assessed under marketed conditions.
Read the detailed description
This observational study is designed to assess the long-term efficacy and safety of Epiduo under daily clinical practice conditions. The study includes patients of all ages with moderate to severe inflammatory acne, taking Epiduo alone or in combination with other drugs. In addition, the effect of Epiduo alone or in combination with other drugs on quality of life and patient adherence will be assessed under marketed conditions.
The observational study is designed as a multicentre study, covering all parts of Germany. Participating investigators are dermatologists with an adequate patient pool of acne patients. The observation time per patient will be 9 months. An interim and final examination with subsequent documentation are designated to be performed about 3 and 9 months after the start of treatment, respectively.
- Conditions
- Acne Vulgaris
- 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
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 grading system
Measured: at baseline and after 3 and 9 months treatment
Secondary outcomes (3)
Quality of Life
Quality of life is assessed using the Cardiff Acne Disability Index
Measured: at baseline and after 3 and 9 months of treatment
Treatment adherence
Treatment adherence is assessed by the physician using a mini-questionnaire published by the international acne expert group "Global Alliance to Improve Outcomes in Acne"
Measured: after 3 and 9 months of treatment
Local Skin Irritations
Measured: over 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2012 (estimated)
- Study startJun 2012
- Primary completionSep 2013
- Study completionSep 2013
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 6,036 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
- NCT01618773
- Sponsor's protocol ID
- ELANG
- Acronym
- ELANG
- Status last verified
- Feb 2016
- First submitted
- 12 Jun 2012
- Last updated
- 17 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
- 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
- Epiduo in the Long-term Treatment of Moderate to Severe Acne With or Without Concomitant Medication
- ClinicalTrials.gov ID
- NCT01618773
- Acronym / sponsor ID
- ELANG / ELANG
- Conditions
- Acne Vulgaris
- Keywords
- acne, Epiduo, adapalene/ benzoyl peroxide
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 6,036 participants (actual)
- Lead sponsor
- Galderma Laboratorium GmbHIndustry (pharma, biotech, devices)
- Study start
- Jun 2012
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 13 Jun 2012 (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.
This observational study is designed to assess the long-term efficacy and safety of Epiduo (alone or in combination with other drugs) under daily clinical practice conditions in patients with moderate to severe inflammatory acne. In addition, the effect of Epiduo on quality of life and patient adherence will be assessed under marketed conditions.
Detailed description
This observational study is designed to assess the long-term efficacy and safety of Epiduo under daily clinical practice conditions. The study includes patients of all ages with moderate to severe inflammatory acne, taking Epiduo alone or in combination with other drugs. In addition, the effect of Epiduo alone or in combination with other drugs on quality of life and patient adherence will be assessed under marketed conditions.
The observational study is designed as a multicentre study, covering all parts of Germany. Participating investigators are dermatologists with an adequate patient pool of acne patients. The observation time per patient will be 9 months. An interim and final examination with subsequent documentation are designated to be performed about 3 and 9 months after the start of treatment, respectively.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- About 6,650 patients with moderate to severe acne (Leeds grade 4-12)
Key inclusion criteria (2 listed)
- The patient has been diagnosed with moderate to severe inflammatory acne (Leeds Grade 4-12)
- Topical therapy of acne with Epiduo is indicated, the decision about treating the patient with Epiduo has been made independently from this study
Key exclusion criteria (6 listed)
- Use of Epiduo within 3 months prior to inclusion
- Pregnancy or breastfeeding
- Acne inversa
- Acne with preferential manifestation of microcysts, macrocysts and macrocomedones
- Hypersensitivity to the drug or any of its ingredients
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 | Drug | – |
Primary outcome
Severity of acne
Time frame: at baseline and after 3 and 9 months treatment
Efficacy is assessed by change in severity of acne according to the Leeds revised grading system
3 secondary outcomes
Quality of Life
Time frame: at baseline and after 3 and 9 months of treatment
Treatment adherence
Time frame: after 3 and 9 months of treatment
Local Skin Irritations
Time frame: over 9 months
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 Vulgaris, 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 2 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 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 3 and 9 months 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.