Acne VulgarisPUMP-itNCT02338544
Application of Epiduo(R) PUMP in Daily Practice in Patients With Inflammatory Acne
An observational study of Acne Vulgaris, run by Galderma Laboratorium GmbH.
Trial summary
The purpose of this observational trial is to assess application and convenience of Epiduo® PUMP under daily clinical practice conditions in patients with moderate to severe inflammatory acne. Read more about this study
- Who is it for?
- Ages 9 years and older
- Conditions the study is for
- Acne Vulgaris
- What is being tested?
- 0.1% Adapalene / 2.5% Benzoyl peroxide
- How many people
- 1,388 participants
- Where
- No sites listed yet
- Study dates
- Jan 2015to Sep 2015
- 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 9 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: About 2000 patients aged ≥9 years with moderate to severe inflammatory acne
Who may be able to join
- Age ≥9 years
- The patient has been diagnosed with moderate to severe inflammatory acne (Leeds Grade 4-12)
- Chest/back affected allowed, but not required
- 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
- Pregnancy or breastfeeding
- Acne inversa
- Acne with preferential manisfestation of microcysts, macrocysts and macrocomedones
- Hypersensitivity to the medication or any of the ingredients
- Other contraindications mentioned in the Epiduo® SPC
About this study
The purpose of this observational trial is to assess application and convenience of Epiduo® PUMP under daily clinical practice conditions in patients with moderate to severe inflammatory acne.
Read the detailed description
The objective of this observational trial is to assess application and convenience of Epiduo® PUMP under daily clinical practice conditions in patients with moderate to severe inflammatory acne using this drug in topical monotherapy or in combination with other drugs. In addition, efficacy of Epiduo® and incidence of adverse events will be assessed under marketed conditions. Also, patients' body beliefs will be recorded using the dysmorphic concern questionnaire.
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 up to 3 months.
- Conditions
- Acne Vulgaris
- Being tested
- 0.1% Adapalene / 2.5% 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(R) PUMP
Epiduo® gel containing 0.1% adapalene + 2.5% benzoyl peroxide dispensed from a pump.
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 up to 3 weeks of treatment
Secondary outcomes (5)
Patient-reported assessment
Patient-reported assessment of application and convenience of Epiduo PUMP
Measured: at follow-up
Physician's assessment
Overall assessment of Epiduo PUMP
Measured: at follow-up
Adherence
Patient-reported frequency of the application
Measured: at follow-up
Dysmorphic concern
Assessment of patient's body beliefs using the dysmorphic concern questionnaire
Measured: at baseline
Adverse drug reactions
Documentation of adverse drug reactions
Measured: at follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2015 (estimated)
- Study startJan 2015
- Primary completionSep 2015
- Study completionSep 2015
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
- 1,388 participants (actual)
Sponsor and investigators
- Lead sponsor
- Galderma Laboratorium GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Uwe Gieler, Prof. M.D., Principal investigator, Universitätsklinikum Gießen und Marburg GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02338544
- Sponsor's protocol ID
- PUMP-it
- Acronym
- PUMP-it
- Status last verified
- Feb 2016
- First submitted
- 12 Jan 2015
- 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
- Application of Epiduo(R) PUMP in Daily Practice in Patients With Inflammatory Acne
- ClinicalTrials.gov ID
- NCT02338544
- Acronym / sponsor ID
- PUMP-it / PUMP-it
- Conditions
- Acne Vulgaris
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,388 participants (actual)
- Lead sponsor
- Galderma Laboratorium GmbHIndustry (pharma, biotech, devices)
- Study start
- Jan 2015
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 14 Jan 2015 (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 trial is to assess application and convenience of Epiduo® PUMP under daily clinical practice conditions in patients with moderate to severe inflammatory acne.
Detailed description
The objective of this observational trial is to assess application and convenience of Epiduo® PUMP under daily clinical practice conditions in patients with moderate to severe inflammatory acne using this drug in topical monotherapy or in combination with other drugs. In addition, efficacy of Epiduo® and incidence of adverse events will be assessed under marketed conditions. Also, patients' body beliefs will be recorded using the dysmorphic concern questionnaire.
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 up to 3 months.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 9 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- About 2000 patients aged ≥9 years with moderate to severe inflammatory acne
Key inclusion criteria (4 listed)
- Age ≥9 years
- The patient has been diagnosed with moderate to severe inflammatory acne (Leeds Grade 4-12)
- Chest/back affected allowed, but not required
- 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 (5 listed)
- Pregnancy or breastfeeding
- Acne inversa
- Acne with preferential manisfestation of microcysts, macrocysts and macrocomedones
- 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: Epiduo(R) PUMPEpiduo® gel containing 0.1% adapalene + 2.5% benzoyl peroxide dispensed from a pump. | Drug | – |
Primary outcome
Severity of acne
Time frame: at baseline and after up to 3 weeks of treatment
Efficacy is assessed by change in severity of acne according to the Leeds revised grading system
5 secondary outcomes
Patient-reported assessment
Time frame: at follow-up
Physician's assessment
Time frame: at follow-up
Adherence
Time frame: at follow-up
Dysmorphic concern
Time frame: at baseline
Adverse drug reactions
Time frame: at follow-up
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
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.
Acne, Acne Papulopustulosa
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)
Acne Vulgaris
RecruitingPhase 4
Comparing Nadifloxacin Plus Tretinoin Versus Clindamycin Plus Tretinoin Creams for Mild-to-Moderate Acne
Acne Vulgaris
Active, not recruiting
Clinical Study to Evaluate the Safety and Efficacy of Candela Technology
Hair Reduction, Tattoo Removal
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.
Uwe Gieler, Prof. M.D. principal investigator
Universitätsklinikum Gießen und Marburg GmbH
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 4 inclusion and 5 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 up to 3 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.