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Trial record 75 of 134 for:    acne AND peroxide

Application of Epiduo(R) PUMP in Daily Practice in Patients With Inflammatory Acne (PUMP-it)

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ClinicalTrials.gov Identifier: NCT02338544
Recruitment Status : Completed
First Posted : January 14, 2015
Last Update Posted : February 17, 2016
Sponsor:
Information provided by (Responsible Party):
Galderma Laboratorium GmbH

Brief 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.

Condition or disease Intervention/treatment
Acne Vulgaris Drug: 0.1% Adapalene / 2.5% Benzoyl peroxide

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.


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Study Type : Observational
Actual Enrollment : 1388 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Application of Epiduo(R) PUMP in Daily Practice in Patients With Inflammatory Acne
Study Start Date : January 2015
Actual Primary Completion Date : September 2015
Actual Study Completion Date : September 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne


Intervention Details:
  • Drug: 0.1% Adapalene / 2.5% Benzoyl peroxide
    Epiduo® gel containing 0.1% adapalene + 2.5% benzoyl peroxide dispensed from a pump.
    Other Name: Epiduo(R) PUMP


Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Patient-reported assessment [ Time Frame: at follow-up ]
    Patient-reported assessment of application and convenience of Epiduo PUMP

  2. Physician's assessment [ Time Frame: at follow-up ]
    Overall assessment of Epiduo PUMP

  3. Adherence [ Time Frame: at follow-up ]
    Patient-reported frequency of the application

  4. Dysmorphic concern [ Time Frame: at baseline ]
    Assessment of patient's body beliefs using the dysmorphic concern questionnaire

  5. Adverse drug reactions [ Time Frame: at follow-up ]
    Documentation of adverse drug reactions



Information from the National Library of Medicine

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Ages Eligible for Study:   9 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
About 2000 patients aged ≥9 years with moderate to severe inflammatory acne
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02338544


Sponsors and Collaborators
Galderma Laboratorium GmbH
Investigators
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Principal Investigator: Uwe Gieler, Prof. M.D. Universitätsklinikum Gießen und Marburg GmbH

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Responsible Party: Galderma Laboratorium GmbH
ClinicalTrials.gov Identifier: NCT02338544     History of Changes
Other Study ID Numbers: PUMP-it
First Posted: January 14, 2015    Key Record Dates
Last Update Posted: February 17, 2016
Last Verified: February 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Acne Vulgaris
Adapalene, Benzoyl Peroxide Drug Combination
Benzoyl Peroxide
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases
Adapalene
Dermatologic Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents