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Long-term Study of Epiduo in Patients With Moderate to Severe Acne (ELANG)

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ClinicalTrials.gov Identifier: NCT01618773
Recruitment Status : Completed
First Posted : June 13, 2012
Last Update Posted : February 17, 2016
Sponsor:
Information provided by (Responsible Party):
Galderma Laboratorium GmbH

Brief 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. In addition, the effect of Epiduo on quality of life and patient adherence will be assessed under marketed conditions.

Condition or disease Intervention/treatment
Acne Vulgaris Drug: 0.1% adapalene / 2.5% benzoyl peroxide

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 Type : Observational
Actual Enrollment : 6036 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Epiduo in the Long-term Treatment of Moderate to Severe Acne With or Without Concomitant Medication
Study Start Date : June 2012
Actual Primary Completion Date : September 2013
Actual Study Completion Date : September 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne


Intervention Details:
  • Drug: 0.1% adapalene / 2.5% benzoyl peroxide
    topical application
    Other Name: Epiduo


Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Quality of Life [ Time Frame: at baseline and after 3 and 9 months of treatment ]
    Quality of life is assessed using the Cardiff Acne Disability Index

  2. Treatment adherence [ Time Frame: after 3 and 9 months of treatment ]
    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"

  3. Local Skin Irritations [ Time Frame: over 9 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
About 6,650 patients with moderate to severe acne (Leeds grade 4-12)
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

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): NCT01618773


Sponsors and Collaborators
Galderma Laboratorium GmbH
Investigators
Principal Investigator: Harald PM Gollnick, Prof. Dr. Universitätsklinikum Magdeburg A.ö.R. Klinik für Dermatologie und Venerologie

Responsible Party: Galderma Laboratorium GmbH
ClinicalTrials.gov Identifier: NCT01618773     History of Changes
Other Study ID Numbers: ELANG
First Posted: June 13, 2012    Key Record Dates
Last Update Posted: February 17, 2016
Last Verified: February 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Galderma Laboratorium GmbH:
acne
Epiduo
adapalene/ benzoyl peroxide

Additional relevant MeSH terms:
Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases
Benzoyl Peroxide
Adapalene
Adapalene, Benzoyl Peroxide Drug Combination
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