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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Galderma Laboratorium GmbH
ClinicalTrials.gov Identifier:
NCT01618773
First received: June 12, 2012
Last updated: NA
Last verified: June 2012
History: No changes posted
  Purpose

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 Intervention
Acne Vulgaris
Drug: 0.1% adapalene / 2.5% benzoyl peroxide

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Epiduo in the Long-term Treatment of Moderate to Severe Acne With or Without Concomitant Medication

Resource links provided by NLM:


Further study details as provided by Galderma Laboratorium GmbH:

Primary Outcome Measures:
  • Severity of acne [ Time Frame: at baseline and after 3 and 9 months treatment ] [ Designated as safety issue: No ]
    Efficacy is assessed by change in severity of acne according to the Leeds revised grading system


Secondary Outcome Measures:
  • Quality of Life [ Time Frame: at baseline and after 3 and 9 months of treatment ] [ Designated as safety issue: No ]
    Quality of life is assessed using the Cardiff Acne Disability Index

  • Treatment adherence [ Time Frame: after 3 and 9 months of treatment ] [ Designated as safety issue: No ]
    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"

  • Local Skin Irritations [ Time Frame: over 9 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 6650
Study Start Date: June 2012
Estimated Study Completion Date: June 2013
Intervention Details:
    Drug: 0.1% adapalene / 2.5% benzoyl peroxide
    topical application
    Other Name: Epiduo
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.

  Eligibility

Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Galderma Laboratorium GmbH
ClinicalTrials.gov Identifier: NCT01618773     History of Changes
Other Study ID Numbers: ELANG
Study First Received: June 12, 2012
Last Updated: June 12, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

Additional relevant MeSH terms:
Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Facial Dermatoses
Sebaceous Gland Diseases
Adapalene
Benzoyl Peroxide
Dermatologic Agents
Therapeutic Uses
Pharmacologic Actions
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
Central Nervous System Agents

ClinicalTrials.gov processed this record on September 18, 2014