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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Galderma Laboratorium GmbH
ClinicalTrials.gov Identifier:
NCT01618773
First received: June 12, 2012
Last updated: February 15, 2016
Last verified: February 2016

June 12, 2012
February 15, 2016
June 2012
September 2013   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01618773 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Long-term Study of Epiduo in Patients With Moderate to Severe Acne
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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample
About 6,650 patients with moderate to severe acne (Leeds grade 4-12)
Acne Vulgaris
Drug: 0.1% adapalene / 2.5% benzoyl peroxide
topical application
Other Name: Epiduo
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
6036
September 2013
September 2013   (final data collection date for primary outcome measure)

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
Both
Child, Adult, Senior
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01618773
ELANG
Yes
No
Not Provided
Galderma Laboratorium GmbH
Galderma Laboratorium GmbH
Not Provided
Principal Investigator: Harald PM Gollnick, Prof. Dr. Universitätsklinikum Magdeburg A.ö.R. Klinik für Dermatologie und Venerologie
Galderma Laboratorium GmbH
February 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP