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

June 12, 2012
June 12, 2012
June 2012
Not Provided
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
No Changes Posted
  • 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-tern 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.
 
Enrolling by invitation
6650
June 2013
Not Provided

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
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01618773
ELANG
Yes
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
June 2012

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