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

Acne Vulgaris Clinical Trial

— ELANG  

Official title:

Epiduo in the Long-term Treatment of Moderate to Severe Acne With or Without Concomitant Medication

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01618773
• Other study ID #: ELANG
• Status: Completed
• Phase: N/A
• First received: June 12, 2012
• Last updated: February 15, 2016
• Start date: June 2012
• Est. completion date: September 2013

Study information

• Verified date: February 2016
• Source: Galderma Laboratorium GmbH
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6036
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acne Vulgaris

Intervention

Drug:
• 0.1% adapalene / 2.5% benzoyl peroxide
topical application

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Galderma Laboratorium GmbH

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Severity of acne	Efficacy is assessed by change in severity of acne according to the Leeds revised grading system	at baseline and after 3 and 9 months treatment	No
Secondary	Quality of Life	Quality of life is assessed using the Cardiff Acne Disability Index	at baseline and after 3 and 9 months of treatment	No
Secondary	Treatment adherence	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"	after 3 and 9 months of treatment	No
Secondary	Local Skin Irritations		over 9 months	Yes