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

Tracking Information

First Received Date ^ICMJE

June 12, 2012

Last Updated Date

June 12, 2012

Start Date ^ICMJE

June 2012

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

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 ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Cohort
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Probability Sample

Study Population

About 6,650 patients with moderate to severe acne (Leeds grade 4-12)

Condition ^ICMJE

Acne Vulgaris

Intervention ^ICMJE

Drug: 0.1% adapalene / 2.5% benzoyl peroxide

topical application

Other Name: Epiduo

Study Group/Cohort (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Enrolling by invitation

Estimated Enrollment ^ICMJE

6650

Estimated Completion Date

June 2013

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

Not Provided

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Not Provided

Administrative Information

NCT Number ^ICMJE

NCT01618773

Other Study ID Numbers ^ICMJE

ELANG

Has Data Monitoring Committee

Yes

Responsible Party

Galderma Laboratorium GmbH

Study Sponsor ^ICMJE

Galderma Laboratorium GmbH

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Harald PM Gollnick, Prof. Dr.

Universitätsklinikum Magdeburg A.ö.R. Klinik für Dermatologie und Venerologie

Information Provided By

Galderma Laboratorium GmbH

Verification Date

June 2012

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

To Top