Efficacy of Epiduo and Treatment Adherence of Adolescent Patients With Inflammatory Acne (TEENA)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Galderma Laboratorium GmbH
ClinicalTrials.gov Identifier:
NCT01220102
First received: October 12, 2010
Last updated: June 14, 2012
Last verified: June 2012
  Purpose

The purpose of this observational study is to assess the efficacy of Epiduo and patient adherence under daily clinical practice conditions in adults and adolescents (12 to 20 years) with moderate inflammatory acne using this drug first time in topical monotherapy.


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

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Efficacy of Epiduo and Adherence of Patients Between 12 to 20 Years Using This Drug First Time in the Monotherapy of Moderate Inflammatory Acne

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 12 weeks of treatment ] [ Designated as safety issue: No ]
    efficacy is assessed by change in severity of acne according to the Leeds revised acne grading system


Secondary Outcome Measures:
  • local skin irritations [ Time Frame: over 12 weeks ] [ Designated as safety issue: Yes ]
  • treatment adherence [ Time Frame: at final examination after 12 weeks of treatment ] [ Designated as safety issue: No ]
    treatment adherence is assessed by the physician using a mini-questionnaire recently published by the international acne expert group "Global Alliance to Improve Outcomes in Acne"


Enrollment: 3113
Study Start Date: May 2010
Study Completion Date: November 2010
Intervention Details:
    Drug: 0.1% adapalene/ 2.5% benzoyl peroxide
    topical application, once per day
    Other Name: Epiduo
Detailed Description:

The objective of this observational study is to assess the efficacy of Epiduo and patient adherence under daily clinical practice conditions in adults and adolescents (12 to 20 years) with moderate inflammatory acne using this drug first time in topical monotherapy. This non-interventional trial will include a larger population of teenaged acne patients in order to establish the practical contribution of a new mini-questionnaire to the evaluation of adherence for the physician in the daily clinical practice in general and in young adults topically treated with Epiduo in particular. In addition safety and local tolerability profile of Epiduo are to be assessed under marketed conditions.

  Eligibility

Ages Eligible for Study:   12 Years to 20 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

About 2.700 patients with moderate inflammatory acne, aged 12 to 20 will be selected from about 324 dermatology practices

Criteria

Inclusion Criteria:

  • The patient has been diagnosed with moderate inflammatory acne
  • Topical monotherapy of acne with Epiduo is indicated, the decision about treating the patient with Epiduo has been made independently from this study
  • The patient is aged between 12 and 20 years

Exclusion Criteria:

  • Pregnancy or breastfeeding
  • Hypersensitivity to the medication or any of the ingredients
  • Other contraindications mentioned in the Epiduo SPC
  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: NCT01220102

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: NCT01220102     History of Changes
Other Study ID Numbers: TEENA
Study First Received: October 12, 2010
Last Updated: June 14, 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 July 20, 2014