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

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ClinicalTrials.gov Identifier: NCT01220102
Recruitment Status : Completed
First Posted : October 13, 2010
Last Update Posted : February 17, 2016
Sponsor:
Information provided by (Responsible Party):
Galderma Laboratorium GmbH

Brief Summary:
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 or disease Intervention/treatment
Acne Drug: 0.1% adapalene/ 2.5% benzoyl peroxide

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.

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Study Type : Observational
Actual Enrollment : 3113 participants
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
Study Start Date : May 2010
Actual Primary Completion Date : November 2010
Actual Study Completion Date : November 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne


Intervention Details:
  • Drug: 0.1% adapalene/ 2.5% benzoyl peroxide
    topical application, once per day
    Other Name: Epiduo


Primary Outcome Measures :
  1. Severity of acne [ Time Frame: at baseline and after 12 weeks of treatment ]
    efficacy is assessed by change in severity of acne according to the Leeds revised acne grading system


Secondary Outcome Measures :
  1. local skin irritations [ Time Frame: over 12 weeks ]
  2. treatment adherence [ Time Frame: at final examination after 12 weeks of treatment ]
    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"



Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 20 Years   (Child, Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01220102


Sponsors and Collaborators
Galderma Laboratorium GmbH
Investigators
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Principal Investigator: Harald PM Gollnick, Prof. Dr. Universitätsklinikum Magdeburg A.ö.R Klinik für Dermatologie und Venerologie

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Responsible Party: Galderma Laboratorium GmbH
ClinicalTrials.gov Identifier: NCT01220102     History of Changes
Other Study ID Numbers: TEENA
First Posted: October 13, 2010    Key Record Dates
Last Update Posted: February 17, 2016
Last Verified: February 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Galderma Laboratorium GmbH:
acne
Epiduo
adapalene/ benzoyl peroxide
Additional relevant MeSH terms:
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Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases
Adapalene
Adapalene, Benzoyl Peroxide Drug Combination
Benzoyl Peroxide
Dermatologic Agents
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