Efficacy of Epiduo and Treatment Adherence of Adolescent Patients With Inflammatory Acne (TEENA)
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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 |
- 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
- 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 |
-
Drug: 0.1% adapalene/ 2.5% benzoyl peroxide
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 |
About 2.700 patients with moderate inflammatory acne, aged 12 to 20 will be selected from about 324 dermatology practices
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
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 May 23, 2013