Long-tern Study of Epiduo in Patients With Moderate to Severe Acne (ELANG)
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Acne Vulgaris |
Drug: 0.1% adapalene / 2.5% benzoyl peroxide |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Epiduo in the Long-term Treatment of Moderate to Severe Acne With or Without Concomitant Medication |
- 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
- 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 ]
| Estimated Enrollment: | 6650 |
| Study Start Date: | June 2012 |
| Estimated Study Completion Date: | June 2013 |
-
Drug: 0.1% adapalene / 2.5% benzoyl peroxide
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.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
About 6,650 patients with moderate to severe acne (Leeds grade 4-12)
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
Contacts and Locations
More Information
No publications provided
| Responsible Party: | Galderma Laboratorium GmbH |
| ClinicalTrials.gov Identifier: | NCT01618773 History of Changes |
| Other Study ID Numbers: | ELANG |
| Study First Received: | June 12, 2012 |
| Last Updated: | June 12, 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 June 18, 2013