The aim of the study is to investigate the effectivity of visible light in combination with waterfiltered infrared in treating acne papulopustulosa. The reduction of inflammatory and non-inflammatory lesions within 8 weeks will be measured and compared with the standard treatment with Adapalene...
Date First Received: October 12, 2005
Last Updated: May 22, 2008
Verified by: Dresden University of Technology, May 2008
Clinical Trial Phase: Phase 4 | Start Date: September 2006
Overall Status: Recruiting
Estimated Enrollment: 60
Brief Summary
Official Title: “Control of Therapy of Acne Papulopustulosa by Visible Light With Waterfiltered Infrared and / or Adapalen (Differin Gel)”
Condition Keyword(s):
Intervention(s):
The aim of the study is to investigate the effectivity of visible light in combination with waterfiltered infrared in treating acne papulopustulosa. The reduction of inflammatory and non-inflammatory lesions within 8 weeks will be measured and compared with the standard treatment with Adapalene.
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Study Primary Completion Date: June 2009
Intervention(s) in this Clinical Trial
- Drug: Differin Gel
Outcome Measures for this Clinical Trial
Primary Measures
- reduction of inflammatory and non-inflammatory lesions within 8 weeks after start of therapy
- Safety Issue?: No
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- Mild to moderate acne papulopustulosa according to Burton Scale Stage 3 to 4
- At least 5 inflammatory and 5 non-inflammatory lesions in the face
- Age >= 14 years
Exclusion Criteria:
- pregnant and nursing women
- Antiandrogen therapy
- therapy with antibiotics within the last 4 weeks
- therapy with retinoids within the last 6 months
- natural or artificial UV-therapy within the last 4 weeks
- severe acne papulopustulosa according to Burton Scale 5 or 6
- Severe systemic condition
- Secondary acne
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 14 Years
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: Dresden University of Technology
Overall Clinical Trial Officials and Contacts
Roland Aschoff, MD Principal Investigator Technische Universität Dresden, Fetscher Str. 74, 01307 Dresden, Germany
Overall Contact: Roland Aschoff, MD 0049-351-458 Roland.Aschoff@mailbox.tu-dresden.de
Additional Information
Information obtained from ClinicalTrials.gov on October 10, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00237978
Study ID Number: TUD-Akne02-003
ClinicalTrials.gov Identifier: NCT00237978
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
Clinical Trials Authorship and Review
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