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History of Changes for Study: NCT00237978
Control of Therapy of Acne Papulopustulosa by Visible Light With Waterfiltered Infrared and / or Adapalen (Differin Gel)
Latest version (submitted May 13, 2009) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 October 12, 2005 None (earliest Version on record)
2 April 10, 2007 Recruitment Status, Study Status, Contacts/Locations, Study Design and Oversight
3 May 22, 2008 Study Status, Study Identification, Outcome Measures, Study Design, Oversight and Sponsor/Collaborators
4 May 13, 2009 Recruitment Status, Arms and Interventions and Study Status
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Study NCT00237978
Submitted Date:  October 12, 2005 (v1)

Open or close this module Study Identification
Unique Protocol ID: Akne02
Brief Title: Control of Therapy of Acne Papulopustulosa by Visible Light With Waterfiltered Infrared and / or Adapalen (Differin Gel)
Official Title:
Secondary IDs:
Open or close this module Study Status
Record Verification: October 2005
Overall Status: Not yet recruiting
Study Start:
Primary Completion:
Study Completion:
First Submitted: October 12, 2005
First Submitted that
Met QC Criteria:
October 12, 2005
First Posted: October 13, 2005 [Estimate]
Last Update Submitted that
Met QC Criteria:
October 12, 2005
Last Update Posted: October 13, 2005 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Technische Universität Dresden
Responsible Party:
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring:
Open or close this module Study Description
Brief Summary: 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.
Detailed Description:
Open or close this module Conditions
Conditions: Acne Papulopustulosa
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 4
Interventional Study Model: Parallel Assignment
Number of Arms:
Masking: None (Open Label)
Allocation: Randomized
Enrollment:
Open or close this module Arms and Interventions
Intervention Details:
Drug: Differin Gel
Open or close this module Outcome Measures
Open or close this module Eligibility
Minimum Age: 14 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

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
Open or close this module Contacts/Locations
Central Contact Person: Roland Aschoff, MD
Telephone: 0049-351-458 Ext. 2007
Email: Roland.Aschoff@mailbox.tu-dresden.de
Study Officials: Roland Aschoff, MD
Principal Investigator
Technische Universität Dresden, Fetscher Str. 74, 01307 Dresden, Germany
Locations: Germany, Sachsen
Universitätsklinikum Carl Gustav Carus an der Technischen Universität Dresden
Dresden, Sachsen, Germany, 01307
Contact:Contact: Roland Aschoff, MD 0049-351-458 Ext. 2007 Roland.Aschoff@mailbox.tu-dresden.de
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Plan to Share IPD:
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Citations:
Links:
Available IPD/Information:

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