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Control of Therapy of Acne Papulopustulosa by Visible Light With Waterfiltered Infrared and / or Adapalen (Differin Gel)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00237978
Recruitment Status : Unknown
Verified May 2008 by Technische Universität Dresden.
Recruitment status was:  Recruiting
First Posted : October 13, 2005
Last Update Posted : May 14, 2009
Sponsor:
Information provided by:
Technische Universität Dresden

Tracking Information
First Submitted Date  ICMJE October 12, 2005
First Posted Date  ICMJE October 13, 2005
Last Update Posted Date May 14, 2009
Study Start Date  ICMJE September 2006
Estimated Primary Completion Date June 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 22, 2008)
reduction of inflammatory and non-inflammatory lesions within 8 weeks after start of therapy
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Control of Therapy of Acne Papulopustulosa by Visible Light With Waterfiltered Infrared and / or Adapalen (Differin Gel)
Official Title  ICMJE Control of Therapy of Acne Papulopustulosa by Visible Light With Waterfiltered Infrared and / or Adapalen (Differin Gel)
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 Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Acne Papulopustulosa
Intervention  ICMJE
  • Drug: Adapalen
  • Radiation: VIS and wIRA
Study Arms  ICMJE
  • Active Comparator: 1
    VIS and wIRA
    Intervention: Radiation: VIS and wIRA
  • Active Comparator: 2
    VIS, wIRA and Adapalen
    Interventions:
    • Drug: Adapalen
    • Radiation: VIS and wIRA
  • Active Comparator: 3
    Adapalen
    Intervention: Drug: Adapalen
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: April 10, 2007)
60
Original Enrollment  ICMJE Not Provided
Estimated Study Completion Date  ICMJE September 2009
Estimated Primary Completion Date June 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 14 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00237978
Other Study ID Numbers  ICMJE TUD-Akne02-003
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Roland Aschoff, MD, Technical University Dresden
Original Responsible Party Not Provided
Current Study Sponsor  ICMJE Technische Universität Dresden
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Roland Aschoff, MD Technische Universität Dresden, Fetscher Str. 74, 01307 Dresden, Germany
PRS Account Technische Universität Dresden
Verification Date May 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP