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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2008 by Technische Universität Dresden.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00237978
First Posted: October 13, 2005
Last Update Posted: May 14, 2009
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.
Information provided by:
Technische Universität Dresden
  Purpose
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.

Condition Intervention Phase
Acne Papulopustulosa Drug: Adapalen Radiation: VIS and wIRA Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Control of Therapy of Acne Papulopustulosa by Visible Light With Waterfiltered Infrared and / or Adapalen (Differin Gel)

Resource links provided by NLM:


Further study details as provided by Technische Universität Dresden:

Primary Outcome Measures:
  • reduction of inflammatory and non-inflammatory lesions within 8 weeks after start of therapy

Estimated Enrollment: 60
Study Start Date: September 2006
Estimated Study Completion Date: September 2009
Estimated Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
VIS and wIRA
Radiation: VIS and wIRA
Active Comparator: 2
VIS, wIRA and Adapalen
Drug: Adapalen Radiation: VIS and wIRA
Active Comparator: 3
Adapalen
Drug: Adapalen

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00237978


Contacts
Contact: Roland Aschoff, MD 0049-351-458 ext 2007 Roland.Aschoff@mailbox.tu-dresden.de

Locations
Germany
Universitätsklinikum Carl Gustav Carus an der Technischen Universität Dresden Recruiting
Dresden, Sachsen, Germany, 01307
Contact: Roland Aschoff, MD    0049-351-458 ext 2007    Roland.Aschoff@mailbox.tu-dresden.de   
Sponsors and Collaborators
Technische Universität Dresden
Investigators
Principal Investigator: Roland Aschoff, MD Technische Universität Dresden, Fetscher Str. 74, 01307 Dresden, Germany
  More Information

Responsible Party: Roland Aschoff, MD, Technical University Dresden
ClinicalTrials.gov Identifier: NCT00237978     History of Changes
Other Study ID Numbers: TUD-Akne02-003
First Submitted: October 12, 2005
First Posted: October 13, 2005
Last Update Posted: May 14, 2009
Last Verified: May 2008

Additional relevant MeSH terms:
Adapalene
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
Dermatologic Agents