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

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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

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.

Condition or disease Intervention/treatment Phase
Acne Papulopustulosa Drug: Adapalen Radiation: VIS and wIRA Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
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)
Study Start Date : September 2006
Estimated Primary Completion Date : June 2009
Estimated Study Completion Date : September 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne
Drug Information available for: Adapalene

Arm Intervention/treatment
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



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


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Ages Eligible for Study:   14 Years and older   (Child, Adult, Older Adult)
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

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

Responsible Party: Roland Aschoff, MD, Technical University Dresden
ClinicalTrials.gov Identifier: NCT00237978     History of Changes
Other Study ID Numbers: TUD-Akne02-003
First Posted: October 13, 2005    Key Record Dates
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