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

This study is currently recruiting participants.

Verified by Dresden University of Technology, May 2008

First Received: October 12, 2005 Last Updated: May 13, 2009 History of Changes

Sponsor:	Dresden University of Technology
Information provided by:	Dresden University of Technology
ClinicalTrials.gov Identifier:	NCT00237978

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 IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Control of Therapy of Acne Papulopustulosa by Visible Light With Waterfiltered Infrared and / or Adapalen (Differin Gel)

Resource links provided by NLM:

MedlinePlus related topics: Acne

U.S. FDA Resources

Further study details as provided by Dresden University of Technology:

Primary Outcome Measures:

reduction of inflammatory and non-inflammatory lesions within 8 weeks after start of therapy [ Designated as safety issue: No ]

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
1: Active Comparator VIS and wIRA	Radiation: VIS and wIRA
2: Active Comparator VIS, wIRA and Adapalen	Drug: Adapalen Radiation: VIS and wIRA
3: Active Comparator Adapalen	Drug: Adapalen

Eligibility

Ages Eligible for Study:	14 Years and older
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00237978

Contacts

Contact: Roland Aschoff, MD

0049-351-458 ext 2007

Roland.Aschoff@mailbox.tu-dresden.de

Locations

Germany, Sachsen
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

Dresden University of Technology

Investigators

Principal Investigator:

Roland Aschoff, MD

Technische Universität Dresden, Fetscher Str. 74, 01307 Dresden, Germany

More Information

No publications provided

Responsible Party:	Technical University Dresden ( Roland Aschoff, MD )
Study ID Numbers:	TUD-Akne02-003
Study First Received:	October 12, 2005
Last Updated:	May 13, 2009
ClinicalTrials.gov Identifier:	NCT00237978 History of Changes
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:

Facial Dermatoses
Skin Diseases
Acneiform Eruptions
Sebaceous Gland Diseases
Acne Vulgaris

ClinicalTrials.gov processed this record on November 27, 2009