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

Sponsored by:	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: Differin Gel	Phase IV

MedlinePlus related topics: Acne

Drug Information available for: Adapalene

U.S. FDA Resources

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)

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)

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

Responsible Party:	Technical University Dresden ( Roland Aschoff, MD )
Study ID Numbers:	TUD-Akne02-003
Study First Received:	October 12, 2005
Last Updated:	May 22, 2008
ClinicalTrials.gov Identifier:	NCT00237978
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Study placed in the following topic categories:

Exanthema
Facial Dermatoses
Facies
Skin Diseases

Adapalene
Sebaceous Gland Diseases
Acne Vulgaris

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Physiological Effects of Drugs
Pharmacologic Actions
Acneiform Eruptions
Analgesics, Non-Narcotic
Sensory System Agents
Therapeutic Uses

Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Peripheral Nervous System Agents
Antirheumatic Agents
Dermatologic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 16, 2009