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 because the information has not been verified recently.

Verified May 2008 by Dresden University of Technology. Recruitment status was Recruiting

First Received on October 12, 2005. Last Updated on 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:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: 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:

MedlinePlus related topics: Acne

Drug Information available for: Adapalene

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
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

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

Additional relevant MeSH terms:

Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Facial Dermatoses
Sebaceous Gland Diseases
Adapalene
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics

Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Dermatologic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 09, 2012