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

Tracking Information

First Received Date ^ICMJE

October 12, 2005

Last Updated Date

May 13, 2009

Start Date ^ICMJE

September 2006

Estimated Primary Completion Date

June 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00237978 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Detailed Description

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Condition ^ICMJE

Acne Papulopustulosa

Intervention ^ICMJE

Drug: Adapalen
Radiation: VIS and wIRA

Study Arms / Comparison Groups

Active Comparator: VIS and wIRA
Active Comparator: VIS, wIRA and Adapalen
Active Comparator: Adapalen

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

September 2009

Estimated Primary Completion Date

June 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

14 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Roland Aschoff, MD

0049-351-458 ext 2007

Roland.Aschoff@mailbox.tu-dresden.de

Location Countries ^ICMJE

Germany

Administrative Information

NCT ID ^ICMJE

NCT00237978

Responsible Party

Roland Aschoff, MD, Technical University Dresden

Study ID Numbers ^ICMJE

TUD-Akne02-003

Study Sponsor ^ICMJE

Dresden University of Technology

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Roland Aschoff, MD

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

Information Provided By

Dresden University of Technology

Verification Date

May 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP