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

May 13, 2009 updated by: Technische Universität Dresden
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Germany
    • Sachsen
      • Dresden, Sachsen, Germany, 01307
        • Recruiting
        • Universitätsklinikum Carl Gustav Carus an der Technischen Universität Dresden
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: 1
VIS and wIRA
Radiation: VIS and wIRA
ACTIVE_COMPARATOR: 2
VIS, wIRA and Adapalen
Radiation: VIS and wIRA
Drug: Adapalen
ACTIVE_COMPARATOR: 3
Adapalen
Drug: Adapalen

What is the study measuring?

Primary Outcome Measures

Outcome Measure
reduction of inflammatory and non-inflammatory lesions within 8 weeks after start of therapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Technische Universität Dresden

Investigators

  • Principal Investigator: Roland Aschoff, MD, Technische Universität Dresden, Fetscher Str. 74, 01307 Dresden, Germany

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2006

Primary Completion (ANTICIPATED)

June 1, 2009

Study Completion (ANTICIPATED)

September 1, 2009

Study Registration Dates

First Submitted

October 12, 2005

First Submitted That Met QC Criteria

October 12, 2005

First Posted (ESTIMATE)

October 13, 2005

Study Record Updates

Last Update Posted (ESTIMATE)

May 14, 2009

Last Update Submitted That Met QC Criteria

May 13, 2009

Last Verified

May 1, 2008

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TUD-Akne02-003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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