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

Primary Purpose

Acne Papulopustulosa

Status
Unknown status
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
Adapalen
VIS and wIRA
Sponsored by
Technische Universität Dresden
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acne Papulopustulosa

Eligibility Criteria

14 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Universitätsklinikum Carl Gustav Carus an der Technischen Universität DresdenRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

1

2

3

Arm Description

VIS and wIRA

VIS, wIRA and Adapalen

Adapalen

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
October 12, 2005
Last Updated
May 13, 2009
Sponsor
Technische Universität Dresden
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1. Study Identification

Unique Protocol Identification Number
NCT00237978
Brief Title
Control of Therapy of Acne Papulopustulosa by Visible Light With Waterfiltered Infrared and / or Adapalen (Differin Gel)
Official Title
Control of Therapy of Acne Papulopustulosa by Visible Light With Waterfiltered Infrared and / or Adapalen (Differin Gel)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2008
Overall Recruitment Status
Unknown status
Study Start Date
September 2006 (undefined)
Primary Completion Date
June 2009 (Anticipated)
Study Completion Date
September 2009 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Technische Universität Dresden

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acne Papulopustulosa

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
VIS and wIRA
Arm Title
2
Arm Type
Active Comparator
Arm Description
VIS, wIRA and Adapalen
Arm Title
3
Arm Type
Active Comparator
Arm Description
Adapalen
Intervention Type
Drug
Intervention Name(s)
Adapalen
Intervention Type
Radiation
Intervention Name(s)
VIS and wIRA
Primary Outcome Measure Information:
Title
reduction of inflammatory and non-inflammatory lesions within 8 weeks after start of therapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Roland Aschoff, MD
Phone
0049-351-458
Ext
2007
Email
Roland.Aschoff@mailbox.tu-dresden.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roland Aschoff, MD
Organizational Affiliation
Technische Universität Dresden, Fetscher Str. 74, 01307 Dresden, Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universitätsklinikum Carl Gustav Carus an der Technischen Universität Dresden
City
Dresden
State/Province
Sachsen
ZIP/Postal Code
01307
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Roland Aschoff, MD
Phone
0049-351-458
Ext
2007
Email
Roland.Aschoff@mailbox.tu-dresden.de

12. IPD Sharing Statement

Learn more about this trial

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

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