Control of Therapy of Acne Papulopustulosa by Visible Lig... | NCT00237978

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

NCT00237978

Sponsor

Technische Universität Dresden

Status

Unknown status

Last Update Posted

May 14, 2009Estimated

Enrollment

60Estimated

Phase

Phase 4

Conditions

Acne Papulopustulosa

Interventions

Adapalen
VIS and wIRA

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2008

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2006

Primary Completion Date

Jun 2009Estimated

Completion Date

Sep 2009Estimated

First Submitted Date

Oct 12, 2005

First Submission Date that Met QC Criteria

Oct 12, 2005

First Posted Date

Oct 13, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 13, 2009

Last Update Posted Date

May 14, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Active Comparator	VIS and wIRA	Radiation: VIS and wIRA
2	Active Comparator	VIS, wIRA and Adapalen	Drug: Adapalen Radiation: VIS and wIRA
3	Active Comparator	Adapalen	Drug: Adapalen

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Adapalen	Drug		2 3
VIS and wIRA

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
reduction of inflammatory and non-inflammatory lesions within 8 weeks after start of therapy

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

14 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Roland Aschoff, MD	Contact	0049-351-458	2007	Roland.Aschoff@mailbox.tu-dresden.de

Overall Officials

Name	Affiliation	Role
Roland Aschoff, MD	Technische Universität Dresden, Fetscher Str. 74, 01307 Dresden, Germany	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Universitätsklinikum Carl Gustav Carus an der Technischen Universität Dresden	Recruiting	Dresden	Saxony	01307	Germany