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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT00237978
Other study ID # TUD-Akne02-003
Secondary ID
Status Recruiting
Phase Phase 4
First received October 12, 2005
Last updated May 13, 2009
Start date September 2006
Est. completion date September 2009

Study information

Verified date May 2008
Source Technische Universität Dresden
Contact Roland Aschoff, MD
Phone 0049-351-458
Email Roland.Aschoff@mailbox.tu-dresden.de
Is FDA regulated No
Health authority Germany: Federal Institute for Drugs and Medical Devices
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date September 2009
Est. primary completion date June 2009
Accepts healthy volunteers No
Gender Both
Age group 14 Years and older
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Adapalen

Radiation:
VIS and wIRA


Locations

Country Name City State
Germany Universitätsklinikum Carl Gustav Carus an der Technischen Universität Dresden Dresden Sachsen

Sponsors (1)

Lead Sponsor Collaborator
Technische Universität Dresden

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary reduction of inflammatory and non-inflammatory lesions within 8 weeks after start of therapy No