Effect of IDEA-070 on Pain and Inflammation Induced by PDT

IDEA AG

Status and phase: Completed; Phase 2

Conditions: Actinic Keratosis

Treatments: Drug: IDEA-070

Study type: Interventional

Funder types: Industry

Identifiers

NCT00269074

CL-070-II-02

EudrCT number: 2005-002875-34

Details and patient eligibility

About

Primary objectives: effect of IDEA-070 compared to placebo on pain and inflammation induced by PDT. The primary objective is to detect a statistically significant difference of pain and inflammation induced by PDT in test areas treated with IDEA-070 compared to placebo-treated areas.

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Diagnosis ot actinic keratosis to be treated with PDT affecting equal sized areas of both sides of the head affecting at least 10% of the area of photoexposure

Exclusion criteria

Morpheaform basal cell carcinoma, Major hypertrophy of lesions, Porphyria, Topical treatment with 5-FU, cryotherapy, PDT, diclophenac sodium, and other less common treatments on the treatment area or systemic treatment within 3 month prior to screening, Concomitant use of other analgesics including topical NSAIDs

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind