Ongoing Studies
Actinic Keratosis Study
(Galderma, 14 Weeks)
(Galderma, 14 Weeks)
Sadick Research Group is conducting a clinical study of adult with actinic keratosis using a combination of phototherapy and topical
Study Details
Phase: 3
Gender: Male and Female
Minimum Age: 18 Years Old
Maximum Age: N/A
Facility Type: Outpatient
Stipend Range: $50 per visit
Study Length: 14 weeks
Sponsor: Galderma
Study Description
- This is a randomized, double-blind, vehicle-controlled, multicenter, parallel-group study in adult subjects with clinically-confirmed mild to moderate AKs on the face and the balding scalp, to be conducted at approximately 60 clinical sites in the United States. Sites will be selected to ensure that diverse daylight conditions will be represented in the study to understand the effects of latitude, elevation, and climate.After a screening visit, approximately 465 subjects will be randomized in a 2:1 ratio to receive 2 treatments of daylight photodynamic therapy (DL-PDT) with either MAL cream 16.8% (CD06809-41) or a vehicle cream. The 2 treatments will occur at least 2 weeks up to 4 weeks apart, Visit 2 (first DL-PDT) and Visit 4 (second DL-PDT). Other study visits will occur 1 week after each of the PDT treatments (Visits 3 and 5) for safety assessments and 12 weeks after the last DL-PDT treatment (Visit 6) for efficacy and safety assessments.
Inclusion and Exclusion Criteria
- Subjects aged ≥ 18 years at the Screening visit
- Subjects have at least 4, but no more than 12, clinically-confirmed thin or moderately thick (Grade I and II in the Olsen scale, respectively), non-hyperkeratotic, non-pigmented AKs located on the face, excluding eyelids, lips and mucosa (e.g., forehead, cheek, chin), and balding scalp
Other Trial Details
- Physical exam and assessments of study condition to be provided at no cost by an experienced provider.
- No insurance necessary.
- Compensation will be provided at the end of study participation.
