A Skin Irritation Assessment of Once-Weekly Corplex™ Donepezil Transdermal Delivery System
Completed · Phase 1 · Has a placebo group
Conditions studied: Skin Irritation, Sensitization
In brief
A study to assess the skin irritation and sensitization potential of Corplex™ Donepezil Transdermal Delivery System (TDS)
Key facts
- Study ID
- NCT03397862
- Run by
- Corium, Inc.
- People needed
- 256
- Starts
- 2017-11-14
- Expected to finish
- 2018-04-02
- Last updated by the study team
- 2018-09-14
Who can join
Age: 40 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Healthy, adult, male or female
- Body mass index ≥ 18.0 and ≤ 35.0 kg/m2
- Medically healthy, as deemed by the Investigator
- Have a skin type with Fitzpatrick scale score of I, II, or III
You may not qualify if…
- History or presence of alcoholism or drug abuse
- History or presence of hypersensitivity or idiosyncratic reaction to the study product or related compounds
- Positive urine drug or alcohol results
- Female subjects with a positive pregnancy test or who are lactating
- Any of the following drugs, but not limited to, for 30 days prior to the first dose of study product treatment on Day 1 and throughout the study:
- Inducers of cytochrome enzymes and/or P-glycoprotein
- Anti-inflammatory drugs or cyclooxygenase 2 analgesics
- Beta-blockers
- Cholinergics and anticholinergics
- Muscle relaxants, anti-Parkinsonian, or neuroleptic medications
- History or presence of significant skin damage deemed by the investigator to potentially interfere
- Any medical or surgical procedure or trauma
- Participation in another clinical study within 30 days or 5 times the half-life of the investigational product (whichever is longer) prior to the first study product treatment
Where it is running
- Celerion Inc. — Phoenix, Arizona, United States
- Celerion Inc. — Lincoln, Nebraska, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.