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View trial details
Overview
Official protocol title:
A PHASE 1 AND 2 RANDOMIZED, DOUBLE-BLIND, VEHICLE-CONTROLLED, PARALLEL-GROUP STUDY TO EVALUATE THE SAFETY, TOLERABILITY, EFFICACY, AND EXPOSURE OF UP TO 12 WEEKS OF XPF-005 TREATMENT IN HEALTHY VOLUNTEERS AND SUBJECTS WITH ACNE VULGARIS
Intervention/treatment:
Name given to the drug used in the clinical trial. This may be a code name, a chemical name of the active ingredient, a non-proprietary name or brand name.
XPF-005 (XEN801)
Medical condition:
The disease or condition that's being studied in the clinical trial.
Protocol code:
An alpha-numeric sequence generated by the sponsor that can vary in length. Used as a reference to help identify a specific clinical trial protocol. Formerly referred to as 'protocol number'.
XPF-005-101
Control number:
A unique 6-digit identification number Health Canada assigns to each clinical trial application.
187000
Status:
The status for the clinical trial as a whole. Note that the status for each site may be different and should always be confirmed with the clinical trial sponsor. Health Canada uses information provided by the sponsor to an international clinical trial registry to determine status values for each clinical trial. Status values on the portal can include:
• Not yet recruiting - Participants are not yet being recruited or enrolled at any site.
• Recruiting - Participants are currently being recruited.
• Active, not recruiting - The clinical trial is ongoing but new participants are not currently being recruited or enrolled.
• On hold - The clinical trial has been temporarily stopped, but it may start again.
• Closed - The clinical trial has either ended normally and participants are no longer being examined or treated, or it has stopped early and will not start again.
• Unknown - The status of the clinical trial has not been verified in the registry in the last 2 years. Please contact the sponsor.
• No match, ongoing - Please contact sponsor for status information.
• Other - Please contact sponsor for status information.
Closed
Approved:
The date that the clinical trial has been determined to meet Health Canada’s regulatory requirements. For drug clinical trials, this means that a no objection letter or an authorization was issued.
September 15, 2015
Trial phase:
The stage of a clinical trial, based on factors such as the objectives of the trial and number of participants. Phase data displayed in the portal is taken from international registry data.
For more information see "Phases of drug trials" on the Definitions webpage
Phase 1, Phase 2
For more information:
ClinicalTrials.gov -
NCT02656043
This is an external link. The information is not authorized by the Government of Canada.
Eligibility
The characteristics people must have or the requirements they must meet to participate in the clinical trial. Eligibility criteria include both inclusion criteria (must have for a person to participate) and exclusion criteria (prevent a person from participating).
Review the exact criteria from the registry or the sponsor before making a decision to participate. The following values may be available on the portal:
Sex: an eligibility criteria based on biological characteristics. Information in the portal is based on available data and will default to 'all' when no other data is available.
Age: The age a person must be to participate in the clinical trial.
Accepts Healthy Volunteers: People who do not have the disease or condition can participate in the clinical trial.
Sex:
ALL
Accepts healthy volunteers:
Yes
Locations
Alberta
Institute for Skin Advancement
Calgary, Alberta, T3A 2N1
Kirk Barber Research
Calgary, Alberta, T2G 1B1
Stratica Medical Inc.
Edmonton, Alberta, T5K 1X3
British Columbia
Carruthers & Humphrey Clinical Research
Vancouver, British Columbia, V5Z 4E1
Dr. Chih-ho Hong Medical Inc.
Surrey, British Columbia, V3R 6A7
Pacific Dermaesthetics
Vancouver, British Columbia, V6E 4M3
Manitoba
Toole Dermatology Research
Winnipeg, Manitoba, R3C 1R4
New Brunswick
Clinique Médicale Nepisiguit
Bathurst, New Brunswick, E2A 4Z9
Ontario
Bayview North Dermatology Clinic
Toronto, Ontario, M2M 4J5
DermEdge Research
Mississauga, Ontario, L5H 1G9
G. Daniel Schachter Medicine Professional Corporation
Toronto, Ontario, M5S 3B4
K. Papp Clinical Research Inc
Waterloo, Ontario, N2J 1C4
Lynderm Research Inc
Markham, Ontario, L3P 1X2
Research by ICLS
Oakville, Ontario, L6J 7W5
SimcoDerm Medical and Surgical Dermatology Center
Windsor Clinical Research Inc.
Windsor, Ontario, N8W 5L7
York Dermatology Center
Richmond Hill, Ontario, L4C 9M7
Quebec
Dre Angélique Gagné-Henley M.D. Inc
Saint-Jérôme, Quebec, J7Z 3B8
Siena Medical Research Corporation
Westmount, Quebec, H3Z 2S6
