Track topics on Twitter Track topics that are important to you
This single center, prospective, double-blind, placebo-controlled, randomized two parts study (part I and part II) will assess the safety of topical cream (3% CBD and 3% THC), applied twice daily (bid), in healthy subjects, for up to 6 treatment weeks and additional 2 follow-up weeks.
The study is divided into 2 stages. Healthy subjects will be consented to participate in the study.
Part I is designed to evaluate the single dose safety assessment of single application of MGC cream in 26 healthy volunteers (intact skin) for up to 24 consecutive hours under admission conditions in the clinical site. In this stage, the subjects will be divided into 3 application doses.
The following procedures will be performed:
- Time point 0- IV line, BP, Heart Rate, Blood testing (chemistry, blood count, Cannabinoids) and clinician evaluation of cannabis related psychological aspect (such as evaluation the cannabis abuse screening test).
- Time point 6 Hours- BP, Heart Rate Blood testing (chemistry, blood count, Cannabinoids)
- Time point 12- BP, Heart Rate, Blood testing (chemistry, blood count, Cannabinoids)
- Time point 24- BP, Heart Rate, Blood testing (chemistry, blood count, Cannabinoids) and and clinician evaluation of cannabis related psychological aspect (such as evaluation the cannabis abuse screening test).
Part II that will be followed the 24 hours (of part I) is designed to evaluate the repeated applications safety of MGC cream in healthy volunteers for up to 6 weeks, both in the clinic and by subjects at home.
20 healthy subjects that will be treated twice daily with:
- Maximal dose of 30 mg CBD : 30 mg THC, 1:1 ratio
- Placebo Control - 0 mg CBD : 0 mg THC, 1:1 ratio (vehicle)
This stage will be initiated at least 96 hour after completion part I of the study (washout period) .The placebo will be applied on one arm and the control on the second arm. Both, subject and investigator will be blinded as to the product/placebo allocation.
Application at home will be performed twice a day. Subjects will be asked to attend the clinic on day 0 of the part II treatment, once a week during the 6 weeks of daily application and 2 weeks post application. In each visit the following evaluations will be performed: BP, Heart Rate, Blood testing (chemistry, blood count, Cannabinoids) and clinician of cannabis related psychological aspect (such as evaluation the cannabis abuse screening test).
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment
Safety Study for Future Treatment of Psoriasis
OWC MGC cream, OWC Control Cream
Not yet recruiting
One World Cannabis Ltd.
Published on BioPortfolio: 2016-11-30T15:45:16-0500
To compare the safety and efficacy profiles of AM001 Cream, 7.5% and its vehicle cream in the treatment of plaque psoriasis
The purpose of this study is to investigate dose-response relationship, antipsoriatic efficacy and safety of different concentrations of topical formulations with AN2728 in subjects with p...
A Multi-Center, Double-Blind, Randomized, Vehicle-Controlled, Parallel-Group Study Comparing Tazarotene Cream 0.05% to TAZORAC® (tazarotene) Cream 0.05% and Both Active Treatments to a Ve...
This study will compare the efficacy and safety of once daily treatment of LEO 19123 cream versus Dovonex® cream (applied twice daily) and versus LEO 19123 cream vehicle alone (applied tw...
This study will compare the efficacy and safety of DFD-06 Cream to Vehicle Cream for topical treatment of moderate to severe plaque psoriasis after 3, 7, and 14 days of treatment.
A new improved mometasone furoate (Elocon) cream with an emulsification system that produces a stable emulsion has been developed. In order to register the product in various markets, it was essential...
Ice cream, a popular product worldwide, is usually a milk-based product with other types of ingredients (fruit, eggs, cocoa, dried fruit, additives, and others). Different materials are used to obtain...
There is currently a lack of data on the simultaneous treatment of different features of rosacea. Individually, ivermectin 1% (IVM) cream and brimonidine 0.33% (BR) gel have demonstrated efficacy on i...
Cosmetic products that contain retinyl palmitate are popular as anti-aging skin treatments; however, recent studies suggest a risk for enhanced skin tumor development with topical retinyl palmitate ap...
Objective: To evaluate the speed of onset and duration of relief of two ceramide-containing formulations with 1% pramoxine hydroxide (CeraVe® Itch Relief Lotion and Cream,Valeant Pharmaceuticals Nort...
A frozen dairy food made from cream or butterfat, milk, sugar, and flavorings. Frozen custard and French-type ice creams also contain eggs.
A synthetic, non-steroidal estrogen structurally related to stilbestrol. It is used, usually as the cream, in the treatment of menopausal and postmenopausal symptoms.
A glucocorticoid derivative used topically in the treatment of various skin disorders. It is usually employed as a cream, gel, lotion, or ointment. It has also been used topically in the treatment of inflammatory eye, ear, and nose disorders. (From Martindale, The Extra Pharmacopoeia, 30th ed, p732)
A corticosteroid used topically in the treatment of various skin disorders. It is usually employed as a cream or an ointment, and is also used as a polyethylene tape with an adhesive. (From Martindale, The Extra Pharmacopoeia, 30th ed, p733)
The clarified portion of milk, cream, or butter obtained by the removal of the nonfat constituents. (from Dictionary of Food Ingredients, 4th ed., 2001)