Safety Study for Future Treatment of PsoriasisPhase 1NCT02976779
A Phase I, Double Blind, Randomized, Placebo Controlled, Maximal Dose Study to Determine the Safety, Tolerability of Topical Cream Containing MGC (Medical Grade Cannabis) in Healthy Volunteers
A Phase 1 study testing OWC MGC cream in people with Safety Study for Future Treatment of Psoriasis, run by One World Cannabis Ltd. at 1 site in Israel.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Safety Study for Future Treatment of Psoriasis
- What is being tested?
- OWC MGC cream
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 1 siteIsrael
- Study dates
- 3 Feb 2017to 25 Jan 2019
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Alanine aminotransferase (ALT), alkaline phosphatase and bilirubin <=1.5xupper limit of normal (ULN) (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%).
- Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and electrocardiogram (ECGs).
- A subject with a clinical abnormality or laboratory parameters outside the reference range for the population being studied may be included only if the Investigator and the OWC Medical Monitor agree that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures.
- Subjects with hemoglobin (Hb) values higher than ULN the normal range should always be excluded from enrollment.
- A female subject is eligible to participate if she is of non-childbearing potential (postmenopausal or pre-menopausal females with a documented tubal ligation or hysterectomy). Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the contraception methods in the protocol.
- Male subjects with female partners of child-bearing potential must agree to use one of the contraception methods listed in the protocol.
- Agree not to participate in any other interventional clinical trials during the study
- Agree to follow study instructions meticulously
Who cannot join
- A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening.
- Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
- Have evidence of significant, uncontrolled hematological, endocrine, cerebrovascular, cardiovascular, coronary, pulmonary, gastrointestinal, or neurological disease. (Participants with hypothyroidism who are on adequate and stable thyroid replacement will not be excluded).
- History of malignancy within 5 years of Screening or those with a strong family history of cancer (e.g., familial cancer disorders), with the exception of squamous cell or basal cell carcinoma of the skin that has been definitively treated.
- A history of drug or alcohol abuse, or a history of regular alcohol consumption within 6 months of the study defined as an average weekly intake of >14 drinks for males or >7 drinks for females. One drink is equivalent to 12 gram of alcohol: 12 ounces (360 mililiter [mL]) of beer, 5 ounces (150 mL) of wine or 1.5 ounces (45 mL) of 80 proof distilled spirits.
- Consumption of: Barbiturates, Cocaine, Ethanol, SSRI's, Protease inhibitors, Warfarin, Sildenafil, Theophilline, Tricyclic antidepressants
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- A positive test for human immunodeficiency virus (HIV) antibody.
- The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 30 days, 5 half-lives (whichever is longer).
- Unable to refrain from the use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to the first dose of study medication, unless in the opinion of the Investigator and OWC Medical Monitor the medication will not interfere with the study procedures or compromise subject safety.
- History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the investigator or OWC Medical Monitor, contraindicates their participation.
- Pregnant females as determined by positive urine human chorionic gonadotropin test at screening or prior to dosing.
- Are pregnant or nursing, or of child bearing potential and not practicing an effective means of birth control.
- Are not able to give adequate informed consent.
- Have any current problem or a history of substance abuse which, in the opinion of the investigator, might interfere with participation in the protocol.
- Have used marijuana within a month of starting the study.
- Fail the initial urine drug screen and blood test which tests for illicit drug use within the prior month.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
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).
- Being tested
- OWC MGC cream, OWC Control Cream
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OWC MGC creamDrug
Also called OWC psoriasis cream
Topical cream containing 3% CBD and 3% THC for Psoriasis treatment
OWC Control CreamDrug
Topical Cream without active ingredients
| Study group | Role | What they receive |
|---|---|---|
| OWC MGC cream | Experimental | Cannabis based topical cream 3% CBD and 3% THC. The cream was designed to treat Psoriasis . The cream will be applied twice daily. Receives: Drug: OWC MGC cream |
| OWC Control Cream | Placebo comparator | Carrier cream. CBD and THC were taken out from the formulation. The cream will be applied twice daily. Receives: Drug: OWC Control Cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence rate of AEs/ SAEs
Collection of Adverse events and Serious Adverse Events
Measured: 24 hours
Incidence rate of AEs/ SAEs
Collection of Adverse events and Serious Adverse Events
Measured: 6 weeks
Secondary outcomes (2)
Specific AEs/ SAEs
Erythema Edema Swelling Itching Heat Pain Cellulitis Other
Measured: Baseline to 24 hours
Specific AEs/ SAEs
Erythema Edema Swelling Itching Heat Pain Cellulitis Other
Measured: baseline to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2016 (estimated)
- Study start3 Feb 2017
- Primary completion25 Jan 2019
- Study completion25 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Safety Study for Future Treatment of PsoriasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- One World Cannabis Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02976779
- Sponsor's protocol ID
- OWC-PSO-01
- Status last verified
- Jan 2019
- First submitted
- 25 Nov 2016
- Last updated
- 13 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Double Blind, Randomized, Placebo Controlled, Maximal Dose Study to Determine the Safety, Tolerability of Topical Cream Containing MGC (Medical Grade Cannabis) in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT02976779
- Acronym / sponsor ID
- OWC-PSO-01
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- One World Cannabis Ltd.Industry (pharma, biotech, devices)
- Study start
- 3 Feb 2017 (actual)
- Primary completion
- 25 Jan 2019 (actual)
- Study completion
- 25 Jan 2019 (actual)
- First posted
- 29 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OWC MGC cream | Experimental | Drug: OWC MGC creamCannabis based topical cream 3% CBD and 3% THC. The cream was designed to treat Psoriasis . The cream will be applied twice daily. |
| OWC Control Cream | Placebo comparator | Drug: OWC Control CreamCarrier cream. CBD and THC were taken out from the formulation. The cream will be applied twice daily. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Alanine aminotransferase (ALT), alkaline phosphatase and bilirubin <=1.5xupper limit of normal (ULN) (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%).
- Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and electrocardiogram (ECGs).
- A subject with a clinical abnormality or laboratory parameters outside the reference range for the population being studied may be included only if the Investigator and the OWC Medical Monitor agree that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures.
- Subjects with hemoglobin (Hb) values higher than ULN the normal range should always be excluded from enrollment.
- A female subject is eligible to participate if she is of non-childbearing potential (postmenopausal or pre-menopausal females with a documented tubal ligation or hysterectomy). Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the contraception methods in the protocol.
Key exclusion criteria (16 listed)
- A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening.
- Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
- Have evidence of significant, uncontrolled hematological, endocrine, cerebrovascular, cardiovascular, coronary, pulmonary, gastrointestinal, or neurological disease. (Participants with hypothyroidism who are on adequate and stable thyroid replacement will not be excluded).
- History of malignancy within 5 years of Screening or those with a strong family history of cancer (e.g., familial cancer disorders), with the exception of squamous cell or basal cell carcinoma of the skin that has been definitively treated.
- A history of drug or alcohol abuse, or a history of regular alcohol consumption within 6 months of the study defined as an average weekly intake of >14 drinks for males or >7 drinks for females. One drink is equivalent to 12 gram of alcohol: 12 ounces (360 mililiter [mL]) of beer, 5 ounces (150 mL) of wine or 1.5 ounces (45 mL) of 80 proof distilled spirits.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OWC MGC creamAlso: OWC psoriasis creamTopical cream containing 3% CBD and 3% THC for Psoriasis treatment | Drug | OWC MGC cream |
| OWC Control CreamTopical Cream without active ingredients | Drug | OWC Control Cream |
Primary outcome
Incidence rate of AEs/ SAEs
Time frame: 24 hours
Collection of Adverse events and Serious Adverse Events
Incidence rate of AEs/ SAEs
Time frame: 6 weeks
Collection of Adverse events and Serious Adverse Events
2 secondary outcomes
Specific AEs/ SAEs
Time frame: Baseline to 24 hours
Specific AEs/ SAEs
Time frame: baseline to 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2019.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing OWC MGC cream in people with Safety Study for Future Treatment of Psoriasis, run by One World Cannabis Ltd. at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence rate of AEs/ SAEs (time frame: 24 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2019.