HealthyPhase 1NCT01863160
Safety and Tolerability Study of ZEP-3 Cream (0.1% and 1.0%), Administered Topically In Healthy Volunteers
A Phase 1 study testing 0.1% ZEP-3 cream in people with Healthy, run by Shulov Innovate for Science Ltd. 2012 at 1 site in Israel.
Trial summary
It is a phase I randomized, double blind, placebo-controlled, dose-escalating study to assess safety, tolerability and pharmacokinetics (PK) data of 0.1% and 1.0% ZEP-3 cream, administered topically up to 5 consecutive treatment days in healthy volunteers. This is a single center trial. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- 0.1% ZEP-3 cream
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 1 siteIsrael
- Study dates
- Jul 2013to Feb 2014
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subject must voluntarily sign and date the written Informed Consent prior to any study specific procedures
- Subject, either men or women is between 18 and 50 years of age.
- Subject, Body mass index (BMI) is within the normal to overweight range (See appendix 2)
- Subject must have healthy skin on which reddening can be easily recognized in the area where they will place the test article
- Subject must be free from a condition/disease that the investigator feels interferes with the interpretation of the study results.
- Subject is willing to participate in the study and adhere to the study protocol
- Females of childbearing potential should either be surgically sterile, or should use a highly effective medically accepted contraceptive regimen.
Who cannot join
- Subject has hyper- or hypo-pigmentation, or tattoos in the area where they will place the test fields
- Dark skinned persons whose skin color prevents ready assessment of skin reactions
- Subject with history of skin disorders or any active skin condition involving the test fields including but not limited to bacterial, viral, or fungal skin infections, acne, rosacea
- UV therapy or significant UV exposure in the four weeks before treatment application
- Subject with renal failure (Cr > 2 mg/dl) or Subject with impaired hepatic function (ALT, AST 2-fold higher than normal upper limit value).
- Cardiac disease, including recent myocardial infarction, any degree of heart block or other cardiac arrhythmias and valvular heart disease
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- Subject suffers from an autoimmune disease (Diabetes, Lupus. Chron ect.)
- History of malignancy
- Sever illness or surgery within the previous 3 months (except for minor cosmetic or dental procedures)
- Treatment with any investigational agent in another clinical trial within 1 month prior to start of this study.
- Female subject who is pregnant , lactating, or with a positive pregnancy test
- History of drug or alcohol abuse (as defined by the Investigator)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I, Randomized, Double-Blind, Placebo-Controlled, Dose-escalating Study to Assess Safety, Tolerability and Pharmacokinetics of 0.1% and 1.0% ZEP-3 Cream, Administered Topically in Healthy Volunteers.
It is a phase I randomized, double blind, placebo-controlled, dose-escalating study to assess safety, tolerability and pharmacokinetics (PK) data of 0.1% and 1.0% ZEP-3 cream, administered topically up to 5 consecutive treatment days in healthy volunteers.
This is a single center trial. It is anticipated that the study will be conducted at the Department of Dermatology, at the Sheba Medical Center, Ramat Gan, Israel.
The screening/enrollment visit includes a PK study for 24h following a single IP topical application. After a 24h washout time break, the subject will enter the treatment period for 5 consecutive treatment days followed by a follow up visit 1 and 5 days after end of treatment.
Read the detailed description
The primary endpoints of this study are:
- Safety evaluation - To demonstrate ZEP-3 cream safety in terms of skin irritation score.
- Safety evaluation - To demonstrate ZEP-3 cream safety in terms of type and severity of reported adverse events.
- Tolerability evaluation - To demonstrate ZEP-3 cream tolerability in terms of treatment compliance by the treated volunteers.
The secondary endpoints of this study are:
- Systemic absorption PK profile.
- Dermal absorption PK profile (Optional).
Subject safety will be assessed following treatment by ZEP-3 cream, using measurements of the following variables:
- Dermal reaction parameters
- Physical examination
- Vital Signs (HR, BP, RR, Body temperature)
- 12 lead ECG data
- Laboratory tests (CBC, blood chemistry, coagulation functions, urinalysis)
- Adverse events recording
- Change in concomitant medications
- Conditions
- Healthy
- Being tested
- 0.1% ZEP-3 cream, placebo
- Keywords
- Safety, Tolerability, Pharmacokinetic profile, ZEP-3 Cream (0.1% and 1.0%), administered topically
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.1% ZEP-3 creamDrug
Also called novel synthetic peptide
Topical application of 250mg ZEP-3 cream (0.1%) vs. placebo 4 times daily The IP is applied to "in advanced" demarcated sites in a dose escalating mode to 3 different treatment area sizes: small area of 2x1 cm (2 cm2), medium area of 2x5 cm (10 cm2), and large area of 4x5 cm (20 cm2).
The IP ZEP-3 cream will be applied on both ventral forearms (one application site per forearm) in a non-occlusive mode, spread and rubbed over the demarcated area.
- Right arm, single treatment area - ZEP-3 (0.1%)
- Left arm, single treatment area - Placebo cream
placeboDrug
Also called novel synthetic peptide
Topical application of 250mg ZEP-3 cream (1.0%) vs. placebo 4 times daily The IP is applied to "in advanced" demarcated sites in a dose escalating mode to 3 different treatment area sizes: small area of 2x1 cm (2 cm2), medium area of 2x5 cm (10 cm2), and large area of 4x5 cm (20 cm2).
The IP ZEP-3 cream will be applied on both ventral forearms (one application site per forearm) in a non-occlusive mode, spread and rubbed over the demarcated area.
Right arm, single treatment area - ZEP-3 (1.0%)
Left arm, single treatment area - Placebo cream
| Study group | Role | What they receive |
|---|---|---|
| 0.1% ZEP-3 cream | Other | 250 mg of ZEP-3 Cream 0.1% is applied on the right ventral forearm and 250 mg placebo is applied on the left ventral forearm 4 times daily Receives: Drug: 0.1% ZEP-3 cream |
| placebo | Other | 250 mg of ZEP-3 Cream 1.0% is applied on the right ventral forearm and 250 mg placebo is applied on the left ventral forearm 4 times daily Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Topical skin safety evaluation
Skin irritation
Measured: Change in skin clinical presentation up to 5 consecutive treatment days
Secondary outcomes (1)
Systemic absorption
PK profile
Measured: During 24 hours following initial application
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2013 (estimated)
- Study startJul 2013
- Primary completionJan 2014
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shulov Innovate for Science Ltd. 2012
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Aviv Barzily, PhD, Principal investigator, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01863160
- Sponsor's protocol ID
- ZEP - 001 - IL
- Status last verified
- Aug 2013
- First submitted
- 13 May 2013
- Last updated
- 20 Feb 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Randomized, Double-Blind, Placebo-Controlled, Dose-escalating Study to Assess Safety, Tolerability and Pharmacokinetics of 0.1% and 1.0% ZEP-3 Cream, Administered Topically in Healthy Volunteers.
- ClinicalTrials.gov ID
- NCT01863160
- Acronym / sponsor ID
- ZEP - 001 - IL
- Conditions
- Healthy
- Keywords
- Safety, Tolerability, Pharmacokinetic profile, ZEP-3 Cream (0.1% and 1.0%), administered topically
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Shulov Innovate for Science Ltd. 2012Industry (pharma, biotech, devices)
- Study start
- Jul 2013
- Primary completion
- Jan 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 27 May 2013 (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.
It is a phase I randomized, double blind, placebo-controlled, dose-escalating study to assess safety, tolerability and pharmacokinetics (PK) data of 0.1% and 1.0% ZEP-3 cream, administered topically up to 5 consecutive treatment days in healthy volunteers.
This is a single center trial. It is anticipated that the study will be conducted at the Department of Dermatology, at the Sheba Medical Center, Ramat Gan, Israel.
The screening/enrollment visit includes a PK study for 24h following a single IP topical application. After a 24h washout time break, the subject will enter the treatment period for 5 consecutive treatment days followed by a follow up visit 1 and 5 days after end of treatment.
Detailed description
The primary endpoints of this study are:
- Safety evaluation - To demonstrate ZEP-3 cream safety in terms of skin irritation score.
- Safety evaluation - To demonstrate ZEP-3 cream safety in terms of type and severity of reported adverse events.
- Tolerability evaluation - To demonstrate ZEP-3 cream tolerability in terms of treatment compliance by the treated volunteers.
The secondary endpoints of this study are:
- Systemic absorption PK profile.
- Dermal absorption PK profile (Optional).
Subject safety will be assessed following treatment by ZEP-3 cream, using measurements of the following variables:
- Dermal reaction parameters
- Physical examination
- Vital Signs (HR, BP, RR, Body temperature)
- 12 lead ECG data
- Laboratory tests (CBC, blood chemistry, coagulation functions, urinalysis)
- Adverse events recording
- Change in concomitant medications
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 0.1% ZEP-3 cream | Other | Drug: 0.1% ZEP-3 cream250 mg of ZEP-3 Cream 0.1% is applied on the right ventral forearm and 250 mg placebo is applied on the left ventral forearm 4 times daily |
| placebo | Other | Drug: placebo250 mg of ZEP-3 Cream 1.0% is applied on the right ventral forearm and 250 mg placebo is applied on the left ventral forearm 4 times daily |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Subject must voluntarily sign and date the written Informed Consent prior to any study specific procedures
- Subject, either men or women is between 18 and 50 years of age.
- Subject, Body mass index (BMI) is within the normal to overweight range (See appendix 2)
- Subject must have healthy skin on which reddening can be easily recognized in the area where they will place the test article
- Subject must be free from a condition/disease that the investigator feels interferes with the interpretation of the study results.
Key exclusion criteria (12 listed)
- Subject has hyper- or hypo-pigmentation, or tattoos in the area where they will place the test fields
- Dark skinned persons whose skin color prevents ready assessment of skin reactions
- Subject with history of skin disorders or any active skin condition involving the test fields including but not limited to bacterial, viral, or fungal skin infections, acne, rosacea
- UV therapy or significant UV exposure in the four weeks before treatment application
- Subject with renal failure (Cr > 2 mg/dl) or Subject with impaired hepatic function (ALT, AST 2-fold higher than normal upper limit value).
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 |
|---|---|---|
| 0.1% ZEP-3 creamAlso: novel synthetic peptideTopical application of 250mg ZEP-3 cream (0.1%) vs. placebo 4 times daily The IP is applied to "in advanced" demarcated sites in a dose escalating mode to 3 different treatment area sizes: small area of 2x1 cm (2 cm2), medium area of 2x5 cm (10 cm2), and large area of 4x5 cm (20 cm2). The IP ZEP-3 cream will be applied on both ventral forearms (one application site per forearm) in a non-occlusive mode, spread and rubbed over the demarcated area. * Right arm, single treatment area - ZEP-3 (0.1%) * Left arm, single treatment area - Placebo cream | Drug | 0.1% ZEP-3 cream |
| placeboAlso: novel synthetic peptideTopical application of 250mg ZEP-3 cream (1.0%) vs. placebo 4 times daily The IP is applied to "in advanced" demarcated sites in a dose escalating mode to 3 different treatment area sizes: small area of 2x1 cm (2 cm2), medium area of 2x5 cm (10 cm2), and large area of 4x5 cm (20 cm2). The IP ZEP-3 cream will be applied on both ventral forearms (one application site per forearm) in a non-occlusive mode, spread and rubbed over the demarcated area. Right arm, single treatment area - ZEP-3 (1.0%) Left arm, single treatment area - Placebo cream | Drug | placebo |
Primary outcome
Topical skin safety evaluation
Time frame: Change in skin clinical presentation up to 5 consecutive treatment days
Skin irritation
1 secondary outcome
Systemic absorption
Time frame: During 24 hours following initial application
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 20 Feb 2014.
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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.
Aviv Barzily, PhD principal investigator
Sheba Medical Center
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 0.1% ZEP-3 cream in people with Healthy, run by Shulov Innovate for Science Ltd. 2012 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 7 inclusion and 12 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 20 Feb 2014. 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. 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?
Topical skin safety evaluation (time frame: Change in skin clinical presentation up to 5 consecutive treatment days). 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 20 Feb 2014.