Skin ToxicityPhase 4NCT03606954
Potency of Topical Corticosteroids in Combination Preparations
A Phase 4 study testing Combination topical corticosteroid in people with Skin Toxicity, run by Ben-Gurion University of the Negev.
Trial summary
Several combination topical drugs are available on the market. The potency of corticosteroids depends on a particular molecular structure and the skin penetration properties. Besides molecular structure, a penetration of a corticosteroid molecule correlates with physical properties of the vehicle which depend on… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Skin Toxicity
- What is being tested?
- Combination topical corticosteroid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Nov 2018to Apr 2019
- Phase
- Phase 4
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- No prior history of internal diseases that required vaccine-suppressing treatments
- Absence of an active skin disease.
Who cannot join
- Treatment with topical corticosteroids in the 4 weeks prior to the study
- Immune-suppressive treatment in the 4 weeks prior to the study
- Pregnancy or breast feeding
Trial locations and contacts
No sites are listed yet.
Alex Zvulunov, MD contact
About this study
Official title: Evaluation of Topical Corticosteroids Potency in Combination Preparations in Healthy Volunteers
Several combination topical drugs are available on the market. The potency of corticosteroids depends on a particular molecular structure and the skin penetration properties. Besides molecular structure, a penetration of a corticosteroid molecule correlates with physical properties of the vehicle which depend on physical properties of the vehicle constituents.
Vasoconstriction assay is considered as the gold standard for testing potency of topical corticosteroids.
Read the detailed description
Primary outcome: Change in Vasoconstriction index following application of topical corticosteroids that are incorporated with or without an antibiotic and/or antifungal drugs in healthy volunteers.
- Conditions
- Skin Toxicity
- Being tested
- Combination topical corticosteroid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combination topical corticosteroidCombination product
Comparison of a vasoconstriction index between the 2 study arms
| Study group | Role | What they receive |
|---|---|---|
| Combination topical corticosteroid | Active comparator | The combination topical corticosteroid will be applied to specific and marked sites on the forearms (on the flexor side of the forearm- 5*5 cm with a distance of 3 cm) - two sites on both forearms of every subject (4 sites in total). The nature of this application method will enable the measurement of the level of potency of each drug, in a manner that is comparative, neutralizing thus the influence of inter-subject variability.
The drugs will be topically applied (50 microliter on each site) for 16 hours, utilizing an occlusive dressing bandage such as Tegaderm. The vasoconstriction test will be preformed both before and after drug application. The vasoconstriction in each subject will be graded on the Olsen scale Receives: Combination Product: Combination topical corticosteroid |
| Non-combination topical corticosteroid | Active comparator | The non-combination topical corticosteroid will be applied to specific and marked sites on the forearms (on the flexor side of the forearm- 5*5 cm with a distance of 3 cm) - two sites on both forearms of every subject (4 sites in total). The nature of this application method will enable the measurement of the level of potency of each drug, in a manner that is comparative, neutralizing thus the influence of inter-subject variability.
The drugs will be topically applied (50 microliter on each site) for 16 hours, utilizing an occlusive dressing bandage such as Tegaderm. The vasoconstriction test will be preformed both before and after drug application. The vasoconstriction in each subject will be graded on the Olsen scale Receives: Combination Product: Combination topical corticosteroid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vasoconstriction Index (VI) measured by Skin Color Reflectometry
VI change following application topical corticosteroids that are incorporated with an antibiotic and/or antifungal drugs.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2018
- Study startNov 2018 (estimated)
- Primary completionMar 2019 (estimated)
- Study completionApr 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin ToxicityStudies 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 4
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ben-Gurion University of the Negev
- Sponsor type
- University, hospital or other
- Collaborators
- Soroka University Medical Center
- Responsible party
- Principal investigator, Alex Zvulunov, Ben-Gurion University of the Negev
- Investigators
- Raed Khoury, MD, Principal investigator, Soroka University Medical Center & Ben Gurion University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03606954
- Sponsor's protocol ID
- 0316-17-SOR
- Status last verified
- Jul 2018
- First submitted
- 21 Jul 2018
- Last updated
- 31 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Topical Corticosteroids Potency in Combination Preparations in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT03606954
- Acronym / sponsor ID
- 0316-17-SOR
- Conditions
- Skin Toxicity
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Ben-Gurion University of the NegevUniversity, hospital or other
- Collaborators
- Soroka University Medical Center
- Study start
- Nov 2018 (estimated)
- Primary completion
- Mar 2019 (estimated)
- Study completion
- Apr 2019 (estimated)
- First posted
- 31 Jul 2018 (actual)
- 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.
Several combination topical drugs are available on the market. The potency of corticosteroids depends on a particular molecular structure and the skin penetration properties. Besides molecular structure, a penetration of a corticosteroid molecule correlates with physical properties of the vehicle which depend on physical properties of the vehicle constituents.
Vasoconstriction assay is considered as the gold standard for testing potency of topical corticosteroids.
Detailed description
Primary outcome: Change in Vasoconstriction index following application of topical corticosteroids that are incorporated with or without an antibiotic and/or antifungal drugs in healthy volunteers.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Combination topical corticosteroid | Active comparator | Combination Product: Combination topical corticosteroidThe combination topical corticosteroid will be applied to specific and marked sites on the forearms (on the flexor side of the forearm- 5*5 cm with a distance of 3 cm) - two sites on both forearms of every subject (4 sites in total). The nature of this application method will enable the measurement of the level of potency of each drug, in a manner that is comparative, neutralizing thus the influence of inter-subject variability. The drugs will be topically applied (50 microliter on each site) for 16 hours, utilizing an occlusive dressing bandage such as Tegaderm. The vasoconstriction test will be preformed both before and after drug application. The vasoconstriction in each subject will be graded on the Olsen scale |
| Non-combination topical corticosteroid | Active comparator | Combination Product: Combination topical corticosteroidThe non-combination topical corticosteroid will be applied to specific and marked sites on the forearms (on the flexor side of the forearm- 5*5 cm with a distance of 3 cm) - two sites on both forearms of every subject (4 sites in total). The nature of this application method will enable the measurement of the level of potency of each drug, in a manner that is comparative, neutralizing thus the influence of inter-subject variability. The drugs will be topically applied (50 microliter on each site) for 16 hours, utilizing an occlusive dressing bandage such as Tegaderm. The vasoconstriction test will be preformed both before and after drug application. The vasoconstriction in each subject will be graded on the Olsen scale |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- No prior history of internal diseases that required vaccine-suppressing treatments
- Absence of an active skin disease.
Key exclusion criteria (3 listed)
- Treatment with topical corticosteroids in the 4 weeks prior to the study
- Immune-suppressive treatment in the 4 weeks prior to the study
- Pregnancy or breast feeding
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 |
|---|---|---|
| Combination topical corticosteroidComparison of a vasoconstriction index between the 2 study arms | Combination product | Combination topical corticosteroid, Non-combination topical corticosteroid |
Primary outcome
Vasoconstriction Index (VI) measured by Skin Color Reflectometry
Time frame: 24 hours
VI change following application topical corticosteroids that are incorporated with an antibiotic and/or antifungal drugs.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2018.
- Individual participant dataSharing planned: Undecided
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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.
Alex Zvulunov, MD contact
Raed Khoury, MD principal investigator
Soroka University Medical Center & Ben Gurion University
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Combination topical corticosteroid in people with Skin Toxicity, run by Ben-Gurion University of the Negev.
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 2 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 31 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Raed Khoury, MD (0507905159, raedkhoury1@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vasoconstriction Index (VI) measured by Skin Color Reflectometry (time frame: 24 hours). 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 31 Jul 2018.