ErythemaHRIPTNCT04498676
50 Human Subject Repeat Insult Patch Test
A study testing CB-0002B in people with Erythema and Sensitisation, run by CAGE Bio Inc. at 1 site in United States.
Trial summary
Consumer products or raw materials designed for consistent reapplication to areas of the skin may, under proper conditions, prove to be contact sensitizers or irritants in certain individuals. Read more about this study
- Who is it for?
- Ages 21 to 67 yearsHealthy volunteers can take part
- Conditions the study is for
- Erythema, Sensitisation
- What is being tested?
- CB-0002B
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Jan 2017to 2 Mar 2017
- Phase
- Interventional
- 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 21 to 67 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Individuals who are not currently under a doctor's care
- Individuals free of any dermatological or systemic disorder which would interfere with the results, at the discretion of the Investigator.
- Individuals free of any acute or chronic disease that might interfere with or increase the risk of study participation.
- Individuals who will complete a preliminary medical history form mandated by AMA Laboratories, Inc. and are in general good health.
- Individuals, who will read, understand and sign an informed consent document relating to the specific type of study they are subscribing. Consent forms are kept on file and are available for examination on the premises of AMA Laboratories, Inc. only.
- Individuals able to cooperate with the Investigator and research staff, willing to have test materials applied according to the protocol, and complete the full course of the study.
Who cannot join
- Individuals under 18 years of age.
- Individuals who are currently under a doctor's care.
- Individuals who are currently taking any medication (topical or systemic) that may mask or interfere with the test results.
- Subjects with a history of any acute or chronic disease that might interfere with or increase the risk associated with study participation.
- Individuals diagnosed with chronic skin allergies.
- Female volunteers who indicate that they are pregnant or lactating.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 50 Human Subject Repeat Insult Patch Test Skin Irritation/Sensitization Evaluation (Occlusive Patch)
Consumer products or raw materials designed for consistent reapplication to areas of the skin may, under proper conditions, prove to be contact sensitizers or irritants in certain individuals. It is the intention of a Repeat Insult Patch Test (RIPT) to provide a basis for evaluation of this irritation/sensitization potential if such exists.
- Conditions
- Erythema, Sensitisation
- Being tested
- CB-0002B
- Keywords
- HRIPT, irritant
- Medical subject headings
- Erythema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CB-0002BOther
CB-0002B (choline geranate) is a viscous transparent colorless to light yellow liquid
| Study group | Role | What they receive |
|---|---|---|
| Test product | Experimental | Not described Receives: Other: CB-0002B |
What is being measured
The primary outcome is the main question the study is designed to answer.
Erythema
Erythema rated on a numeric scale from 0 - 4. (0: None; 1: Minimal; 2: Mild; 3: Marked and 4: Severe erythema)
Measured: 21 days
Sensitisation
After a 10-14 day rest period, a challenge test was given at a different skin site to look for signals of a sensitization response measured by rating erythema on a scale from 0 - 4
Measured: 24 hours
Sensitisation
After a 10-14 day rest period, a challenge test was given at a different skin site to look for signals of a sensitization response measured by rating erythema on a scale from 0 - 4
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2020
- Study start18 Jan 2017
- Primary completion8 Feb 2017
- Study completion2 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ErythemaStudies 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 N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- CAGE Bio Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- AMA Laboratories, Inc.
- Responsible party
- Sponsor
- Investigators
- Director, Study director, AMA Laboratories, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04498676
- Sponsor's protocol ID
- MS17.RIPT.P1200O.50.CBIO
- Acronym
- HRIPT
- Status last verified
- Jul 2020
- First submitted
- 29 Jul 2020
- Last updated
- 4 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- 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 4 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 50 Human Subject Repeat Insult Patch Test Skin Irritation/Sensitization Evaluation (Occlusive Patch)
- ClinicalTrials.gov ID
- NCT04498676
- Acronym / sponsor ID
- HRIPT / MS17.RIPT.P1200O.50.CBIO
- Conditions
- Erythema, Sensitisation
- Keywords
- HRIPT, irritant
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- CAGE Bio Inc.Industry (pharma, biotech, devices)
- Collaborators
- AMA Laboratories, Inc.
- Study start
- 18 Jan 2017 (actual)
- Primary completion
- 8 Feb 2017 (actual)
- Study completion
- 2 Mar 2017 (actual)
- First posted
- 4 Aug 2020 (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.
Consumer products or raw materials designed for consistent reapplication to areas of the skin may, under proper conditions, prove to be contact sensitizers or irritants in certain individuals. It is the intention of a Repeat Insult Patch Test (RIPT) to provide a basis for evaluation of this irritation/sensitization potential if such exists.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Test product | Experimental | Other: CB-0002B |
Who may qualify
- Ages
- 21 to 67 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Individuals who are not currently under a doctor's care
- Individuals free of any dermatological or systemic disorder which would interfere with the results, at the discretion of the Investigator.
- Individuals free of any acute or chronic disease that might interfere with or increase the risk of study participation.
- Individuals who will complete a preliminary medical history form mandated by AMA Laboratories, Inc. and are in general good health.
- Individuals, who will read, understand and sign an informed consent document relating to the specific type of study they are subscribing. Consent forms are kept on file and are available for examination on the premises of AMA Laboratories, Inc. only.
Key exclusion criteria (6 listed)
- Individuals under 18 years of age.
- Individuals who are currently under a doctor's care.
- Individuals who are currently taking any medication (topical or systemic) that may mask or interfere with the test results.
- Subjects with a history of any acute or chronic disease that might interfere with or increase the risk associated with study participation.
- Individuals diagnosed with chronic skin allergies.
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 |
|---|---|---|
| CB-0002BCB-0002B (choline geranate) is a viscous transparent colorless to light yellow liquid | Other | Test product |
Primary outcome
Erythema
Time frame: 21 days
Erythema rated on a numeric scale from 0 - 4. (0: None; 1: Minimal; 2: Mild; 3: Marked and 4: Severe erythema)
Sensitisation
Time frame: 24 hours
After a 10-14 day rest period, a challenge test was given at a different skin site to look for signals of a sensitization response measured by rating erythema on a scale from 0 - 4
Sensitisation
Time frame: 48 hours
After a 10-14 day rest period, a challenge test was given at a different skin site to look for signals of a sensitization response measured by rating erythema on a scale from 0 - 4
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 4 Aug 2020.
- Individual participant dataSharing planned: No
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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.
Director study director
AMA Laboratories, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CB-0002B in people with Erythema and Sensitisation, run by CAGE Bio Inc. at 1 site in United States.
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 6 inclusion and 6 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 4 Aug 2020. 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 United States. 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.
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?
Erythema (time frame: 21 days). The study lists 3 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 4 Aug 2020.