Allergic SensitizationRIPTNCT03450070
Repeat Insult Patch Test APPENDIX I to HRL Standard Protocol #100
A study testing Light Therapy Mask Cream in people with Allergic Sensitization, run by Johnson & Johnson Consumer Products Company Division of Johnson & Johnson Consumer Companies, Inc. at 1 site in United States.
Trial summary
Patch Testing for device cream on human subjects Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Allergic Sensitization
- What is being tested?
- Light Therapy Mask Cream
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 121 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Nov 2017to 22 Dec 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or Female
- 18+ years
- Good health
- Signed and datad Informed Consent
- Signed and dated HIPAA
Who cannot join
- On test at any other research lab or clinic
- Known allergy or sensitivity to cosmetics or toiletries
- Pre-existing other medical conditions
- Treatment with antibiotics, antihistamines, or corticosteroids within 2 weeks of the test
- Chronic medication which could affect the outcome of the study
- Known pregnant or nursing women
- Cancer diagnosis within the past 5 years
Trial locations and contacts
1 site in 1 country.
United States1 site
Harrison Research Laboratories
Union, New Jersey, 07083
About this study
Official title: Repeat Insult Patch Testing (RIPT) APPENDIX I to HRL Standard Protocol #100
Patch Testing for device cream on human subjects
- Conditions
- Allergic Sensitization
- Being tested
- Light Therapy Mask Cream
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Light Therapy Mask CreamDevice
test panel
| Study group | Role | What they receive |
|---|---|---|
| Test Panel | Experimental | Light Therapy Mask Cream Receives: Device: Light Therapy Mask Cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants That Did Not Have Test Material Induced Clinically Significant Dermal Irritation
"Clinically Significant Dermal Irritation" refers to an overall outcome measure in which, after 6 weeks of the test (patching the skin (3 weeks) \& then challenging the skin (at week 6)), the test product caused a clinically significant dermal reaction (scores of 2 or greater). Participant scores less than 2 are not considered to be Clinically significant.
Scoring System:
0 = No visible reaction
± = Faint, minimal erythema
- = Erythema
- = Intense erythema
- = Intense erythema, induration, vesicles
- = Severe reaction with erythema, induration, vesicles, pustules (may be weeping) E = Edema DR = Dryness P = Peeling S = Staining
- = Hyperpigmentation / Hypopigmentation C = Change of test site N9R = No 9th reading
- = No patch application and / or reading TR = Tape Reaction
Measured: approximately 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2018
- Study start15 Nov 2017
- Primary completion22 Dec 2017
- Study completion22 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Allergic SensitizationStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 121 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Consumer Products Company Division of Johnson & Johnson Consumer Companies, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03450070
- Sponsor's protocol ID
- CO- 171028001439-SACT
- Acronym
- RIPT
- Status last verified
- May 2019
- First submitted
- 19 Jan 2018
- Last updated
- 15 May 2019
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Repeat Insult Patch Testing (RIPT) APPENDIX I to HRL Standard Protocol #100
- ClinicalTrials.gov ID
- NCT03450070
- Acronym / sponsor ID
- RIPT / CO- 171028001439-SACT
- Conditions
- Allergic Sensitization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 121 participants (actual)
- Lead sponsor
- Johnson & Johnson Consumer Products Company Division of Johnson & Johnson Consumer Companies, Inc.Industry (pharma, biotech, devices)
- Study start
- 15 Nov 2017 (actual)
- Primary completion
- 22 Dec 2017 (actual)
- Study completion
- 22 Dec 2017 (actual)
- First posted
- 1 Mar 2018 (actual)
- Results
- Posted 3 Apr 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patch Testing for device cream on human subjects
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Test Panel | Experimental | Device: Light Therapy Mask CreamLight Therapy Mask Cream |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or Female
- 18+ years
- Good health
- Signed and datad Informed Consent
- Signed and dated HIPAA
Key exclusion criteria (7 listed)
- On test at any other research lab or clinic
- Known allergy or sensitivity to cosmetics or toiletries
- Pre-existing other medical conditions
- Treatment with antibiotics, antihistamines, or corticosteroids within 2 weeks of the test
- Chronic medication which could affect the outcome of the study
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 |
|---|---|---|
| Light Therapy Mask Creamtest panel | Device | Test Panel |
Primary outcome
Number of Participants That Did Not Have Test Material Induced Clinically Significant Dermal Irritation
Time frame: approximately 6 weeks
"Clinically Significant Dermal Irritation" refers to an overall outcome measure in which, after 6 weeks of the test (patching the skin (3 weeks) \& then challenging the skin (at week 6)), the test product caused a clinically significant dermal reaction (scores of 2 or greater). Participant scores less than 2 are not considered to be Clinically significant. Scoring System: 0 = No visible reaction ± = Faint, minimal erythema 1. = Erythema 2. = Intense erythema 3. = Intense erythema, induration, vesicles 4. = Severe reaction with erythema, induration, vesicles, pustules (may be weeping) E = Edema DR = Dryness P = Peeling S = Staining * = Hyperpigmentation / Hypopigmentation C = Change of test site N9R = No 9th reading * = No patch application and / or reading TR = Tape Reaction
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Allergic Sensitization
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Mild or Moderate Asthma With Allergic Sensitization
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 study testing Light Therapy Mask Cream in people with Allergic Sensitization, run by Johnson & Johnson Consumer Products Company Division of Johnson & Johnson Consumer Companies, 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 5 inclusion and 7 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 15 May 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 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?
Yes. Results are posted in the registry (first posted 3 Apr 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants That Did Not Have Test Material Induced Clinically Significant Dermal Irritation (time frame: approximately 6 weeks). 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 15 May 2019; AzTrials last refreshed its copy on 28 Oct 2026.