An interventional study of Light Therapy Mask Cream in Allergic Sensitization, sponsored by Johnson & Johnson Consumer Products Company Division of Johnson & Johnson Consumer Companies, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-05-15.
Sponsored by Johnson & Johnson Consumer Products Company Division of Johnson & Johnson Consumer Companies, Inc. (formerly part of Johnson & Johnson) · Not applicable, Interventional, and Other
Patch Testing for device cream on human subjects
Johnson & Johnson Consumer Products Company Division of Johnson & Johnson Consumer Companies, Inc. is the lead sponsor of 5 studies on the registry; none are open to participants now.
First submitted before Johnson & Johnson Consumer Products Company Division of Johnson & Johnson Consumer Companies, Inc. left Johnson & Johnson.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Light Therapy Mask Cream
Device: Light Therapy Mask Cream
test panel
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 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
Time frame: approximately 6 weeks
| Milestone | Test Panel |
|---|---|
| Started | 118 |
| Completed | 110 |
| Not completed | 8 |
| Withdrew: Withdrawal by subject | 8 |
"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
| Participants | Test Panel |
|---|---|
| Number of Participants That Did Not Have Test Material Induced Clinically Significant Dermal Irritation | 110 |
Collected over 6 weeks. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Test Panel | 0/118 (0%) | 0/118 (0%) | 0/118 (0%) |
Only subjects that completed the study per protocol were included in the analysis
| Age, Categorical(Participants) | Test Panel |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 105 |
| >=65 years | 5 |
| Sex: Female, Male(Participants) | Test Panel |
|---|---|
| Female | 83 |
| Male | 27 |
| Race and Ethnicity Not Collected(Participants) | Test Panel |
|---|
Ran from Nov 2017 to primary completion in Dec 2017, 1 month.
Results were first posted in Apr 2019, 1 year 3 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2019. You cannot join it, but the record below documents what was studied.
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