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. · Not applicable, Interventional, and Other
Patch Testing for device cream on human subjects
Exclusion Criteria:
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 |
|---|
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Johnson & Johnson Consumer Products Company Division of Johnson & Johnson Consumer Companies, Inc.