Trial Outcomes & Findings for Repeat Insult Patch Test APPENDIX I to HRL Standard Protocol #100 (NCT NCT03450070)
NCT ID: NCT03450070
Last Updated: 2019-05-15
Results Overview
"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
COMPLETED
NA
121 participants
approximately 6 weeks
2019-05-15
Participant Flow
There were 121 subjects enrolled. 3 of those subjects were disconinued prior to being patched due to screen failure. Therefore, 118 subjects started using patches.
Participant milestones
| Measure |
Test Panel
Light Therapy Mask Cream
|
|---|---|
|
Overall Study
STARTED
|
118
|
|
Overall Study
COMPLETED
|
110
|
|
Overall Study
NOT COMPLETED
|
8
|
Reasons for withdrawal
| Measure |
Test Panel
Light Therapy Mask Cream
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
8
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Test Panel
n=110 Participants
Light Therapy Mask Cream
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=110 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
105 Participants
n=110 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=110 Participants
|
|
Sex: Female, Male
Female
|
83 Participants
n=110 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=110 Participants
|
PRIMARY outcome
Timeframe: 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
Outcome measures
| Measure |
Test Panel
n=110 Participants
Light Therapy Mask Cream
|
|---|---|
|
Number of Participants That Did Not Have Test Material Induced Clinically Significant Dermal Irritation
|
110 Participants
|
Adverse Events
Test Panel
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Principal Investigator (PI) will provide Sponsor with at least sixty (60) days to review any Publication. No Publication that incorporates Sponsor Confidential Information will be submitted for publication without Sponsor's prior written consent. If requested in writing, the PI withholds such Publication for up to an additional sixty (60) days to allow for filing of a patent application.
- Publication restrictions are in place
Restriction type: OTHER