Trial Outcomes & Findings for Cetaphil® Daily Facial Moisturizer With Sunscreen SPF 50+ - Human Repeat Insult Patch Test (NCT NCT01892657)

Last Updated: 2022-08-01

Results Overview

Subjects were patched 9 times at 48 hour to 72 hour intervals and graded for erythema and elevated responses (edema, papules, vesicles, bullae) on a 4 point scale (0 = none, 1 = mild, 2 = moderate, 3 = severe). 12 to 24 hours after the last patch application, a challenge patch was applied at the same site and a challenge patch was applied to an alternate site. Both were graded for the same criteria at 48 hours and at 96 hours. A total of 11 patches were applied to each subject. All patches were removed after 48 hours.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

128 participants

Primary outcome timeframe

3 consecutive weeks

Results posted on

2022-08-01

Participant Flow

Subjects were screened at a single US center.

Participant milestones

Participant milestones
Measure	Facial Moisturizer With SPF 50+ All subjects received Cetaphil Daily Facial Moisturizer with SPF 50+
Overall Study STARTED	128
Overall Study COMPLETED	110
Overall Study NOT COMPLETED	18

Reasons for withdrawal

Reasons for withdrawal
Measure	Facial Moisturizer With SPF 50+ All subjects received Cetaphil Daily Facial Moisturizer with SPF 50+
Overall Study Withdrawal by Subject	6
Overall Study Protocol Violation	12

Baseline Characteristics

Cetaphil® Daily Facial Moisturizer With Sunscreen SPF 50+ - Human Repeat Insult Patch Test

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Facial Moisturizer With SPF 50+ n=110 Participants All subjects received Cetaphil Daily Facial Moisturizer with SPF 50+
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	109 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Age, Continuous	44.0 years STANDARD_DEVIATION 13.68 • n=5 Participants
Sex: Female, Male Female	86 Participants n=5 Participants
Sex: Female, Male Male	24 Participants n=5 Participants
Race/Ethnicity, Customized African American	10 Participants n=5 Participants
Race/Ethnicity, Customized Asian	3 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	71 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic	23 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian/Hispanic	3 Participants n=5 Participants
Region of Enrollment United States	110 participants n=5 Participants

PRIMARY outcome

Timeframe: 3 consecutive weeks

Outcome measures

Outcome measures
Measure	Patch 1 n=110 Participants Subjects received a patch dosed with 100 microliters of Cetaphil Daily Facial Moisturizer with SPF 50+	Patch 2 n=110 Participants Subjects received a patch dosed with 100 microliters of Cetaphil Daily Facial Moisturizer with SPF 50+	Patch 3 n=110 Participants Subjects received a patch dosed with 100 microliters of Cetaphil Daily Facial Moisturizer with SPF 50+	Patch 4 n=110 Participants Subjects received a patch dosed with 100 microliters of Cetaphil Daily Facial Moisturizer with SPF 50+	Patch 5 n=110 Participants Subjects received a patch dosed with 100 microliters of Cetaphil Daily Facial Moisturizer with SPF 50+	Patch 6 n=110 Participants Subjects received a patch dosed with 100 microliters of Cetaphil Daily Facial Moisturizer with SPF 50+	Patch 7 n=110 Participants Subjects received a patch dosed with 100 microliters of Cetaphil Daily Facial Moisturizer with SPF 50+	Patch 8 n=110 Participants Subjects received a patch dosed with 100 microliters of Cetaphil Daily Facial Moisturizer with SPF 50+	Patch 9 n=110 Participants Subjects received a patch dosed with 100 microliters of Cetaphil Daily Facial Moisturizer with SPF 50+	Challenge Patch (Original Site) - 48 Hours n=110 Participants The challenge patch dosed with 100 microliters of Cetaphil Daily Facial Moisturizer with SPF 50+ applied to the original application site was graded at 48 hours.	Challenge Patch (Original Site) - 96 Hours n=110 Participants The challenge patch dosed with 100 microliters of Cetaphil Daily Facial Moisturizer with SPF 50+ applied to the original application site was graded again at 96 hours.	Challenge Patch (Alternate Site) - 48 Hours n=110 Participants A challenge patch dosed with 100 microliters of Cetaphil Daily Facial Moisturizer with SPF 50+ applied to an alternate application site was graded at 48 hours.	Challenge Patch (Alternate Site) - 96 Hours n=110 Participants A challenge patch dosed with 100 microliters of Cetaphil Daily Facial Moisturizer with SPF 50+ applied to an alternate application site was graded again at 96 hours.
Area of Erythema and Elevated Responses of Skin to Product None	91 participants	68 participants	33 participants	42 participants	39 participants	20 participants	33 participants	33 participants	23 participants	78 participants	85 participants	86 participants	95 participants
Area of Erythema and Elevated Responses of Skin to Product Mild	19 participants	41 participants	72 participants	68 participants	69 participants	82 participants	72 participants	72 participants	78 participants	31 participants	24 participants	23 participants	12 participants
Area of Erythema and Elevated Responses of Skin to Product Moderate	0 participants	1 participants	5 participants	0 participants	2 participants	8 participants	5 participants	5 participants	9 participants	1 participants	1 participants	1 participants	3 participants

Adverse Events

Facial Moisturizer With SPF 50+

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Elizabeth M. Nieman, Medical Information Specialist

Galderma Laboratories, L.P.

Phone: 817-961-5130

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60