Skin Irritation
Conditions
Keywords
Cetaphil Daily Facial Moisturizer with SPF 50+, Hypoallergenicity, Skin Irritation
Brief summary
This study examined the possible sensitization and irritation effects of a moisturizer with sunscreen SPF 50+.
Detailed description
The design for this study is standard for human repeat insult patch tests. To test the moisturizer with sunscreen SPF 50+ for the potential to induce contact sensitization by repetitive applications, healthy subjects received 9 applications at 48 to 72 hour intervals of the moisturizer to the upper back. Patches were remained on the skin for approximately 48 to 72 hours. Twelve to 24 days after the previous applications, subjects were patched with the moisturizer at the original site and an alternative site for 48 hours.
Interventions
DRUGFacial Moisturizer with SPF 50+
All subjects received applications of occlusive patches dosed with Cetaphil Daily Facial Moisturizer with SPF 50+
Sponsors
Galderma R&D
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* Men or women 18 to 70 years of age in general good health * Can read, understand, and sign informed consent
Exclusion criteria
* History of acute or chronic disease * Diagnosed with chronic skin allergies * Pregnant or lactating
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Area of Erythema and Elevated Responses of Skin to Product | 3 consecutive weeks | 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. |
Countries
United States
Participant flow
Recruitment details
Subjects were screened at a single US center.
Participants by arm
| Arm | Count |
|---|---|
| Facial Moisturizer With SPF 50+ All subjects received Cetaphil Daily Facial Moisturizer with SPF 50+ | 110 |
| Total | 110 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Protocol Violation | 12 |
| Overall Study | Withdrawal by Subject | 6 |
Baseline characteristics
| Characteristic | Facial Moisturizer With SPF 50+ |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 1 Participants |
| Age, Categorical Between 18 and 65 years | 109 Participants |
| Age, Continuous | 44.0 years STANDARD_DEVIATION 13.68 |
| Race/Ethnicity, Customized African American | 10 Participants |
| Race/Ethnicity, Customized Asian | 3 Participants |
| Race/Ethnicity, Customized Caucasian | 71 Participants |
| Race/Ethnicity, Customized Caucasian/Hispanic | 3 Participants |
| Race/Ethnicity, Customized Hispanic | 23 Participants |
| Region of Enrollment United States | 110 participants |
| Sex: Female, Male Female | 86 Participants |
| Sex: Female, Male Male | 24 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 110 |
| serious Total, serious adverse events | 0 / 110 |
Outcome results
Primary
Area of Erythema and Elevated Responses of Skin to Product
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.
Time frame: 3 consecutive weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Patch 1 | Area of Erythema and Elevated Responses of Skin to Product | Moderate | 0 participants |
| Patch 1 | Area of Erythema and Elevated Responses of Skin to Product | None | 91 participants |
| Patch 1 | Area of Erythema and Elevated Responses of Skin to Product | Mild | 19 participants |
| Patch 2 | Area of Erythema and Elevated Responses of Skin to Product | Moderate | 1 participants |
| Patch 2 | Area of Erythema and Elevated Responses of Skin to Product | Mild | 41 participants |
| Patch 2 | Area of Erythema and Elevated Responses of Skin to Product | None | 68 participants |
| Patch 3 | Area of Erythema and Elevated Responses of Skin to Product | Mild | 72 participants |
| Patch 3 | Area of Erythema and Elevated Responses of Skin to Product | None | 33 participants |
| Patch 3 | Area of Erythema and Elevated Responses of Skin to Product | Moderate | 5 participants |
| Patch 4 | Area of Erythema and Elevated Responses of Skin to Product | None | 42 participants |
| Patch 4 | Area of Erythema and Elevated Responses of Skin to Product | Moderate | 0 participants |
| Patch 4 | Area of Erythema and Elevated Responses of Skin to Product | Mild | 68 participants |
| Patch 5 | Area of Erythema and Elevated Responses of Skin to Product | Mild | 69 participants |
| Patch 5 | Area of Erythema and Elevated Responses of Skin to Product | None | 39 participants |
| Patch 5 | Area of Erythema and Elevated Responses of Skin to Product | Moderate | 2 participants |
| Patch 6 | Area of Erythema and Elevated Responses of Skin to Product | Moderate | 8 participants |
| Patch 6 | Area of Erythema and Elevated Responses of Skin to Product | None | 20 participants |
| Patch 6 | Area of Erythema and Elevated Responses of Skin to Product | Mild | 82 participants |
| Patch 7 | Area of Erythema and Elevated Responses of Skin to Product | Mild | 72 participants |
| Patch 7 | Area of Erythema and Elevated Responses of Skin to Product | None | 33 participants |
| Patch 7 | Area of Erythema and Elevated Responses of Skin to Product | Moderate | 5 participants |
| Patch 8 | Area of Erythema and Elevated Responses of Skin to Product | None | 33 participants |
| Patch 8 | Area of Erythema and Elevated Responses of Skin to Product | Mild | 72 participants |
| Patch 8 | Area of Erythema and Elevated Responses of Skin to Product | Moderate | 5 participants |
| Patch 9 | Area of Erythema and Elevated Responses of Skin to Product | None | 23 participants |
| Patch 9 | Area of Erythema and Elevated Responses of Skin to Product | Mild | 78 participants |
| Patch 9 | Area of Erythema and Elevated Responses of Skin to Product | Moderate | 9 participants |
| Challenge Patch (Original Site) - 48 Hours | Area of Erythema and Elevated Responses of Skin to Product | Mild | 31 participants |
| Challenge Patch (Original Site) - 48 Hours | Area of Erythema and Elevated Responses of Skin to Product | Moderate | 1 participants |
| Challenge Patch (Original Site) - 48 Hours | Area of Erythema and Elevated Responses of Skin to Product | None | 78 participants |
| Challenge Patch (Original Site) - 96 Hours | Area of Erythema and Elevated Responses of Skin to Product | Mild | 24 participants |
| Challenge Patch (Original Site) - 96 Hours | Area of Erythema and Elevated Responses of Skin to Product | None | 85 participants |
| Challenge Patch (Original Site) - 96 Hours | Area of Erythema and Elevated Responses of Skin to Product | Moderate | 1 participants |
| Challenge Patch (Alternate Site) - 48 Hours | Area of Erythema and Elevated Responses of Skin to Product | None | 86 participants |
| Challenge Patch (Alternate Site) - 48 Hours | Area of Erythema and Elevated Responses of Skin to Product | Moderate | 1 participants |
| Challenge Patch (Alternate Site) - 48 Hours | Area of Erythema and Elevated Responses of Skin to Product | Mild | 23 participants |
| Challenge Patch (Alternate Site) - 96 Hours | Area of Erythema and Elevated Responses of Skin to Product | Moderate | 3 participants |
| Challenge Patch (Alternate Site) - 96 Hours | Area of Erythema and Elevated Responses of Skin to Product | Mild | 12 participants |
| Challenge Patch (Alternate Site) - 96 Hours | Area of Erythema and Elevated Responses of Skin to Product | None | 95 participants |