Sunscreening Agents Clinical Trial
Official title:
Sun Protection Factor (SPF) Assay: UVA Protection Factor Assay Minimal Persistent Pigment-Darkening Dose
NCT number | NCT02930772 |
Other study ID # | 19201 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | October 12, 2016 |
Est. completion date | November 3, 2016 |
Verified date | December 2018 |
Source | Bayer |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
To evaluate the Sun Protection Factor efficacy on human skin.
Status | Completed |
Enrollment | 11 |
Est. completion date | November 3, 2016 |
Est. primary completion date | November 3, 2016 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility |
Inclusion Criteria: - Fitzpatrick Skin Type l, ll and/or lll for UVB testing. Fitzpatrick Skin Type ll, lll and/or lV for UVA testing. - Male and female. - Aged between 18-70 years old. - Good health as determined from the HRL SHF (Subject History Form). - Signed and dated Informed Consent Form. - Signed and dated HIPAA (Health Insurance Portability and Accountability Act) form. - An unambiguous MED (Minimal Erythema Dose) or MPPD (Minimal Persistent Pigment Darkening Dose). Exclusion Criteria: - Subjects on test at any other research laboratory or clinic. - Known allergy or sensitivity to sunscreens, cosmetics and toiletries, topical drugs and/or ultraviolet light. - Pre-existing dermatologic conditions which have been diagnoses by a medical professional (e.g. psoriasis, eczema, etc.) which would interfere with this study. - Pre-existing other medical conditions (e.g. adult asthma, diabetes). - Treatment with antihistamines or corticosteroids within one week prior to initiation of the test. - Treatment with antibiotics within two weeks prior to initiation of the test. - Chronic medication which could affect the results of the study. - Known pregnant or nursing women. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Bayer |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Minimal Erythema Dose (MED) | Up to 15 minutes | ||
Primary | Minimal Persistent Pigment Darkening Dose (MPPD) | Up to 15 minutes |
Status | Clinical Trial | Phase | |
---|---|---|---|
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