Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02760563
Other study ID # 18611
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 19, 2015
Est. completion date October 22, 2015

Study information

Verified date December 2018
Source Bayer
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To evaluate the Sun Protection Factor efficacy on human skin.


Recruitment information / eligibility

Status Completed
Enrollment 10
Est. completion date October 22, 2015
Est. primary completion date October 22, 2015
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 Form (Health Insurance Portability and Accountability Act).

- 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 diagnosed 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
BAY 987517
Each 50 cm*2 test site area of a subject requires 100 mg of a test material to obtain a standard 2 mg/cm*2 test application (Formulation number V26-160)

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Bayer

Country where clinical trial is conducted

United States, 

Outcome

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
See also
  Status Clinical Trial Phase
Completed NCT02779270 - Test the Outdoor Usage for Sunscreen Products in Female Adults N/A
Completed NCT02936583 - Sun Protection Factor Assay (SPF Assay 207/2016) N/A
Completed NCT02936544 - Sun Protection Factor Assay (SPF Assay 204/2016) N/A
Completed NCT02936570 - Sun Protection Factor Assay (SPF Assay 206/2016) N/A
Completed NCT02936557 - Sun Protection Factor Assay (SPF Assay 205/2016) N/A
Completed NCT05085327 - Clinical Study to Evaluate the Sun Protection Factor (SPF) of Sunscreen Products N/A
Completed NCT02930798 - Sun Protection Factor Assay (SPF Assay 203/2016) N/A
Completed NCT02854137 - Evaluation of the Irritation Potential of Sunscreen Products in Human Eyes N/A
Completed NCT02760576 - 18612 - Sun Protection Factor Assay N/A
Completed NCT02930759 - Sun Protection Factor Assay (SPF Assay 200/2016) N/A
Completed NCT02930772 - Sun Protection Factor Assay (SPF Assay 201/2016) N/A
Completed NCT02930785 - Sun Protection Factor Assay (SPF Assay 202/2016) N/A
Completed NCT02930746 - Sun Protection Factor Assay (SPF Assay 199/2016) N/A
Completed NCT05109104 - Clinical Study to Evaluate the Sun Protection Factor (SPF) of Three Sunscreen Products N/A
Completed NCT04355286 - Bemotrizinol UV Filter Part 1 Clinical PK Evaluation in Topical MUsT Study Phase 1
Completed NCT02962869 - Human Photoallergy Test (824/2016) N/A
Completed NCT02823483 - 18348-Human Phototoxicity Test N/A
Completed NCT02823496 - 18349-Human Photoallergy Test N/A
Completed NCT02962856 - Human Phototoxicity Test (823/2016) N/A
Completed NCT05124899 - Clinical Study to Evaluate the 80-Minute Water Resistant Sun Protection Factor (SPF) of Sunscreen Products N/A