Test the Phototoxicity of Sunscreen Products

Sponsor

Bayer (Industry)

Overall Status

Completed

CT.gov ID

NCT02802930

Collaborator

(none)

Enrollment

Location

Arm

Actual Duration (Days)

162.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The primary objective of this study was to evaluate the potential for phototoxicity of the sun care products SPF 50 Y65 110, SPF 50 Y51 002, and SPF 15 V27 104 compared to that of a negative control (0.9% sodium chloride [NaCl]) after a single 24 h application of test materials followed by irradiation with ultraviolet A (UVA) and ultraviolet B (UVB).

The secondary objective of this study was to evaluate the safety of the sun care products SPF 50 Y65 110, SPF 50 Y51 002, and SPF 15 V27 104 combined with UVA/B irradiation by monitoring adverse events (AEs) throughout the study.

Condition or Disease	Intervention/Treatment	Phase
Sunscreen Agents	Drug: SPF 50 Y65 110 (BAY987519) Drug: SPF 50 Y51 002 (BAY987519) Drug: SPF 15 V27 104 (BAY987519) Drug: Sodium chloride [NaCl]	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

32 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

Single (Participant)

Primary Purpose:

Other

Official Title:

A Randomized Study to Assess the Potential for Phototoxicity of SPF 50 Y65 110, SPF 50 Y51 002 and SPF 15 V27-104 in Human Subjects

Actual Study Start Date :

Apr 20, 2015

Actual Primary Completion Date :

Apr 26, 2015

Actual Study Completion Date :

Apr 26, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: SPF 50 Y65 110, SPF 50 Y51 002, and SPF 15 V27 104 All test products (SPF 50 Y65 110,SPF 50 Y51 002, and SPF 15 V27 l 04 compared to that of a negative control [0.9% NaCl]) were tested simultaneously on each subject.	Drug: SPF 50 Y65 110 (BAY987519) Application of 200 µL in an occlusive patch of Webril (0.150 ± 0.010 mg) compared to that of a negative control (0.9% sodium chloride, NaCl) and followed by irradiation with UV A and UVB. Drug: SPF 50 Y51 002 (BAY987519) Application of 200 µL in an occlusive patch of Webril compared to that of a negative control (0.9% sodium chloride, NaCl) and followed by irradiation with UV A and UVB. Drug: SPF 15 V27 104 (BAY987519) Application of 200 µL in an occlusive patch of Webril compared to that of a negative control (0.9% sodium chloride, NaCl) and followed by irradiation with UV A and UVB. Drug: Sodium chloride [NaCl] Negative control (200 µL, 0.9% sodium chloride [NaCl]) after a single 24 h application of test materials followed by irradiation with ultraviolet A (UVA) and ultraviolet B (UVB).

Arm

Intervention/Treatment

Experimental: SPF 50 Y65 110, SPF 50 Y51 002, and SPF 15 V27 104

All test products (SPF 50 Y65 110,SPF 50 Y51 002, and SPF 15 V27 l 04 compared to that of a negative control [0.9% NaCl]) were tested simultaneously on each subject.

Drug: SPF 50 Y65 110 (BAY987519)

Application of 200 µL in an occlusive patch of Webril (0.150 ± 0.010 mg) compared to that of a negative control (0.9% sodium chloride, NaCl) and followed by irradiation with UV A and UVB.

Drug: SPF 50 Y51 002 (BAY987519)

Application of 200 µL in an occlusive patch of Webril compared to that of a negative control (0.9% sodium chloride, NaCl) and followed by irradiation with UV A and UVB.

Drug: SPF 15 V27 104 (BAY987519)

Application of 200 µL in an occlusive patch of Webril compared to that of a negative control (0.9% sodium chloride, NaCl) and followed by irradiation with UV A and UVB.

Drug: Sodium chloride [NaCl]

Negative control (200 µL, 0.9% sodium chloride [NaCl]) after a single 24 h application of test materials followed by irradiation with ultraviolet A (UVA) and ultraviolet B (UVB).

Outcome Measures

Primary Outcome Measures

Skin irritation [up to 1 week]
Skin irritation was rated on a scale from 0-7 where 0 is no evidence of irritation and 7 is strong reaction spreading beyond test site

Secondary Outcome Measures

Number of adverse event as a measure of safety and tolerability [up to 1 week]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Male or female subjects, aged 18 to 65 years
Good general health, as assessed by medical history and brief visual examination of the skin
Fitzpatrick skin Type I IV, determined by interview at screening
Willing and able to practice an acceptable measure of contraception during the study, if female of childbearing potential
Willing to follow study rules, which include: no sun exposure; avoidance of activities that would cause excessive sweating; and no use of lotions, creams, or oils on the back area
Must be willing not to change current brand of personal care products such as soaps, body washes, laundry detergent, body sprays, and body spritzes while participating in the study

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Pinellas Park	Florida	United States	33781

Sponsors and Collaborators

Bayer

Investigators

Study Director: Bayer Study Director, Bayer

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Bayer

ClinicalTrials.gov Identifier:

NCT02802930

Other Study ID Numbers:

18287

First Posted:

Jun 16, 2016

Last Update Posted:

Dec 12, 2018

Last Verified:

Dec 1, 2018

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Dermatitis, Phototoxic

Study Results

No Results Posted as of Dec 12, 2018