NCT02872220

Brief Summary

The primary objective of this tudy was to evaluate the potential of photoallergy of of sun care products Sun Protection Factor (SPF) 50 Y65 110, SPF 50 Y51 002, and SPF 15 V27 104 application compared to that of a negative control (0.9% sodium chloride, NaCl) and followed by irradiation with UV A and UVB. The secondary objective aims for evaluation of the safety of SPF 50 Y65 110, SPF 50 Y51 002, and SPF 15 V27 104 combined with ultraviolet (UV) A/B irradiation by monitoring adverse events (AEs) throughout the study.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 23, 2015

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 8, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 8, 2015

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

June 14, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 19, 2016

Completed
Last Updated

December 12, 2018

Status Verified

December 1, 2018

Enrollment Period

2 months

First QC Date

June 14, 2016

Last Update Submit

December 11, 2018

Conditions

Photoallergy

Outcome Measures

Primary Outcomes (2)

  • Evaluation of inflammatory responses

    Inflammatory responses (Based on scores): 0 = No visible reaction + = Slight, confluent, or patchy erythema 1 = Mild erythema (pink) 2 = Moderate erythema (definite redness) 3 = Strong erythema (very intense redness)

    up to 3 weeks

  • Evaluation of superficial effects

    Superficial effects: g = Glazing y = Peeling c = Scab, dried film of serous exudate of vesicular or bulla reaction d = Hyperpigmentation (reddish brown discoloration of test site) h = Hypopigmentation (loss of visible pigmentation at test site) f = Fissuring grooves in the superficial layers of the skin

    up to 3 weeks

Secondary Outcomes (1)

  • Adverse event collection as a measure of safety and tolerability

    up to 3 weeks

Study Arms (1)

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

EXPERIMENTAL

All test products compared to that of a negative control \[0.9% NaCl\] were tested simultaneously on each subject.

Drug: SPF 50 Y65 110 (BAY987519)Drug: SPF 50 Y51 002 (BAY987519)Drug: SPF 15 V27 104 (BAY987519)Drug: Sodium chloride [NaCl]

Interventions

SPF 50 Y65 110 (BAY987519)DRUG

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.

SPF 50 Y65 110, SPF 50 Y51 002, and SPF 15 V27 104
SPF 50 Y51 002 (BAY987519)DRUG

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.

SPF 50 Y65 110, SPF 50 Y51 002, and SPF 15 V27 104
SPF 15 V27 104 (BAY987519)DRUG

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.

SPF 50 Y65 110, SPF 50 Y51 002, and SPF 15 V27 104
Sodium chloride [NaCl]DRUG

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).

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

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Men or women, aged 18 to 65 with good general health
  • Fitzpatrick skin type I IV
  • Females (of childbearing potential) on acceptable measure of contraception
  • Willing to follow study rules, which include: no sun exposure (for example, no swimming, sunbathing, or tanning beds), avoidance of activities that would cause excessive sweating, no use of lotions, creams, or oils on the back area
  • Willing to not change the current brand of personal care products such as soaps, body washes, laundry detergent, body sprays, body spritzes, etc. while participating in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Pinellas Park, Florida, 33781, United States

Location

MeSH Terms

Conditions

Dermatitis, Photoallergic

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Dermatitis, Allergic ContactDermatitis, ContactDermatitisSkin DiseasesSkin and Connective Tissue DiseasesPhotosensitivity DisordersSkin Diseases, EczematousHypersensitivity, DelayedHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

ChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 14, 2016

First Posted

August 19, 2016

Study Start

March 23, 2015

Primary Completion

May 8, 2015

Study Completion

May 8, 2015

Last Updated

December 12, 2018

Record last verified: 2018-12

Locations

US(1)