check_circleStudy Completed

Photoallergy

Bayer Identifier:

18291

ClinicalTrials.gov Identifier:

NCT02872220

EudraCT Number:

Not Available

EU CT Number:

Not Available
To test for photo allergy reaction of sunscreens

Trial purpose

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.

Key Participants Requirements

Sex

Both

Age

18 - 65 Years
  • - 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

Trial summary

Enrollment Goal
56
Trial Dates
March 2015 - May 2015
Phase
N/A
Could I Receive a placebo
No
Products
BAY987519
Accepts Healthy Volunteer
Yes

Where to participate

StatusInstitutionLocation
Completed
Pinellas Park, 33781, United States

Primary Outcome

  • 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)
    date_rangeTime Frame:
    up to 3 weeks
    enhanced_encryption
    Safety Issue:
    Yes
  • 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
    date_rangeTime Frame:
    up to 3 weeks
    enhanced_encryption
    Safety Issue:
    Yes

Secondary Outcome

  • Adverse event collection as a measure of safety and tolerability
    date_rangeTime Frame:
    up to 3 weeks
    enhanced_encryption
    Safety Issue:
    Yes

Trial design

A randomized study to assess the potential for photoallergy of SPF 50 Y65 110, SPF 50 Y51 002 and SPF 15 V27 104 in human subjects
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Other
Allocation
N/A
Blinding
Single Blind
Assignment
Single Group Assignment
Trial Arms
1

Additional Information

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