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Completed

NCT Number: NCT02872220

To Test for Photo Allergy Reaction of Sunscreens

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.

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Key information

Conditions

Photoallergy Dermatitis Dermatitis, Allergic Contact Dermatitis, Contact Dermatitis, Photoallergic Hypersensitivity Hypersensitivity, Delayed Immune System Diseases Photosensitivity Disorders Skin Diseases Skin Diseases, Eczematous Skin and Connective Tissue Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pinellas Park, Florida, 33781, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Treatment and study plan

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 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 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.

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).

Primary outcomes

  1. Evaluation of inflammatory responses

    Time frame: up to 3 weeks

    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)

  2. Evaluation of superficial effects

    Time frame: up to 3 weeks

    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

Secondary outcomes

  1. Adverse event collection as a measure of safety and tolerability

    Time frame: up to 3 weeks

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Aug 19, 2016
Registry last updated
Dec 12, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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