Phototoxicity Potential of 6% Bemotrizinol
Condition: Phototoxic Response
Study type: Interventional
Phase: Phase 2

Summary: 
      Phototoxicity Potential of Bemotrizinol (6%)
    

Detailed description: 
      This clinical trial will assess the phototoxic potential of a test material, compared to a
      vehicle control and a negative control. The results obtained will determine if 6%
      bemotrizinol (BEMT) either in a basic sunscreen oil formulation SU E 101413 85 or as
      dispersion in petrolatum (SU-E-101413-82) elicit a phototoxic response based on a comparison
      of the reactions obtained (either Phototoxic or non-Phototoxic) on the treated/irradiated,
      treated/non-irradiated and non- treated control sites. Two vehicle controls, i.e. sunscreen
      oil vehicle (SU E 101413 91) and petrolatum (SU E 101413 83), and a negative control will
      also be used as comparators in this clinical trial.

      Duplicate test sites on the back (each approximately 4 cm2) will be identified via use of
      body map demonstrating application sites. Test material will be applied to designated patches
      and affixed to both sides of the back. In addition, 2 sets of patches without test material
      will be applied on 2 sides of the back. One side will be designated for irradiation, and the
      other is used as a treated/non-irradiated, and non-treated/non- irradiated control.

      Approximately 24 hours after application, the patches will be removed and the skin will be
      gently wiped. The Minimal Erythema Dose (MED) will be determined from the five UV-treated
      sub-sites and all of the test sites will be evaluated according to the erythema grading
      scale. For evaluation of phototoxicity, the sites are irradiated with 0.5 of the subject's
      MED (full spectrum wavelengths UVB 290-320 nm and UVA 320-400 nm) followed by 5 J/cm2 UVA
      (320-400nm) using a Schott WG-345 and UG11/1 mm filter to block UVB wavelength 290-320
      nanometers. The sites designated for irradiation will be then irradiated with solar simulated
      light by 0.5 times an individual's MED followed by 5 J/cm2 UVA.

      Statistical analysis will not be performed for this study. Investigational product safety
      will be determined through interpretation of the dermal evaluation scores. Treated and
      control sites will be examined at 24 and 48 hours post-irradiation and graded according to a
      scoring scale.

      If a grade ≥2+ erythema is observed after patch removal on the site designated for
      irradiation, the site will not be irradiated, regardless of the dermal response of the
      non-irradiated site and the subjects will be discontinued by the Principal Investigator from
      the study. The dermal response will be followed up until resolution or until the end of the
      study.

      Dermal scores will be reported for each site. Clinically significant reactions other than
      phototoxic reactions will be recorded and interpreted accordingly and the safety of the
      investigational product will be monitored by evaluating adverse event reporting. An adverse
      event is any untoward medical occurrence, whether or not it is considered clinical trial
      related, including death, experienced by a subject. An event may consist of a disease, an
      exacerbation of a pre-existing illness or condition, an occurrence of an intermittent illness
      or condition, a set of related symptoms or signs, or a single symptom or sign. Any subject
      that presents with a dermal reaction of 3+ or greater will be considered as an adverse event
      and documented accordingly.
    

Intervention name(s): Sunscreen oil with 6% Bemotrizinol; Sunscreen oil vehicle; Dispersion of 6% BEMT in petrolatum; Petrolatum vehicle
Intervention type(s): Drug; Other; Drug; Other
Intervention description(s): Sunscreen oil with 6% BEMT (PARSOL® Shield) and 10% ethanol as penetration enhancer; Sunscreen oil vehicle with 10% ethanol as penetration enhancer without BEMT (BEMT replaced by Isopropylmyristate); Dispersion of 6% BEMT (PARSOL® Shield) in petrolatum; Petrolatum vehicle
Other intervention name(s): PARSOL® SHIELD; SU E 101413 85; SU E 101413 91; PARSOL® SHIELD; SU-E-101413-82; SU-E-101413-83
Intervention MeSH terms: Sunscreening Agents; Petrolatum
Allocation: Non-Randomized
Intervention model: Factorial Assignment
Intervention model description: The potential of BEMT 6% to produce a phototoxic response will be assessed using a preestablished grading scale for erythema and dermal response following the application of approximately 0.15 g or 0.15 ml of each product (4 investigational treatments) on the skin of human subjects, which will then be exposed to UV radiation. Each study arm will include one of the following investigational treatments: a sunscreen oil with 6% BEMT and 10% ethanol as penetration enhancer (SU E 101413 85) as compared to a Sunscreen oil vehicle with 10% ethanol as penetration enhancer without BEMT (SU E 101413 91); a dispersion of 6% BEMT in petrolatum (SU E 101413 82); and petrolatum vehicle (SU E 101413 83).
Masking: Single (Participant)
Primary purpose: Basic Science