Dermal Irritation, Sensitization and Cumulative Irritation Potential of 6% Bemotrizinol
Condition: Sunburn
MeSH terms: Sunburn
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this clinical trial is to evaluate the dermal safety of Bemotrizinol (6%).
    

Detailed description: 
      The first objective of this study is to 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 dermal irritation and/or induce sensitization following repeated patch application.

      The second objective of this study is to determine the cumulative irritation potential of 6%
      BEMT either in a basic sunscreen oil formulation (SU E 101413 85) or as dispersion in
      petrolatum (SU-E-101413-82) topically applied to the skin of human subjects over a 21-day
      period via a Human Repeat Insult Patch Test (HRIPT).

      HRIPT: This part of the study will consist of an Induction Phase, a Challenge Phase, and, at
      the discretion of the Principal Investigator, a Re-Challenge Phase. During the Induction
      Phase, the test material will be applied to the same location on the back of each subject
      three times per week for a total of nine applications with 24 to 48 hour rest periods. Test
      sites will be examined for dermal irritation at each visit prior to reapplication of the test
      material. Approximately 14 days after the final visit of the Induction Phase, subjects will
      return to the laboratory for the Challenge Phase. The test material will be applied to a
      naïve site on the back under an appropriate patch and will be removed by clinical staff
      approximately 24 hours later. Test sites will be examined for signs of dermal irritation or
      sensitization. A subject may be required to return to the laboratory for a Re-Challenge Test,
      if reactions indicative of sensitization are observed during the Challenge Phase. During the
      Re-Challenge Phase, the test material will be applied to a naïve site under the same
      conditions of the Challenge Phase, and the subject will be examined for dermal reactions.

      Cumulative Irritation Study: A subset of individuals selected for the HRIPT study will also
      participate in the Cumulative Irritation Study. Subjects who meet inclusion and exclusion
      criteria will be enrolled. Subjects will be consented and screened to determine eligibility
      and qualified subjects will be enrolled. Subjects will participate in a 21-day cumulative
      irritation patch study on the back. Test products and vehicle patches, along with a high
      irritancy, a low irritancy and empty patch controls, will be tested during the study.

      At the Day 1 Visit, the upper back of each subject (between the scapulae to either side of
      the spinal midline) will be wiped with 70% isopropyl alcohol and allowed to dry. The empty
      patch, low irritancy 0.9% Saline control and the high irritancy Sodium Lauryl Sulfate 0.1%
      (SLS) control will be used as negative and positive controls, respectively. Controls and test
      products will be applied to the back daily, for approximately 21 days. Patches will remain in
      place for a period of approximately 24 hours. Test sites will be graded following each patch
      removal.

      The vehicle controls (SU E 101413 91 and SU-E-101413-83), 0.9% saline and empty patches as
      negative control will be used for the HRIPT and Cumulative Irritation portion of the study.
      The 0.1% Sodium Laurel Sulfate (SLS) will be only used for the Cumulative Irritation portion
      of the study.

      Approximately 0.2 g of the investigational products and the vehicle control will each be
      applied to the fabric portion of separate patches.

      During the Cumulative Irritation portion of the study, there will be 7 patches (2 product
      patches, 2 vehicle controls, 1 positive control, 1 low-irritancy control, and 1 empty patch).
      The low-irritancy control patch will be a saline patch. The positive control will be a SLS
      patch. The negative control will be an undosed patch.

      During the challenge phase of the HRIPT portion of the study, there will be 6 patches (2
      product patches, 2 vehicle controls. 1 saline control and 1 empty patch), leaving out the
      positive control.

      The patches to be used for this clinical trial will be occlusive strips (manufactured by
      Strukmyer LLC, Mesquite, TX or equivalent), consisting of a breathable tape with non-
      breathable adhesive and center portion of 1.9 cm x 1.9 cm fabric.

      Dermal scores will be reported for each site.

      Safety of the investigational products will be monitored by evaluating adverse event
      reporting.
    

Intervention name(s): 6% Bemotrizinol (BEMT) in a basic sunscreen oil formulation; 6% Bemotrizinol (BEMT) dispersion in petrolatum; Sunscreen oil vehicle with 10% ethanol as penetration enhancer without BEMT; Petrolatum vehicle; 0.9% Saline; Sodium Lauryl Sulfate 0.1% (SLS); Undosed patch
Intervention type(s): Drug; Drug; Other; Other; Other; Other; Other
Intervention description(s): SU E 101413 85; SU-E-101413-82; SU E 101413 91; SU-E-101413-83; low irritancy control; positive control; negative control
Other intervention name(s): PARSOL® SHIELD; PARSOL® SHIELD; Sunscreen oil Vehicle; Vehicle; Saline; control; control
Intervention MeSH terms: Ethanol; Sunscreening Agents; Petrolatum
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Intervention model description: A 21-Day controlled study to evaluate the skin Irritation and sensitization potential of 6% Bemotrizinol (BEMT) in topical products with vehicle controls after repeated patch applications to healthy human participants by following conventional Repeated Insult (HRIPT) and Cumulative Irritation (CIT) methodologies.
Masking: Single (Participant)
Primary purpose: Screening
Keywords: cumulative irritation; irritation; sensitization; Bemotrizinol; Sunscreen