To Evaluate Skin Irritation and Skin Sensitisation of Developmental Cosmetic Facial Products
Condition: Skin Care
Study type: Interventional

Summary: 
      The aim of this study is to assess irritant or allergic response of 3 developmental cosmetic
      facial products following a conventional human repeated insult patch test methodology for 6
      weeks.
    

Detailed description: 
      A randomized, single blind (evaluator), single-center, Human Repeat Insult Patch Test (HRIPT)
      study in healthy adult participants aged 18 to 65 years to evaluate the cutaneous irritation
      and contact sensitization potential of 3 cosmetic facial skincare products. The participants
      will undergo repeated cutaneous application of semi-occlusive patch of 3 cosmetic facial
      skincare products and a reference product as a negative control (saline solution). HRIPT is a
      long standing, standard method to determine whether exposure to a topical product will elicit
      a cutaneous (dermal) irritant or allergic response (sensitization) under exaggerated
      (occluded) conditions. Screening of the participants will be performed at Visit 1 (i.e. from
      Day 0 to Day 14). The study will progress in 3-phases: Induction phase, Rest Phase and
      Challenge Phase. The Induction phase will continue for 3 consecutive weeks (Visit 2 to Visit
      10); at visit 2, the area for patch application will be designated between the scapula and
      waistline, away from the spinal mid-line. A controlled amount (0.02 milliliters per
      centimeters square [mL/cm^2]) of each study product will be randomly assigned within the
      patch system of each participant into the appropriate separate cell (3 cells for each of the
      test products and 1 cell for the saline solution). Each patch will remain in place for 48 (±
      4) hours on weekdays and 72 (± 4) hours on weekend. Induction phase will be followed by
      2-week (Visit 11) Rest phase; where there will be no product or patch applications. Rest
      phase is further followed by Challenge phase at week 6 (Visit 12 to Visit 15) in which a
      naïve area of the skin will be selected and a new patch with each of the cells filled with
      study products will be applied. After 48 (±4) hours of patch application, participants will
      return to the site, the patch will be removed, and subsequent test-site evaluations will be
      performed.
    

Intervention name(s): Serum; Lotion; Cream; Normal Saline
Intervention type(s): Other; Other; Other; Other
Intervention description(s): Participants will be topically applied serum to the dorsum, under a semi-occlusive patch (0.02 milliliters per centimeters square [mL/cm^2] of serum in an individual cell of patch); Participants will be topically applied lotion to the dorsum, under a semi-occlusive patch (0.02mL/cm^2 of lotion in an individual cell of patch); Participants will be topically applied cream to the dorsum, under a semi-occlusive patch (0.02mL/cm^2 of cream in an individual cell of patch); Participants will be topically applied normal saline to the dorsum, under a semi-occlusive patch (0.02mL/cm^2 of normal saline in an individual cell of patch)
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The human repeated insult patch test (HRIPT) is a long standing, standard method to determine whether exposure to a topical product will elicit a cutaneous (dermal) irritant or allergic response (sensitization) under exaggerated (occluded) conditions.
Masking: Single (Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Skin Care, Cosmetic Facial Product