A Photoxicity and Photoallergy Study of a Developmental Face Cream, Serum and Lotion
Condition: Skin Care
Study type: Interventional

Summary: 
      The purpose of this study is to demonstrate the absence of sensitisation and irritation
      potential of a product when applied to the skin and exposed to ultraviolet (UV) radiation.
      Photo-sensitisation potential will primarily be evaluated through a subsequent semi-occluded
      application and UV exposure (challenge phase) after a 2-week rest period. Photo-irritation
      potential will primarily be evaluated through the repeated occluded application and UV
      exposure of the study products over 3 weeks (induction phase).
    

Detailed description: 
      A single-center, randomised, evaluator (single) blind study in healthy adult participants
      aged 18 to 65 years with no dermatological disorders to evaluate the cutaneous photo-
      irritation and photo-sensitisation potential of three cosmetic facial skincare products.
      During Screening (Visit 1), the participants will sign an informed consent, will undergo
      dermatological assessment to ensure they have no dermatoses on their dorsum that might impact
      their safety, Fitzpatrick Phototype of II to IV and colorimetry analysis of their skin type
      using the Individual Typology Angle, which will be used to estimate minimal erythemal dose
      (MED). At Visit 2, the eligible participants will undergo MED irradiation where the
      participant will be administered a series of 6 controlled doses of UV radiation. At Visit 3,
      the participants will undergo MED determination, where a trained evaluator will evaluate the
      exposed skin to determine the lowest dose of UV radiation required to induce uniform,
      unambiguous erythema for signs of visible erythema. Further, the study will progress in
      3-phases: Induction phase, Rest Phase and Challenge Phase. The Induction phase (3 weeks:
      Visit 4 to Visit 18); at visit 4, the area for applying 2 consecutive patches will be
      designated between the scapula and waistline. A controlled amount (0.02 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). Every Monday, patch sites will be evaluated, 2 patches will be applied, post 24
      hours (Tuesday) the patches will be removed, patch sites can be cleaned, patch sites will be
      evaluated, test products/ saline will be re-applied and 1 of the 2 sites will be irradiated
      with 2.5 Joules per centimetre square UVA radiation with a Schott UG11+WG335 filter (or
      equivalent) in place, and then with 0.3 MEDs of UVA+UVB radiation (filters UG11+WG320). The
      sites will be assessed immediately after irradiation and 24 hours post irradiation
      (Wednesday) and duplicate patches will be re-applied as applied on Monday. Same procedure
      will be repeated on Thursday as done on Tuesday and on Friday the patch sites will be
      evaluated. The same process will continue for 3 consecutive weeks. Then there will be 2 weeks
      of Rest phase; where there will be no product or patch applications. Rest phase is further
      followed by Challenge phase at week 6 (Visit 19 to Visit 23) where there will be a duplicate
      parallel series of product applications under semi-occlusive patches to 2 naïve areas on
      Monday. Post 24 hours (Tuesday) patches will be removed and 1 of the 2 sites will be
      irradiated similar as done in induction phase. The sites will be assessed immediately post
      irradiation and after 24 hours (Tuesday), 48 hours (Wednesday) and 72 hours (Thursday) of
      irradiation. At visit 23, after the challenge phase the final assessments will be performed
      by the dermatologist.
    

Intervention name(s): Serum; Lotion; Cream; Normal Saline
Intervention type(s): Other; Other; Other; Other
Intervention description(s): Participants will be topically applied adhesive patch containing developmental serum; Participants will be topically applied adhesive patch containing developmental lotion; Participants will be topically applied adhesive patch containing developmental cream; Participants will be topically applied adhesive patch containing normal saline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Other
Keywords: Skin Care, Cosmetic Facial Product