Investigating the Wrinkle Reduction Potential of a Novel Compounded Skin Care Cream
Condition: Skin Care
Study type: Interventional
Phase: Early Phase 1

Summary: 
      In the realm of cosmetics, skin care accounts for a significant share accounting for 35.3% of
      the global market, creating a $121 billion industry. While many of the products claim to have
      unique, natural formulations that boost skin care, many products contain chemicals that are
      potentially damaging to skin. Such ingredients include preservatives, parabens, fragrances,
      and formaldehyde, which can cause skin irritation and inflammation. Although these
      ingredients help to preserve the stability and longevity of products, it is plausible to
      achieve efficacy and improve skin structure without risking unnecessary damage.

      The condition and health of the dermis rely largely on elastin, which gives the skin its
      elasticity, and collagen, which provides structure and strength. Collagen deteriorates
      naturally with age and exposure to environmental elements such as sunlight and toxins. Many
      skin rejuvenating interventions have focused on preventing the loss of collagen and elastin.
      The formulations used in this study will try to optimize cellular physiology, which in turn
      will create improvement in skin function, collagen strength, and wrinkle depth reduction. The
      skin care regimen we will be testing includes ingredients such Hyaluronic acid 1%, Vitamin E
      Acetate, Vitamin A Acetate, Co-enzyme Q 10, L-Arginine, L-glutamine, Phytonadione, Argireline
      Peptide solution, GABA, Vitamin C, glycolic acid, and Fenugreek. The chemicals used
      commercially have been avoided in this formulation to enhance the beneficial effects of the
      product.

      The purpose of the study is to investigate the efficacy of a new skin care product utilizing
      the tools of complexion analysis software and optical coherence tomography(OCT). The primary
      endpoint will be a 15% reduction in facial wrinkles measured by complexion analysis software.
      Secondary endpoints will be a 10% reduction in skin roughness measured by OCT
    

Detailed description: 
      Patients will be advised to discontinue any other products, other than a mild cleanser, prior
      to beginning treatment. Patients will engage in a split face trial, where each participant
      uses the vehicle on one side of the face and active ingredient treatment cream on the other
      side. Baseline facial photography and OCT imaging will be performed on both sides of the
      face. One side of the face will be randomly chosen as the treatment side, and the other as an
      intrinsic control. Each day, the participant will wash their face in the morning with a
      standard cleanser, dry their face, then apply the medication to one side of their face and
      the vehicle to the other side of their face. The patient will then apply a standardized
      sunscreen SPF 30 to the entire face. Each night, the patient will again wash their face with
      the standard cleanser, and apply the two medications to the proper sides of the face.
      Patients will participate in a follow-up clinic visit 4 weeks, 8 weeks, 12 weeks and 16 weeks
      after beginning treatment. At each visit, photographs and OCT images will be taken of both
      sides of the face. At week 12, participants will take a survey to determine their
      satisfaction with the product and their subjective assessment of their skin changes and stop
      using the products and continue only the sunscreen. Four weeks after cessation of using the
      creams, they will return for photography and OCT imaging at a final visit.
    

Intervention name(s): Skin Care Cream; Placebo
Intervention type(s): Combination Product; Drug
Intervention description(s): The skin care regimen we will be testing includes ingredients such Hyaluronic acid 1%, Vitamin E Acetate, Vitamin A Acetate, Co-enzyme Q 10, L-Arginine, L-glutamine, Phytonadione, Argireline Peptide solution, GABA, Vitamin C, glycolic acid, and Fenugreek.; The placebo will be a formula with no active ingredients
Allocation: Randomized
Intervention model: Single Group Assignment
Intervention model description: Patients will engage in a split face trial, where each participant uses the vehicle on one side of the face and active ingredient treatment cream on the other side
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment