Clinical Evaluation of Day and Night Skin Care Creams Supplemented With MediCell Technology (MCT)'s Composition of Defensins and Supportive Molecules
Condition: Skin Aging; Photoaging of Skin
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a placebo-controlled blinded clinical evaluation of day and night skin care creams
      supplemented by Medicell Technology's composition of defensins and supportive molecules
      determine the skin hydration and anti-aging properties of the topical test articles after
      repeated application to the skin of human subjects.
    

Detailed description: 
      45 participants will be selected to participate in a placebo-controlled blinded trial
      comparing the use of the Full Formulas versus the Null Formulas (2 groups). 15 participants
      will be enrolled at each study site.

      Each participant will test the Test System simultaneously as instructed: The Mask one-to-two
      times a week plus the Cream and the Serum twice daily (morning and evening); the detailed
      Directions are shown in Exhibit 2. The test System will be applied directly on face,
      postauricular and neck skin.

      All study subjects will also be provided with Skinfo Clean But Not Dry cleanser and EltaMD UV
      Pure Broad Spectrum Sun Protective Factor (SPF) 47. Subjects will be instructed to wash their
      face twice daily with the cleanser and apply the sunscreen each morning after application of
      the Test System.

      Both the study subjects and their physicians will be blinded in terms of the treatment group
      (the Full Formula or the Null Formula).

      Subjects will be screening, consented and enrolled according to Good Clinical Practice.

      There will be a 1-week washout of any skin care products deemed to be anti-aging. These
      products would include any using (as a main ingredient) antioxidants, retinol or retinoid,
      alpha hydroxyl acid, peptides, growth factors. Any other products that are to continue to be
      used must have been stable for the last 3 months and must be stable for the 12 weeks of the
      study.

      Before beginning treatment, all participants will undergo medical imaging using the VISIA CA,
      QuantifiCare imaging system or similar non-invasive visual system. Additionally, their skin
      will be assessed for transepidermal water loss, wrinkle depth and elasticity (non invasive
      procedures). Optionally, skin will be tested using non-invasive methods for skin color,
      hydration, sebum content and will be evaluated using ultrasound scanner (DeremaLab Combo or
      similar).

      Skin evaluation will be also performed at baseline, 6 weeks and 12 weeks using the Griffiths
      scale (2) as well as the skin evaluation scales for pores, superficial wrinkles, deep or
      muscle induced wrinkles, and skin radiancy, skin turgor, hyperpigmentation, hypopigmentation,
      erythema and edema in Blinded Evaluator Skin Assessment (Exhibit 3). The evaluation will be
      performed in person by the blinded investigators.

      Subjects will complete a Consumer Questionnaire (Exhibit 4) at baseline, 6 week and 12 week
      visits.

      Weekly phone calls will be made or emails will be sent (+/- 1 week window) to remind subjects
      to fill out compliance log, use mask, emphasize cream is applied before the serum. Follow-up
      appointments reminders will also be sent at this time.
    

Intervention name(s): 2-Minute Reveal Masque; 24/7 Barrier Repair Cream; 8-in-1 BioSerum; Null Formula 2-Minute Reveal Masque; Null Formula 24/7 Barrier Repair Cream; Null Formula 8-in-1 BioSerum
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment