Clinical Evaluation of Day and Night Skin Care Creams Supplemented With MediCell Technology (MCT)'s Composition of Defensins and Supportive Molecules

Skin Aging Clinical Trial

Official title: Clinical Evaluation of Day and Night Skin Care Creams Supplemented With MediCell Technology (MCT)'s Composition of Defensins and Supportive Molecules

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Photoaging of Skin
• Skin Aging

• NCT number: NCT02765763
• Study type: Interventional
• Source: Advanced Dermatology
• Status: Completed
• Phase: Phase 4
• Start date: May 2016
• Completion date: June 2017