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



Status:Completed
Conditions:Cosmetic
Therapuetic Areas:Dermatology / Plastic Surgery
Healthy:No
Age Range:40 - 75
Updated:1/13/2018
Start Date:May 2016
End Date:June 2017

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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.

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.

Inclusion Criteria:

- Sex: Female

- Fitzpatrick Skin Types: I-VI

- Age: 40 - 75 years

- Individuals who will be able to read, understand and give an informed consent relation
to the study they are participating in.

- Individuals who will be free of any dermatological or systemic disorder, which in the
Principal Investigator's opinion, could interfere with the study results.

- Individuals who will be in general good health and who will complete a preliminary
medical history form mandated by the clinic.

- Individuals who will be able to and agree to cooperate with the Investigator and
research staff.

- Individuals who will agree to have test products applied in accordance with the
protocol and are able to complete the full course of the study.

- Individuals who will agree to have 2 biopsies on the postauricular area if randomly
selected.

- Individuals who will agree to not participate in any other study during the entire
length of the study and have not participated in a similar study in the past 30 days.

Exclusion Criteria:

- Individuals who are currently taking any medications (topical or systemic) that may
mask or interfere with the test results.

- Individuals who have a history of any acute or chronic disease that might interfere
with or increase the risk on study participation. (e.g., systemic lupus erythematosus,
rheumatoid arthritis, HIV positive).

- Individuals who are diagnosed with chronic skin allergies (atopic dermatitis/eczema)
or recently treated skin cancer within the last 12 months.

- Individuals who control their diabetes using insulin.

- Individuals with any history, which in the Investigator's opinion, indicates the
potential for harm to the subject or places the validity of the study in jeopardy.

- Individuals who indicate that they are pregnant or are planning to become pregnant or
nursing.

- Individuals who have undergone any of the following procedures:

- Botox within 6 months before enrollment into study and until study completion

- Injectable filler within 3 months before enrollment into study and until study
completion

- Lasers or tissue tightening devices (ultherapy, radiofrequency, skin tightening,
microcurrent or photorejuvenation, photodynamic therapy) within 6 months before
enrollment into study and until study completion

- Sculptra or Bellafill prior to enrollment into the study and until study
completion
We found this trial at
1
site
Lincolnshire, Illinois 60069
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mi
from
Lincolnshire, IL
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