Status:
COMPLETED
Clinical Evaluation of Day and Night Skin Care Creams Supplemented With MediCell Technology (MCT)'s Composition of Defensins and Supportive Molecules
Lead Sponsor:
Advanced Dermatology
Conditions:
Skin Aging
Photoaging of Skin
Eligibility:
FEMALE
40-75 years
Phase:
PHASE4
Brief 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 hy...
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 ea...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2017
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT02765763
Start Date
May 1 2016
End Date
June 1 2017
Last Update
January 11 2018
Active Locations (1)
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1
Advanced Dermatology, LLC
Lincolnshire, Illinois, United States, 60069