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

NCT02765763 | Completed Phase 4

• 1 other identifier: AFT Defenage
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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 hydration and anti-aging properties of the topical test articles after repeated application to the skin of human subjects.

Conditions

Skin Aging; Photoaging of Skin

Outcome Measures

Primary Outcomes (10)

• Skin Evaluation assessing change from baseline to 12 weeks using Scale from 0 to 4 for pore size

  Baseline and 12 weeks

• Skin Evaluation assessing change from baseline to 12 weeks using Scale from 0 to 4 for superficial wrinkles

  Baseline and 12 weeks

• Skin Evaluation assessing change from baseline to 12 weeks using Scale from 0 to 4 for deep wrinkles

  Baseline and 12 weeks

• Skin Evaluation assessing change from baseline to 12 weeks using Scale from 0 to 4 for skin radiancy

  Baseline and 12 weeks

• Skin Evaluation assessing change from baseline to 12 weeks using Scale from 0 to 4 for skin turgor

  Baseline and 12 weeks

• Skin Evaluation assessing change from baseline to 12 weeks using Scale from 0 to 4 for hyperpigmentation

  Baseline and 12 weeks

• Skin Evaluation assessing change from baseline to 12 weeks using Scale from 0 to 4 for hypopigmentation

  Baseline and 12 weeks

• Skin Evaluation assessing change from baseline to 12 weeks using Scale from 0 to 4 for erythema

  Baseline and 12 weeks

• Skin Evaluation assessing change from baseline to 12 weeks using Scale from 0 to 4 for edema

  Baseline and 12 weeks

• Skin Evaluation assessing change from baseline to 12 weeks using Scale from 0 to 4 for scaling and dryness

  Baseline and 12 weeks

Study Arms (2)

Group 1 Sham

SHAM COMPARATOR

Null Formula of the Test System

Drug: Null Formula 2-Minute Reveal Masque; Drug: Null Formula 24/7 Barrier Repair Cream; Drug: Null Formula 8-in-1 BioSerum

Group 2 Treated

ACTIVE COMPARATOR

Full Formulas of Test System

Drug: 2-Minute Reveal Masque; Drug: 24/7 Barrier Repair Cream; Drug: 8-in-1 BioSerum

Interventions

2-Minute Reveal Masque DRUG

Group 2 Treated

24/7 Barrier Repair Cream DRUG

Group 2 Treated

8-in-1 BioSerum DRUG

Group 2 Treated

Null Formula 2-Minute Reveal Masque DRUG

Group 1 Sham

Null Formula 24/7 Barrier Repair Cream DRUG

Group 1 Sham

Null Formula 8-in-1 BioSerum DRUG

Group 1 Sham

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Advanced Dermatology: lead

Study Sites (1)

Advanced Dermatology, LLC

Lincolnshire, Illinois, 60069, United States

Location

Study Officials

• Amy F Taub, MD

  Advanced Dermatology. LLC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2016
• First Posted: May 9, 2016
• Study Start: May 1, 2016
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2017
• Last Updated: January 11, 2018

Record last verified: 2016-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)