Investigating the Wrinkle Reduction Potential of a Novel Compounded Skin Care Cream
Schlüsselwörter
Abstrakt
Beschreibung
Patients will be advised to discontinue any other products, other than a mild cleanser, prior to beginning treatment. Patients will engage in a split face trial, where each participant uses the vehicle on one side of the face and active ingredient treatment cream on the other side. Baseline facial photography and OCT imaging will be performed on both sides of the face. One side of the face will be randomly chosen as the treatment side, and the other as an intrinsic control. Each day, the participant will wash their face in the morning with a standard cleanser, dry their face, then apply the medication to one side of their face and the vehicle to the other side of their face. The patient will then apply a standardized sunscreen SPF 30 to the entire face. Each night, the patient will again wash their face with the standard cleanser, and apply the two medications to the proper sides of the face. Patients will participate in a follow-up clinic visit 4 weeks, 8 weeks, 12 weeks and 16 weeks after beginning treatment. At each visit, photographs and OCT images will be taken of both sides of the face. At week 12, participants will take a survey to determine their satisfaction with the product and their subjective assessment of their skin changes and stop using the products and continue only the sunscreen. Four weeks after cessation of using the creams, they will return for photography and OCT imaging at a final visit.
Termine
Zuletzt überprüft: | 04/30/2020 |
Zuerst eingereicht: | 03/13/2019 |
Geschätzte Einschreibung eingereicht: | 03/13/2019 |
Zuerst veröffentlicht: | 03/17/2019 |
Letztes eingereichtes Update: | 05/25/2020 |
Letztes Update veröffentlicht: | 05/26/2020 |
Tatsächliches Startdatum der Studie: | 03/31/2019 |
Geschätztes primäres Abschlussdatum: | 09/30/2021 |
Voraussichtliches Abschlussdatum der Studie: | 10/31/2021 |
Zustand oder Krankheit
Intervention / Behandlung
Combination Product: Compounded Skin Care Cream
Drug: Placebo
Phase
Armgruppen
Arm | Intervention / Behandlung |
---|---|
Experimental: Compounded Skin Care Cream One side of the face will be randomly chosen as the treatment side | Combination Product: Compounded Skin Care Cream The skin care regimen we will be testing includes ingredients such Hyaluronic acid 1%, Vitamin E Acetate, Vitamin A Acetate, Co-enzyme Q 10, L-Arginine, L-glutamine, Phytonadione, Argireline Peptide solution, GABA, Vitamin C, glycolic acid, and Fenugreek. |
Placebo Comparator: Placebo The other side of the face will be randomly chosen as the control | Drug: Placebo The placebo will be a formula with no active ingredients |
Zulassungskriterien
Altersberechtigt für das Studium | 20 Years Zu 20 Years |
Studienberechtigte Geschlechter | All |
Akzeptiert gesunde Freiwillige | Ja |
Kriterien | Inclusion Criteria: 1. Ages 20 to 60 Exclusion Criteria: 1. Under age 20 2. Over age 60 3. Skin conditions such as rosacea, eczema, and allergic contact dermatitis limited to their face 4. Allergies to products being tested 5. Use of a facial anti-aging product within the past 6 weeks |
Ergebnis
Primäre Ergebnismaße
1. Reduction in Facial Wrinkle Count [16 weeks]
Sekundäre Ergebnismaße
1. Reduction in Skin Roughness [16 weeks]