Study to Evaluate Efficacy and Tolerability of Two Topical Regimens in Subjects With Moderate to Severe Facial Photodamage Who Have Received Cosmetic Injections

Open-Label, Randomized, Multi-center Study to Evaluate the Efficacy and Tolerability of Two Topical Regimens in Subjects With Moderate to Severe Facial Photodamage Who Have Received Cosmetic Injections

This study will assess the efficacy and tolerability of two topical regimens (containing cosmetic human fibroblast-derived, physiologically-balanced growth factor combination products (HULK and TNS Essential Serum)

Study Overview

• Status: Completed
• Conditions: Facial Photodamage
• Intervention / Treatment: Other: on-label facial injection

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Diego, California, United States, 92121
      • Cosmetic Laser Dermatology
  • Texas
    • Houston, Texas, United States, 77056
      • Suzanne Bruce and Associates, PA, The Center for Skin Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Female subjects aged 30 years and older with Fitzpatrick skin type I-VI
• Pre-elected to receive on-label facial injection(s) (i.e. neuromodulator injection and/or filler injections)
• Experienced injection patients defined as having received at least 1 facial injection in the past 2 years.
• Current users of non-physician-dispensed brand skin care products (i.e. only using products that are available at drugstores or department stores
• Good general health and free of any disease state or physical condition (e.g. psoriasis, rosacea, scars, tattoos etc.)
• Willingness to have exams and digital photos performed on the face.
• Willingness to cooperate and participate by following study requirements (including using the provided test products) for the duration of the study and to report any adverse event symptoms or reactions immediately.
• Willingness to discontinue use of their current skincare products starting at their Week 4 visit in this study.
• Willingness to not use any other products, including self-tanners, on their face for the duration of the study other than make-up with an established tolerance of at least 1 month.
• Willingness to withhold all facial treatments during the course of the study including microdermabrasion, peels, facials, laser treatments and tightening treatments.
• .Willingness to avoid as much as possible, direct and prolonged sun exposure for the duration of the study (including tanning beds), especially from 10 AM to 2 PM. Subjects are asked to wear protective clothing prior to and during exposure.
• If of child-bearing potential, willing to use an acceptable method of contraception throughout the study. Acceptable methods of birth

Exclusion Criteria:

• Who are nursing, pregnant, or planning to become pregnant during the study according to subject self-report.
• Individuals with active symptoms of allergy, cold sore or warts, active psoriasis or eczema, rosacea, sunburn, open wounds, neurotic excoriations, excessive scarring, tattoos, or other skin conditions in the test areas that would interfere with the assessments of this study.
• Uncontrolled disease such as diabetes, hypertension, hyper or hypo-thyroidism, active hepatitis, immune deficiency, or autoimmune.
• Individuals who have a pre-existing or dormant dermatologic condition (e.g., psoriasis, atopic dermatitis, rosacea, skin cancer, etc.)
• Individuals who require electrolysis, waxing, or use depilatories on the face during conduct of the study.
• Individuals with any planned surgeries and/or invasive medical procedures during the course of the study
• Individuals who are currently participating in any other facial usage study or have participated in any clinical trial within 4 weeks prior to inclusion of the study.
• Subjects currently on or planning to participate on any type of research study at another facility or a doctor's office during this study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Treatment Group #1; Subject in Treatment group 1 will apply the following products in the morning and evening.; SkinMedica Facial Cleanser; Hulk (cosmetic investigational); Marvel AM (cosmetic investigational); Marvel PM (cosmetic investigational); SkinMedica HA5 Rejuvenating Hydrator; SkinMedica Rejuvenative Moisturizer; SkinMedica Essential Defense Mineral Shield SPF 35 Sunscreen	Other: on-label facial injection; Assessing if adding SkinMedica's cosmetic topical skincare regimens improves the appearance of the skin and the subject's experience, when used after pre-elected on-label facial injection
EXPERIMENTAL: Treatment group #2; Subject in Treatment group 2 will apply the following products in the morning and evening.; SkinMedica Facial Cleanser; SkinMedica TNS Essential Serum; Marvel AM (cosmetic investigational); Marvel PM (cosmetic investigational); SkinMedica HA5 Rejuvenating Hydrator; SkinMedica Rejuvenative Moisturizer; SkinMedica Essential Defense Mineral Shield SPF 35 Sunscreen	Other: on-label facial injection; Assessing if adding SkinMedica's cosmetic topical skincare regimens improves the appearance of the skin and the subject's experience, when used after pre-elected on-label facial injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline in Clinical grading of the full face on the Griffith's modified 10-point scale	Investigator will assess the following parameters on a Griffith's modified 10-point scale (0 = None, 1 to 3 = Mild, 4 to 6 = Moderate, 7 to 9 = Severe)	Baseline, Week 4, Week 16

Collaborators and Investigators

• Sponsor: Allergan

Publications and helpful links

Helpful Links

• Additional information on study locations near you may be found at AllerganClinicalTrials.com. For any study not on AllerganClinicalTrials.com, please contact IR-CTRegistration@Allergan.com for assistance

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 4, 2018
• Primary Completion (ACTUAL): December 3, 2018
• Study Completion (ACTUAL): December 3, 2018

Study Registration Dates

• First Submitted: May 23, 2018
• First Submitted That Met QC Criteria: June 15, 2018
• First Posted (ACTUAL): June 18, 2018

Study Record Updates

• Last Update Posted (ACTUAL): January 30, 2019
• Last Update Submitted That Met QC Criteria: January 28, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Facies
• Other Study ID Numbers: SKM18-HULK-INJ

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No