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



Status:Completed
Conditions:Other Indications
Therapuetic Areas:Other
Healthy:No
Age Range:30 - Any
Updated:2/1/2019
Start Date:June 4, 2018
End Date:December 3, 2018

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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)


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.
We found this trial at
2
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Houston, TX
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San Diego, California 92121
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San Diego, CA
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