Dynamic Optical Coherence Tomography(D-OCT) Aging Study: A Preliminary Evaluation of Structural Differences Between Young and Aged Skin, Cellulite and Atrophic Acne Scars in Female Caucasian Subjects With Fitzpatrick Skin Types I-III Utilizing Non-invasive in Vivo D-OCT.



Status:Recruiting
Healthy:No
Age Range:18 - 75
Updated:1/17/2019
Start Date:December 7, 2018
End Date:March 29, 2019
Contact:Clinical Trials Registry Team
Email:IR-CTRegistration@Allergan.com
Phone:877-277-8566

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Dynamic Optical Coherence Tomography (D-OCT) Aging Study: A Preliminary Evaluation of Structural Differences Between Young and Aged Skin, Cellulite and Atrophic Acne Scars in Female Caucasian Subjects With Fitzpatrick Skin Types I-III Utilizing Non-invasive in Vivo D-OCT.

This single-center clinical study is being conducted over the course of 2 weeks to conduct an
exploratory pilot study as a preliminary evaluation of D-OCT's ability to measure skin
changes from aging. Assess structural differences between young and aged skin on the face. To
identify the structural characteristics of atrophic acne scars relative to normal skin on the
face. To explore characteristics of cellulite relative to normal skin on the thigh in young
and aged skin.


Inclusion Criteria:

- Female Caucasian subjects with Fitzpatrick skin types I-III that meet one of the
criteria listed below:

1. Ages 18-30 years old without acne scars on the face with or without visible
cellulite on posterior thigh, or

2. Ages 55-75 years old without acne scars on the face with or without visible
cellulite on posterior thigh, or

3. Ages 18-75 years old with atrophic acne scars

- Subject has completed an appropriately administered informed consent process which
includes signing the IRB approved consent form.

- Good general health and free of any disease state or physical condition (e.g.
psoriasis, rosacea, scars, tattoos etc.) which, in the investigator's opinion, might
impair evaluations of the test sites or expose the subject to an unacceptable risk by
study participation.

- Willingness to remove all makeup on the day of the visit. Makeup may be applied after
the study visit has been completed.

- Willingness to cleanse their face and remove all face makeup at each scheduled clinic
visit. No other topical products should be applied to the face until the study visit
has been completed.

i. For cellulite subgroup, willingness to have thigh cleansed at each scheduled clinic
visit.

- Willingness to have investigator exams, skin instrumentation measurements, and digital
photos performed on the face and/or thigh (for cellulite subgroup).

- Women of childbearing potential must not be pregnant at the time of the study.

Exclusion Criteria:

- Has any condition that, in the opinion of the investigator, would make it unsafe for
the subject to participate in the study or interfere with their clinical assessments
(including conditions that require the concurrent use of anticoagulants, bleeding
coagulopathies, photosensitivity diseases).

- Individuals with active symptoms of allergy, cold sore or warts, active psoriasis or
eczema, rosacea, sunburn, open wounds, neurotic excoriations, tattoos, or other skin
conditions in the test areas that would interfere with the assessments of this study.

- Individuals who are pregnant.

- 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. history of
severe psoriasis, atopic dermatitis, rosacea, skin cancer, etc.)

- Individuals who have routinely used any of the following topical products,
prescription products, or had any of the listed treatments/procedures within the
listed time frame prior to study entry or will use during study:

1. Any product that the investigator deems that could affect the study objectives.
These include products that address skin imperfections. This does not include a
basic cleanser, moisturizer and sunscreen.(time frame 2 weeks)

2. Chemical peel, microdermabrasion, dermaplaning, or microneedling (time frame 3
months)

3. Retin-A®, Retin-A Micro®, Renova®, Avita®, Tazorac®, Avage® or Differin® or other
similar prescription drugs (time frame 3 months)

4. Cosmetic injections (filler and/or toxins, i.e. Juvederm, Radiesse, Botox, etc.),
non-ablative laser or fractional laser resurfacing (time frame 12 months)

5. Accutane® or other oral retinoid, Ablative procedures (i.e. laser, chemical)
(time frame 12 months)

- Individuals who have any planned surgeries or procedures during the study.

- Individuals who participated in a facial usage study within the last 30 days, or who
are currently participating on another usage study.

- Individuals 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
1
site
Irvine, California 92612
Phone: 714-246-3036
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mi
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Irvine, CA
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