Clinical trial NCT03767400: 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.
Official title: 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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Skin Care
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2018-12-06
Enrollment: 99
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Female Caucasian subjects with Fitzpatrick skin types I-III that meet one of the criteria listed; ages 18-30 years old without acne scars on the face with or without visible cellulite on posterior thigh, or ages 55-75 years old without acne scars on the face with or without visible cellulite on posterior thigh, or ages 18-75 years old with atrophic acne scars.

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: VivoSight software measurements of Epidermal Thickness
timeFrame: Day 1
measure: VivoSight software measurements of surface roughness
timeFrame: Day 1
measure: VivoSight software measurements of redness
timeFrame: Day 1
measure: VivoSight software measurements of attenuation coefficient
timeFrame: Day 1
Secondary outcomes:
measure: Overall Photodamage Score at Day 1
timeFrame: Day 1
measure: Overall Appearance of Fine Lines/Wrinkles Cheek Areas
timeFrame: Day 1
measure: Post-study Dynamic Optical Coherence Tomography (D-OCT) Image Analysis of Epidermal Thickness
timeFrame: Day 1
measure: Post-study D-OCT Image Analysis of Density and Attenuation Coefficient of Epidermis
timeFrame: Day 1
measure: Post-study D-OCT Image Analysis of Density and Attenuation Coefficient of Superficial Dermis
timeFrame: Day 1
measure: Post-study D-OCT Image Analysis of Collagen Fibers
timeFrame: Day 1
measure: Post-study D-OCT Image Analysis of Integrity of Collagen
timeFrame: Day 1
measure: Post-study D-OCT Image Analysis of Score of Vessels
timeFrame: Day 1
measure: Post-study D-OCT Image Analysis of Vascularity Quantification with Thresholds
timeFrame: Day 1
measure: Blinded Independent Physician Assessor Grading of the D-OCT Images of Stratum Corneum Reflectivity
timeFrame: Day 1
measure: Blinded Independent Physician Assessor Grading of the D-OCT images of Upper Dermal Reflectivity
timeFrame: Day 1
measure: Blinded Independent Physician Assessor Grading of the D-OCT Images of Dermoepidermal Contrast
timeFrame: Day 1
measure: Blinded Independent Physician Assessor Grading of the D-OCT images of Vessel Density
timeFrame: Day 1
measure: Antera 3D Images
timeFrame: Day 1
measure: VISIA-CR Images
timeFrame: Day 1
Other outcomes:
Locations:
city: Irvine
country: United States
facility: Skinmedica Clinical Research and Innovation Center
state: California
Study officials:
affiliation: Allergan
name: Lisa Goberdhan
role: PRINCIPAL_INVESTIGATOR
References: