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.

NCT ID: NCT03767400

Last Updated: 2019-10-31

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 99 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-12-07
• Study Completion Date: 2019-07-30

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.

Conditions

Skin Care

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Group A - Young skin (18 - 30 years old)

Assessments will be made after facial cleansing on areas being imaged utilizing VivoSight Dynamic Optical Coherence Tomography (D-OCT). Post-study D-OCT images will be processed with VivoSight software. Assessments of participant's overall photodamage and participant's appearance of fine lines/wrinkles will be measured.

Skin Imaging

Intervention Type: DEVICE

Non-invasive in vivo skin imaging will be taken with the VivoSight D-OCT and the measurements will be acquired post-study utilizing VivoSight software.

Facial Cleanser

Intervention Type: OTHER

Participants will be instructed to remove all makeup from the face and cleanse the face with SkinMedica Facial Cleanser at least 15 minutes prior to investigator assessments and photography, and at least 30 minutes prior to use of D-OCT. Particiapnts in the cellulite group will have the thigh area cleansed with Facial Cleanser at least 15 minutes prior to photography and at least 30 minutes prior to use of D-OCT. For standardization, this procedure will be performed with SkinMedica Facial Cleanser (to remove makeup and cleanse the face and thigh (if applicable)) for all the participants.

Group B - Aged skin (55 - 75 years old)

Assessments will be made after facial cleansing on areas being imaged utilizing VivoSight Dynamic Optical Coherence Tomography (D-OCT). Post-study D-OCT images will be processed with VivoSight software. Assessments of participant's overall photodamage and participant's appearance of fine lines/wrinkles will be measured.

Skin Imaging

Intervention Type: DEVICE

Non-invasive in vivo skin imaging will be taken with the VivoSight D-OCT and the measurements will be acquired post-study utilizing VivoSight software.

Facial Cleanser

Intervention Type: OTHER

Participants will be instructed to remove all makeup from the face and cleanse the face with SkinMedica Facial Cleanser at least 15 minutes prior to investigator assessments and photography, and at least 30 minutes prior to use of D-OCT. Particiapnts in the cellulite group will have the thigh area cleansed with Facial Cleanser at least 15 minutes prior to photography and at least 30 minutes prior to use of D-OCT. For standardization, this procedure will be performed with SkinMedica Facial Cleanser (to remove makeup and cleanse the face and thigh (if applicable)) for all the participants.

Group C - Atrophic acne scars (18 - 75 years old)

Assessments will be made after facial cleansing on areas being imaged utilizing VivoSight Dynamic Optical Coherence Tomography (D-OCT). Post-study D-OCT images will be processed with VivoSight software. Assessments of participant's overall photodamage and participant's appearance of fine lines/wrinkles will be measured.

Skin Imaging

Intervention Type: DEVICE

Non-invasive in vivo skin imaging will be taken with the VivoSight D-OCT and the measurements will be acquired post-study utilizing VivoSight software.

Facial Cleanser

Intervention Type: OTHER

Participants will be instructed to remove all makeup from the face and cleanse the face with SkinMedica Facial Cleanser at least 15 minutes prior to investigator assessments and photography, and at least 30 minutes prior to use of D-OCT. Particiapnts in the cellulite group will have the thigh area cleansed with Facial Cleanser at least 15 minutes prior to photography and at least 30 minutes prior to use of D-OCT. For standardization, this procedure will be performed with SkinMedica Facial Cleanser (to remove makeup and cleanse the face and thigh (if applicable)) for all the participants.

Interventions

Skin Imaging

Non-invasive in vivo skin imaging will be taken with the VivoSight D-OCT and the measurements will be acquired post-study utilizing VivoSight software.

Intervention Type: DEVICE

Facial Cleanser

Participants will be instructed to remove all makeup from the face and cleanse the face with SkinMedica Facial Cleanser at least 15 minutes prior to investigator assessments and photography, and at least 30 minutes prior to use of D-OCT. Particiapnts in the cellulite group will have the thigh area cleansed with Facial Cleanser at least 15 minutes prior to photography and at least 30 minutes prior to use of D-OCT. For standardization, this procedure will be performed with SkinMedica Facial Cleanser (to remove makeup and cleanse the face and thigh (if applicable)) for all the participants.

Intervention Type: OTHER

Other Intervention Names

SkinMedica® Facial Cleanser

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Allergan

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lisa Goberdhan

Role: PRINCIPAL_INVESTIGATOR

Allergan

Locations

Skinmedica Clinical Research and Innovation Center

Irvine, California, United States

Countries

United States

Other Identifiers

SCRIC18-OCT-01

Identifier Type: -

Identifier Source: org_study_id