Skin CareNCT03767400
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.
An observational study of Skin Care, run by Allergan at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Skin Care
- What is being tested?
- Skin Imaging and Facial Cleanser
- Type of treatment
- Medical device
- How many people
- 99 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Dec 2018to 30 Jul 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Female Caucasian subjects with Fitzpatrick skin types I-III that meet one of the criteria listed below:
- 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
- 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.
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- 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.
- 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.
Who cannot join
- 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:
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- 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)
- Chemical peel, microdermabrasion, dermaplaning, or microneedling (time frame 3 months)
- Retin-A®, Retin-A Micro®, Renova®, Avita®, Tazorac®, Avage® or Differin® or other similar prescription drugs (time frame 3 months)
- Cosmetic injections (filler and/or toxins, i.e. Juvederm, Radiesse, Botox, etc.), non-ablative laser or fractional laser resurfacing (time frame 12 months)
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Skinmedica Clinical Research and Innovation Center
Irvine, California, 92612
About this study
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.
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
- Being tested
- Skin Imaging, Facial Cleanser
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Skin ImagingDevice
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 CleanserOther
Also called SkinMedica® 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Skin Imaging; Other: Facial Cleanser | |
| 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. Receives: Device: Skin Imaging; Other: Facial Cleanser | |
| 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. Receives: Device: Skin Imaging; Other: Facial Cleanser |
What is being measured
The primary outcome is the main question the study is designed to answer.
VivoSight software measurements of Epidermal Thickness
Epidermal thickness will be measured in microns.
Measured: Day 1
VivoSight software measurements of surface roughness
Surface roughness measurements (Ra, Rq, Rz) will be measured in microns.
Measured: Day 1
VivoSight software measurements of redness
Redness will be measured in percent
Measured: Day 1
VivoSight software measurements of attenuation coefficient
Attenuation coefficient will be measured in AU (arbitrary unit)
Measured: Day 1
Secondary outcomes (15)
Overall Photodamage Score at Day 1
The Investigator will assess the participant's overall photodamage using a 10-point scale where (0) = None to (9) = Severe).
Measured: Day 1
Overall Appearance of Fine Lines/Wrinkles Cheek Areas
The investigator will assess the participant's appearance of fine lines/wrinkles using a 5-point scale from (0=None to 4=Diffuse).
Measured: Day 1
Post-study Dynamic Optical Coherence Tomography (D-OCT) Image Analysis of Epidermal Thickness
Post-study D-OCT image analysis will be done (at the sponsor's discretion) by an independent physician expert.
Measured: Day 1
Post-study D-OCT Image Analysis of Density and Attenuation Coefficient of Epidermis
Post-study D-OCT image analysis will be done (at the sponsor's discretion) by an independent physician expert.
Measured: Day 1
Post-study D-OCT Image Analysis of Density and Attenuation Coefficient of Superficial Dermis
Post-study D-OCT image analysis will be done (at the sponsor's discretion) by an independent physician expert.
Measured: Day 1
Post-study D-OCT Image Analysis of Collagen Fibers
Post-study D-OCT image analysis will be done (at the sponsor's discretion) by an independent physician expert. Measured as normal or in bundles.
Measured: Day 1
Post-study D-OCT Image Analysis of Integrity of Collagen
Post-study D-OCT image analysis will be done (at the sponsor's discretion) by an independent physician expert. Measure as (few, moderate, or many fragments).
Measured: Day 1
Post-study D-OCT Image Analysis of Score of Vessels
Post-study D-OCT image analysis will be done (at the sponsor's discretion) by an independent physician expert. Measured at 300 and 500 microns.
Measured: Day 1
Post-study D-OCT Image Analysis of Vascularity Quantification with Thresholds
Post-study D-OCT image analysis will be done (at the sponsor's discretion) by an independent physician expert. Measured at 300 and 500 microns depth.
Measured: Day 1
Blinded Independent Physician Assessor Grading of the D-OCT Images of Stratum Corneum Reflectivity
Grading (0 = absent to 3 = high).
Measured: Day 1
Blinded Independent Physician Assessor Grading of the D-OCT images of Upper Dermal Reflectivity
Grading (0 = absent to 3 = high).
Measured: Day 1
Blinded Independent Physician Assessor Grading of the D-OCT Images of Dermoepidermal Contrast
Grading (0 = absent to 3 = high).
Measured: Day 1
Blinded Independent Physician Assessor Grading of the D-OCT images of Vessel Density
Grading (0 = no vessels to 3 = many vessels).
Measured: Day 1
Antera 3D Images
The investigator will capture 3D images utilizing the Antera 3D.
Measured: Day 1
VISIA-CR Images
The investigator will capture standardized digital photographs utilizing the VISIA-CR.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2018
- Study start7 Dec 2018
- Primary completion31 May 2019
- Study completion30 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin CareStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allergan
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lisa Goberdhan, Principal investigator, Allergan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03767400
- Sponsor's protocol ID
- SCRIC18-OCT-01
- Status last verified
- Oct 2019
- First submitted
- 5 Dec 2018
- Last updated
- 31 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT03767400
- Acronym / sponsor ID
- SCRIC18-OCT-01
- Conditions
- Skin Care
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- AllerganIndustry (pharma, biotech, devices)
- Study start
- 7 Dec 2018 (actual)
- Primary completion
- 31 May 2019 (actual)
- Study completion
- 30 Jul 2019 (actual)
- First posted
- 6 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A - Young skin (18 - 30 years old) | – | Device: Skin Imaging, Other: Facial CleanserAssessments 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. |
| Group B - Aged skin (55 - 75 years old) | – | Device: Skin Imaging, Other: Facial CleanserAssessments 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. |
| Group C - Atrophic acne scars (18 - 75 years old) | – | Device: Skin Imaging, Other: Facial CleanserAssessments 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (11 listed)
- Female Caucasian subjects with Fitzpatrick skin types I-III that meet one of the criteria listed below:
- 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.
Key exclusion criteria (14 listed)
- 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.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Skin ImagingNon-invasive in vivo skin imaging will be taken with the VivoSight D-OCT and the measurements will be acquired post-study utilizing VivoSight software. | Device | Group A - Young skin (18 - 30 years old), Group B - Aged skin (55 - 75 years old), Group C - Atrophic acne scars (18 - 75 years old) |
| Facial CleanserAlso: SkinMedica® Facial CleanserParticipants 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. | Other | Group A - Young skin (18 - 30 years old), Group B - Aged skin (55 - 75 years old), Group C - Atrophic acne scars (18 - 75 years old) |
Primary outcome
VivoSight software measurements of Epidermal Thickness
Time frame: Day 1
Epidermal thickness will be measured in microns.
VivoSight software measurements of surface roughness
Time frame: Day 1
Surface roughness measurements (Ra, Rq, Rz) will be measured in microns.
VivoSight software measurements of redness
Time frame: Day 1
Redness will be measured in percent
VivoSight software measurements of attenuation coefficient
Time frame: Day 1
Attenuation coefficient will be measured in AU (arbitrary unit)
15 secondary outcomes
Overall Photodamage Score at Day 1
Time frame: Day 1
Overall Appearance of Fine Lines/Wrinkles Cheek Areas
Time frame: Day 1
Post-study Dynamic Optical Coherence Tomography (D-OCT) Image Analysis of Epidermal Thickness
Time frame: Day 1
Post-study D-OCT Image Analysis of Density and Attenuation Coefficient of Epidermis
Time frame: Day 1
Post-study D-OCT Image Analysis of Density and Attenuation Coefficient of Superficial Dermis
Time frame: Day 1
Post-study D-OCT Image Analysis of Collagen Fibers
Time frame: Day 1
Post-study D-OCT Image Analysis of Integrity of Collagen
Time frame: Day 1
Post-study D-OCT Image Analysis of Score of Vessels
Time frame: Day 1
Post-study D-OCT Image Analysis of Vascularity Quantification with Thresholds
Time frame: Day 1
Blinded Independent Physician Assessor Grading of the D-OCT Images of Stratum Corneum Reflectivity
Time frame: Day 1
Blinded Independent Physician Assessor Grading of the D-OCT images of Upper Dermal Reflectivity
Time frame: Day 1
Blinded Independent Physician Assessor Grading of the D-OCT Images of Dermoepidermal Contrast
Time frame: Day 1
Blinded Independent Physician Assessor Grading of the D-OCT images of Vessel Density
Time frame: Day 1
Antera 3D Images
Time frame: Day 1
VISIA-CR Images
Time frame: Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lisa Goberdhan principal investigator
Allergan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Skin Care, run by Allergan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VivoSight software measurements of Epidermal Thickness (time frame: Day 1). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2019.