- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03302559
Study to Assess the Cosmetic Changes in the Facial Skin After Use of a Topical Retinoid Product in Participants With Moderate to Severe Photodamage
June 3, 2019 updated by: Allergan
Assessing the Cosmetic Changes in the Facial Skin Utilizing Non-Invasive In Vivo Skin Imaging Instrumentation After Use of a Topical Retinoid Product In Subjects With Moderate to Severe Photodamage
This study will assess the cosmetic changes of a cosmetic topical retinoid product in participants with moderate to severe photodamage utilizing non-invasive in vivo skin imaging instrumentation.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
29
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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California
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Irvine, California, United States, 92612
- Skinmedica Clinical Research and Innovation Center
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
38 years to 68 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Participants with Fitzpatrick skin type I-IV
- Presence of moderate to severe facial photodamage
- Participants taking hormone replacement or hormones for birth control, willing to stop or change this medication for the duration of the study
- Willingness to cleanse the face and remove all makeup at least 15 minutes prior to each scheduled clinic visit
- Willingness to not use any other products, including self-tanners on their facial skin during the study
- 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. Participants are asked to wear protective clothing prior to and during exposure.
Exclusion Criteria:
- 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
- Individuals who are nursing, pregnant, or planning to become pregnant during the study
- Individuals with uncontrolled disease such as diabetes, hypertension, hyper or hypothyroidism, 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 the study
- Chemical peel or microdermabrasion within 4 weeks of study start
- Retin-A®, Retin-A Micro®, Renova®, Avita®,Tazorac®, Avage® or Differin® or other similar prescription drugs within 3 months of study start
- Cosmetic injections (filler and/or toxins, i.e. Juvederm, Radiesse, Botox, etc.), non-ablative laser or fractional laser resurfacing
- Accutane® or other oral retinoid, Ablative procedures (i.e. laser, chemical, cosmetic surgeries) within 12 months of study start
- Participants who have planned surgeries or procedures.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Retinol Complex 0.5
During a 2-week washout period the participant used a basic skin care regimen (SkinMedica facial cleanser in the morning and in the evening, Cetaphil Fragrance Free Moisturizing Lotion in the morning and in the evening and SkinMedica Essential Defense Mineral Shield Broad Spectrum SPF 35 Sunscreen in the morning and as needed), followed by the same basic skin care regimen plus SkinMedica Retinol Complex 0.5 applied topically to the face in the evening for 12 Weeks.
Assessments of the participant's facial skin were made utilizing investigator clinical grading, digital photography, a spectrophotometer and in vivo skin imaging.
|
Retinol Complex 0.5 topically in the evening.
Other Names:
Facial cleanser in the morning and in the evening.
Other Names:
Fragrance free moisturizing lotion in the morning and in the evening.
Other Names:
Sunscreen broad spectrum sun protection factor (SPF) 35 topically in the morning and as needed.
Other Names:
Non-invasive in vivo skin imaging will be taken with the VivoSight Dx Optical Coherence Tomography (OCT) and VivaScope 1500
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change From Baseline in Overall Photodamage Score
Time Frame: Baseline (Day 1) to Week 12
|
The investigator assessed the participant's overall photodamage using a 10-point scale where None (0)= Facial skin is smooth to the touch, without significant fine/coarse line or skin tone unevenness in any areas (periocular, cheeks, forehead and perioral areas) to Severe (7 to 9)= Facial skin shows 3 or more areas (periocular, cheeks, forehead and perioral areas) of significant roughness, skin tone unevenness (red/brown), or fine/coarse lines at Baseline and Week 12.
A decrease in score indicates improvement.
A negative change from Baseline indicates improvement.
|
Baseline (Day 1) to Week 12
|
Change From Baseline in Appearance of Fine Lines/Wrinkles Score (Forehead, Periocular, Cheeks and Perioral Areas Individually Assessed)
Time Frame: Baseline (Day 1) to Week 12
|
The investigator assessed the participant's appearance of fine lines/wrinkles using a 10-point scale where None (0)= No fine lines/wrinkles present; skin looks completely smooth and wrinkle-free to Severe (7 to 9)= Many coarse lines/wrinkles densely packed together in the treatment area (forehead, periocular, cheeks and perioral areas) at Baseline and Week 12.
A decrease in score indicates improvement.
A negative change from Baseline indicates improvement.
|
Baseline (Day 1) to Week 12
|
Change From Baseline in Appearance of Coarse Lines/Wrinkles Score (Forehead, Periocular, Cheeks and Perioral Areas Individually Assessed)
Time Frame: Baseline (Day 1) to Week 12
|
The investigator assessed the participant's appearance of coarse lines/wrinkles using a 10-point scale where None (0)= No coarse lines/wrinkles present; skin looks completely smooth and wrinkle-free to Severe (7 to 9)= Many coarse lines/wrinkles densely packed together in the treatment area (forehead, periocular, cheeks and perioral areas) at Baseline and Week 12.
A decrease in score indicates improvement.
A negative change from Baseline indicates improvement.
|
Baseline (Day 1) to Week 12
|
Change From Baseline in Tactile Roughness Score
Time Frame: Baseline (Day 1) to Week 12
|
The investigator assessed the participant's tactile roughness in the entire face using a 10-point scale where None (0)= No roughness of the treatment area; skin is completely smooth and pliable to Severe (7 to 9)= Marked roughness of the treatment area associated with stiff feeling at Baseline and Week 12.
A decrease in score indicates improvement.
A negative change from Baseline indicates improvement.
|
Baseline (Day 1) to Week 12
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change From Baseline in Skin Roughness Score Using the Allergan Skin Roughness Visual Scale
Time Frame: Baseline (Day 1) to Week 12
|
The investigator assessed the participant's skin roughness using the Allergan Skin Roughness Visual 5-Point Scale where None (0)= Smooth visual skin texture to Extreme (4)= Extremely coarse visual skin texture, crosshatched deep creases; extreme elastosis at Baseline and Week 12.
A decrease in score indicates improvement.
A negative change from Baseline indicates improvement.
|
Baseline (Day 1) to Week 12
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Change From Baseline in Appearance of Fine Lines Score Using the Allergan Fine Lines Visual Scale
Time Frame: Baseline (Day 1) to Week 12
|
The investigator assessed the participant's fine lines using the Allergan Fine Lines Visual 5-Point Scale where None (0)= No fine lines to Diffuse (4)= Diffuse superficial lines; crosshatching at Baseline and Week 12.
A decrease in score indicates improvement.
A negative change from Baseline indicates improvement.
|
Baseline (Day 1) to Week 12
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Investigator's Global Improvement Assessment for Overall Photodamage
Time Frame: Baseline (Day 1) to Week 12
|
The investigator assessed the global improvement in the participant's overall photodamage compared to Baseline using a 5-point scale where None (0)= No change or worsening to Complete (4)= Almost complete improvement of the condition with a trace of signs/symptoms remaining (approximately 95% or better overall improvement).
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Baseline (Day 1) to Week 12
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Investigator's Global Improvement Assessment for the Appearance of Fine Lines/Wrinkles (Forehead, Periocular, Cheeks, Perioral Areas Individually Assessed)
Time Frame: Baseline (Day 1) to Week 12
|
The investigator assessed the global improvement in the participant's overall appearance of fine lines/wrinkles compared to Baseline using a 5-point scale where None (0)= No change or worsening to Complete (4)= Complete clearing in the appearance of fine lines/wrinkles (approximately 95% or better overall improvement).
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Baseline (Day 1) to Week 12
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Investigator's Global Improvement Assessment for the Appearance of Coarse Lines/Wrinkles (Forehead, Periocular, Cheeks, Perioral Areas Individually Assessed)
Time Frame: Baseline (Day 1) to Week 12
|
The investigator assessed the global improvement in the participant's overall appearance of coarse lines/wrinkles compared to Baseline using a 5-point scale where None (0)= No change or worsening to Complete (4)= Complete clearing in the appearance of coarse lines/wrinkles (approximately 95% or better overall improvement).
|
Baseline (Day 1) to Week 12
|
Investigator's Global Improvement Assessment for Tactile Roughness
Time Frame: Baseline (Day 1) to Week 12
|
The investigator assessed the global improvement in the participant's overall tactile roughness compared to Baseline using a 5-point scale where None (0)= No change or worsening to Complete (4)= Complete clearing in the appearance of tactile roughness (approximately 95% or better overall improvement).
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Baseline (Day 1) to Week 12
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Change From Baseline in Spectrophotometer L* Value (a Measurement of Skin Brightness)
Time Frame: Baseline (Day 1) to Week 12
|
Triplicate spectrophotometer readings were taken of the participant's face (Normal Skin and Target Lesions) at Baseline and Week 12. L* value scores range from 0=black to 100=white.
An increase in the spectrophotometer L* values indicates improvement.
A positive change from Baseline indicates improvement.
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Baseline (Day 1) to Week 12
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Lisa Goberdhan, B.A., Allergan
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 18, 2017
Primary Completion (Actual)
April 30, 2018
Study Completion (Actual)
April 30, 2018
Study Registration Dates
First Submitted
October 2, 2017
First Submitted That Met QC Criteria
October 2, 2017
First Posted (Actual)
October 5, 2017
Study Record Updates
Last Update Posted (Actual)
June 4, 2019
Last Update Submitted That Met QC Criteria
June 3, 2019
Last Verified
June 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SCRIC17-RET05
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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