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Study to Assess the Cosmetic Changes in the Facial Skin After Use of a Topical Retinoid Product in Participants With Moderate to Severe Photodamage

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ClinicalTrials.gov Identifier: NCT03302559
Recruitment Status : Completed
First Posted : October 5, 2017
Results First Posted : June 4, 2019
Last Update Posted : June 4, 2019
Sponsor:
Information provided by (Responsible Party):
Allergan

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Skin Care Other: Retinol Complex 0.5 Other: Facial cleanser Other: Moisturizing lotion Other: Sunscreen Device: Skin Imaging Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 29 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : September 18, 2017
Actual Primary Completion Date : April 30, 2018
Actual Study Completion Date : April 30, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cosmetics

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.
Other: Retinol Complex 0.5
Retinol Complex 0.5 topically in the evening.
Other Name: SkinMedica Retinol Complex 0.5

Other: Facial cleanser
Facial cleanser in the morning and in the evening.
Other Name: SkinMedica Facial Cleanser

Other: Moisturizing lotion
Fragrance free moisturizing lotion in the morning and in the evening.
Other Name: Cetaphil Fragrance Free Moisturizing Lotion

Other: Sunscreen
Sunscreen broad spectrum sun protection factor (SPF) 35 topically in the morning and as needed.
Other Name: SkinMedica Essential Defense Mineral Shield Broad Spectrum SPF 35

Device: Skin Imaging
Non-invasive in vivo skin imaging will be taken with the VivoSight Dx Optical Coherence Tomography (OCT) and VivaScope 1500




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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).

  4. 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).

  5. 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).

  6. 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).

  7. 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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Ages Eligible for Study:   40 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03302559


Locations
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United States, California
SkinMedica Clinical Research and Innovation Center
Irvine, California, United States, 92612
Sponsors and Collaborators
Allergan
Investigators
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Principal Investigator: Lisa Goberdhan, B.A. Allergan
  Study Documents (Full-Text)

Documents provided by Allergan:

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Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT03302559     History of Changes
Other Study ID Numbers: SCRIC17-RET05
First Posted: October 5, 2017    Key Record Dates
Results First Posted: June 4, 2019
Last Update Posted: June 4, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Vitamin A
Retinol palmitate
Sunscreening Agents
Radiation-Protective Agents
Protective Agents
Physiological Effects of Drugs
Dermatologic Agents
Vitamins
Micronutrients
Nutrients
Growth Substances
Antioxidants
Molecular Mechanisms of Pharmacological Action
Anticarcinogenic Agents
Antineoplastic Agents