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

NCT03302559 | Completed Results FDA Device

• 1 other identifier: SCRIC17-RET05
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

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.

Conditions

Skin Care

Outcome Measures

Primary Outcomes (4)

• Change From Baseline in Overall Photodamage Score

  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)

  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)

  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

  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

Secondary Outcomes (7)

• Change From Baseline in Skin Roughness Score Using the Allergan Skin Roughness Visual Scale

  Baseline (Day 1) to Week 12

• Change From Baseline in Appearance of Fine Lines Score Using the Allergan Fine Lines Visual Scale

  Baseline (Day 1) to Week 12

• Investigator's Global Improvement Assessment for Overall Photodamage

  Baseline (Day 1) to Week 12

• Investigator's Global Improvement Assessment for the Appearance of Fine Lines/Wrinkles (Forehead, Periocular, Cheeks, Perioral Areas Individually Assessed)

  Baseline (Day 1) to Week 12

• Investigator's Global Improvement Assessment for the Appearance of Coarse Lines/Wrinkles (Forehead, Periocular, Cheeks, Perioral Areas Individually Assessed)

  Baseline (Day 1) to Week 12

Study Arms (1)

Retinol Complex 0.5

EXPERIMENTAL

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; Other: Facial cleanser; Other: Moisturizing lotion; Other: Sunscreen; Device: Skin Imaging

Interventions

Retinol Complex 0.5 OTHER

Retinol Complex 0.5 topically in the evening.

Also known as: SkinMedica Retinol Complex 0.5

Retinol Complex 0.5

Facial cleanser OTHER

Facial cleanser in the morning and in the evening.

Also known as: SkinMedica Facial Cleanser

Retinol Complex 0.5

Moisturizing lotion OTHER

Fragrance free moisturizing lotion in the morning and in the evening.

Also known as: Cetaphil Fragrance Free Moisturizing Lotion

Retinol Complex 0.5

Sunscreen OTHER

Sunscreen broad spectrum sun protection factor (SPF) 35 topically in the morning and as needed.

Also known as: SkinMedica Essential Defense Mineral Shield Broad Spectrum SPF 35

Retinol Complex 0.5

Skin Imaging DEVICE

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

Retinol Complex 0.5

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Allergan: lead

Study Sites (1)

SkinMedica Clinical Research and Innovation Center

Irvine, California, 92612, United States

Location

MeSH Terms

Interventions

Sunscreening Agents

Intervention Hierarchy (Ancestors)

Radiation-Protective Agents; Protective Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Dermatologic Agents; Therapeutic Uses; Cosmetics; Specialty Uses of Chemicals

Results Point of Contact

• Title: Therapeutic Area, Head
• Organization: Allergan

clinicaltrials@allergan.com

714-246-4500

Study Officials

• Lisa Goberdhan, B.A.

  Allergan

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 2, 2017
• First Posted: October 5, 2017
• Study Start: September 18, 2017
• Primary Completion: April 30, 2018
• Study Completion: April 30, 2018
• Last Updated: June 4, 2019
• Results First Posted: June 4, 2019

Record last verified: 2019-06

Locations

US (1)