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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Skin Care
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2017-10-05
Enrollment: 29
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Change From Baseline in Overall Photodamage Score
timeFrame: Baseline (Day 1) to Week 12
measure: Change From Baseline in Appearance of Fine Lines/Wrinkles Score (Forehead, Periocular, Cheeks and Perioral Areas Individually Assessed)
timeFrame: Baseline (Day 1) to Week 12
measure: Change From Baseline in Appearance of Coarse Lines/Wrinkles Score (Forehead, Periocular, Cheeks and Perioral Areas Individually Assessed)
timeFrame: Baseline (Day 1) to Week 12
measure: Change From Baseline in Tactile Roughness Score
timeFrame: Baseline (Day 1) to Week 12
Secondary outcomes:
measure: Change From Baseline in Skin Roughness Score Using the Allergan Skin Roughness Visual Scale
timeFrame: Baseline (Day 1) to Week 12
measure: Change From Baseline in Appearance of Fine Lines Score Using the Allergan Fine Lines Visual Scale
timeFrame: Baseline (Day 1) to Week 12
measure: Investigator's Global Improvement Assessment for Overall Photodamage
timeFrame: Baseline (Day 1) to Week 12
measure: Investigator's Global Improvement Assessment for the Appearance of Fine Lines/Wrinkles (Forehead, Periocular, Cheeks, Perioral Areas Individually Assessed)
timeFrame: Baseline (Day 1) to Week 12
measure: Investigator's Global Improvement Assessment for the Appearance of Coarse Lines/Wrinkles (Forehead, Periocular, Cheeks, Perioral Areas Individually Assessed)
timeFrame: Baseline (Day 1) to Week 12
measure: Investigator's Global Improvement Assessment for Tactile Roughness
timeFrame: Baseline (Day 1) to Week 12
measure: Change From Baseline in Spectrophotometer L* Value (a Measurement of Skin Brightness)
timeFrame: Baseline (Day 1) to Week 12
Other outcomes:
Locations:
city: Irvine
country: United States
facility: SkinMedica Clinical Research and Innovation Center
state: California
Study officials:
affiliation: Allergan
name: Lisa Goberdhan, B.A.
role: PRINCIPAL_INVESTIGATOR
References: