N/A N=29 Treatment

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

Skin Care

Bottom Line

View on ClinicalTrials.gov: NCT03302559 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jun 2019

Primary outcome: Primary: Change From Baseline in Overall Photodamage Score — 5.6; -0.8 score on a scale — p=<0.001

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Retinol Complex 0.5 (Other); Facial cleanser (Other); Moisturizing lotion (Other); Sunscreen (Other); Skin Imaging (Device)
Age: Adult, Older Adult · 40+ yrs
Sex: All
Sponsor: Allergan
Primary completion: Apr 2018

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline in Overall Photodamage Score	5.6; -0.8	<0.001 sig
PRIMARY Change From Baseline in Appearance of Fine Lines/Wrinkles Score (Forehead, Periocular, Cheeks and Perioral Areas Individually Assessed)	3.4; -0.8; 4.7; -1.0; 3.6; -1.1	0.005 sig
PRIMARY Change From Baseline in Appearance of Coarse Lines/Wrinkles Score (Forehead, Periocular, Cheeks and Perioral Areas Individually Assessed)	4.9; -0.6; 6.0; -0.7; 3.5; -1.1	0.02 sig
PRIMARY Change From Baseline in Tactile Roughness Score	4.0; -1.1	0.002 sig
SECONDARY Change From Baseline in Skin Roughness Score Using the Allergan Skin Roughness Visual Scale	1.8; -0.5	0.0008 sig
SECONDARY Change From Baseline in Appearance of Fine Lines Score Using the Allergan Fine Lines Visual Scale	4.0; -0.3	0.02 sig
SECONDARY Investigator's Global Improvement Assessment for Overall Photodamage	1.5	—
SECONDARY Investigator's Global Improvement Assessment for the Appearance of Fine Lines/Wrinkles (Forehead, Periocular, Cheeks, Perioral Areas Individually Assessed)	1.1; 1.6; 1.3; 1.2	—
SECONDARY Investigator's Global Improvement Assessment for the Appearance of Coarse Lines/Wrinkles (Forehead, Periocular, Cheeks, Perioral Areas Individually Assessed)	0.8; 1.6; 0.9; 0.8	—
SECONDARY Investigator's Global Improvement Assessment for Tactile Roughness	1.3	—
SECONDARY Change From Baseline in Spectrophotometer L* Value (a Measurement of Skin Brightness)	62.0; 0.3; 57.8; 0.3	0.3

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03302559). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.