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

Allergan

Status: Completed

Conditions: Skin Care

Treatments: Other: Retinol Complex 0.5; Other: Moisturizing lotion; Other: Facial cleanser; Device: Skin Imaging; Other: Sunscreen

Study type: Interventional

Funder types: Industry

Identifiers

NCT03302559

SCRIC17-RET05

Details and patient eligibility

About

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.

Enrollment: 29 patients

Sex: All

Ages: 40 to 70 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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29 participants in 1 patient group

Retinol Complex 0.5

Experimental group

Description:

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.

Treatment:

Other: Sunscreen

Other: Facial cleanser

Other: Moisturizing lotion

Device: Skin Imaging

Other: Retinol Complex 0.5