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

NCT ID: NCT03302559

Last Updated: 2019-06-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 29 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-18
• Study Completion Date: 2018-04-30

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Retinol Complex 0.5

Intervention Type: OTHER

Retinol Complex 0.5 topically in the evening.

Facial cleanser

Intervention Type: OTHER

Facial cleanser in the morning and in the evening.

Moisturizing lotion

Intervention Type: OTHER

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

Sunscreen

Intervention Type: OTHER

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

Skin Imaging

Intervention Type: DEVICE

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

Interventions

Retinol Complex 0.5

Retinol Complex 0.5 topically in the evening.

Intervention Type: OTHER

Facial cleanser

Facial cleanser in the morning and in the evening.

Intervention Type: OTHER

Moisturizing lotion

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

Intervention Type: OTHER

Sunscreen

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

Intervention Type: OTHER

Skin Imaging

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

Intervention Type: DEVICE

Other Intervention Names

SkinMedica Retinol Complex 0.5; SkinMedica Facial Cleanser; Cetaphil Fragrance Free Moisturizing Lotion; SkinMedica Essential Defense Mineral Shield Broad Spectrum SPF 35

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Allergan

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lisa Goberdhan, B.A.

Role: PRINCIPAL_INVESTIGATOR

Allergan

Locations

SkinMedica Clinical Research and Innovation Center

Irvine, California, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

SCRIC17-RET05

Identifier Type: -

Identifier Source: org_study_id