Status:
COMPLETED
Study to Assess the Cosmetic Changes in the Facial Skin After Use of a Topical Retinoid Product in Participants With Moderate to Severe Photodamage
Lead Sponsor:
Allergan
Conditions:
Skin Care
Eligibility:
All Genders
40-70 years
Phase:
NA
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
- 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
- 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.
Key Trial Info
Start Date :
September 18 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 30 2018
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT03302559
Start Date
September 18 2017
End Date
April 30 2018
Last Update
June 4 2019
Active Locations (1)
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1
SkinMedica Clinical Research and Innovation Center
Irvine, California, United States, 92612