Open-Label Study Evaluating the Anti-Aging Effects of a 3-Product, 2-Step Retinol-Rejuvenation System Following 3 Months of Treatment in Subjects With Photodamage
January 2017 | Volume 16 | Issue 1 | Original Article | 23 | Copyright © January 2017
Suzanne Bruce MDa and Sylvia Barkovic BAb
aThe Center for Skin Research, Suzanne Bruce and Associates, Houston,TX bValeant Pharmaceuticals North America LLC, Irvine, CA
BACKGROUND: Photodamage to the skin occurs with exposure to sunlight (UVA or UVB) either intentionally or unintentionally, and can present in a variety of ways. It typically occurs on areas of chronic UV exposure, including the face, ears, and neck.METHODS: We evaluated the effects of a 3-product, 2-step retinol-rejuvenation system containing an exfoliating cleanser, a 0.5% retinol emollient cream, and SPF 30 moisturizing sunscreen used daily for 3 months on the appearance of mild-to-moderate facial photodamage in female subjects.RESULTS: Significant improvements in facial appearance could be observed as early as 2 weeks, with continued improvement over the duration of the study. There were no adverse events reported that were related to study product and reports of cutaneous tolerability issues were rare.CONCLUSIONS: A 3-product, 2-step retinol-rejuvenation system provides significant improvements in signs of photodamage and overall skin appearance, and is well-tolerated.J Drugs Dermatol. 2017;16(1):23-28.
Photodamage of the skin occurs as a consequence of cumulative exposure to solar or other sources of ultraviolet (UV) radiation. It is characterized by coarse and fine wrinkles, roughness, yellowness, laxity, uneven pigmentation, brown spots, and a leathery appearance.1-3 Topical treatment is an ideal for many patients, especially those suffering from mild-to-moderate photodamage, because of its simplicity of use and relatively low associated cost. Tretinoin has been considered the gold standard topical treatment for photodamage.4 The efficacy and safety of tretinoin for the treatment of photodamaged skin has been established by a number of randomized, placebo-controlled trials conducted in the past 20 years,5-15 and reviewed extensively.16-21 The main drawback of tretinoin, however, is the frequency of skin irritation which typically occurs during the rst month of treat- ment, especially in young, fair-skinned patients. It is also only available on prescription. A precursor of tretinoin, retinol has great potential to treat photodamage, and a long history of use as an antioxidant in cosmetic formulations. Retinol has been shown to penetrate the skin barrier,22 and to induce clinical and histological changes without signs of irritation.23 Published clinical studies on the benefits of retinol in skin aging or photoaging are fewer in number compared to tretinoin. Nevertheless, topically applied retinol has been shown to improve the appearance of photodamaged skin.14,24-27A comprehensive facial regimen containing retinol along with a basic skincare regimen of a cleanser, moisturizer, and sunscreen has not been formally studied. An easy-to-follow skin care system is available (Obagi 360TM system) that incorporates a 0.5% formulation of retinol into a comprehensive skin care regimen providing cleansing, exfoliation, and photo-protection. The facial regimen is comprised of a cleanser with exfoliating beads and cross-linked papain enzyme, a 0.5% retinol emollient cream, and a SPF 30 moisturizing, broad spectrum sunscreen. The objectives of our study were to evaluate the effects on antiaging and photodamage when this skin care is used daily for up to 3 months.
Open-label, clinical usage study. The IntegReview Institutional Review Board (IRB) in AustinTX approved the protocol, and the study was conducted according to the principles of the 2004 version of the Declaration of Helsinki. All subjects signed informed consent.
Subjects were eligible for study enrollment if they were healthy females aged 25 to 50 years with mild-to-moderate facial photodamage (score of 2-5 on the overall Facial Photodamage Scale, where 0=none and 6=severe), prone to non-inflammatory acne (in about 30% of cases), and a Fitzpatrick skin type of I to IV, see Table 1 for inclusion and exclusion criteria.