Assessment of the Safety and Efficacy of Topical Copper Chlorophyllin in Women With Photodamaged Facial Skin
April 2015 | Volume 14 | Issue 4 | Original Article | 401 | Copyright © 2015
Monya L. Sigler PhD, and Thomas J. Stephens PhD
Thomas J. Stephens & Associates, Inc., Richardson, TX
BACKGROUND: Chronic exposure to the sun causes the skin to prematurely age. Photodamaged skin is characterized by progressive
damage to the dermal extracellular matrix with loss of collagen and degradation of elastin. Clinical manifestations of such photoaged
or photodamaged skin include wrinkles and irregular pigmentation. Various cosmetic treatments including topical retinoids, growth
factors, and skin lighteners have shown some benefit. Salts of copper chlorophyllin complex are semi-synthetic naturally derived compounds
with anti-oxidant and wound healing activity that has not been previously tested in photodamaged skin.
OBJECTIVES: This single-center pilot study was conducted to assess the efficacy and safety of a liposomal dispersion of topically applied sodium copper chlorophyllin complex in women with mild-moderate fine lines and wrinkles in the periocular areas and facial solar lentigenes over a course of 8 weeks.
METHODS: Subjects were supplied with the test product, a topical gel containing chlorophyllin complex salts (0.066%), with directions to apply a pea-sized amount to the periocular areas, cheeks and nose every morning and evening. Clinical assessments were performed at screening/baseline and at week 8. Standardized digital photographs were taken and self-assessment questionnaires were conducted.
RESULTS: Ten subjects completed the 8-week study. All clinical efficacy parameters showed statistically significant improvements over baseline at week 8. The study product was well tolerated. Subject questionnaires showed the test product was highly rated.
CONCLUSIONS: In this pilot study, a topical formulation containing a liposomal dispersion of sodium copper chlorophyllin complex was shown to be clinically effective and well tolerated for the treatment of mild-moderate photodamage and solar lentigenes when used for 8 weeks.
J Drugs Dermatol. 2015;14(4):401-404.
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Chronic sun exposure causes photoaging of the skin. Exposure to UV radiation induces matrix metalloproteinases (MMPs), which degrade collagen and other components of the extracellular matrix (ECM). Increased MMPs resulting from chronic exposure to the sun can cause accumulation of dermal ECM fragments, which contribute to both aged skin appearance and impaired skin function.1, 2 This premature aging in the appearance and function of the skin is both cumulative over time and dependent on the degree and intensity of exposure to the sun.3, 4 Photoaged skin is characterized by various clinical manifestations including wrinkling, pigmentary changes, laxity, telangiectasia, solar lentigenes, coarseness and various benign, premalignant, and malignant neoplasms on areas of the body chronically exposed to the sun. Uneven pigmentation and solar lentigenes are prominent features in sun-exposed skin.5-7
The efficacy of topical retinoids in the treatment of photoaged skin, including dyspigmentation, is well known.8, 9 Likewise, in small trials, the use of certain anti-aging products containing growth factors has been shown effective in photoaging.10-12
Copper Chlorophyllin Complex, sodium salt (CHLcu) is a derivative of the natural green pigment, chlorophyll. CHLcu and chlorophyll have long been associated with various health benefits. Chlorophyllin-copper complex, sodium is an approved color additive by the FDA. Of interest to dermatology are its antioxidant, anti-inflammatory and wound healing properties.13-16 The objective of this study is to assess the effect of a liposomal dispersion of topical sodium copper chlorophyllin complex in the treatment of UV-induced photodamage.
MATERIALS AND METHODS
Ten female subjects (aged 40 years or older) with Fitzpatrick skin type I-IV in good general health with both mild-moderate facial photodamage and 2-3 discreet solar lentigenes were entered into the study. An expert grader selected one side of the face (right or left) on each subject that showed the greater severity in photodamage for efficacy/performance grading, pinch recoil and photography.
Prior to treatment, subjects provided written informed consent conforming to 21 CFR50.25. Before starting the study, subjects were not allowed use of moisturizing products on the face for 3-5 days. Subjects were given the test product, a topical gel containing chlorophyllin complex salts 0.066% (Phytochromatic® chlorophyllin liposomal concentrate complex 1.32%) and instructed to apply a pea-sized amount to the periocular areas, cheeks and nose each morning and evening after cleansing the skin. Subjects were provided with written instructions for use, a calendar for study visits and a diary to record application times and comments.