Pilot Study of Topical Copper Chlorophyllin Complex in Subjects With Facial Acne and Large Pores
June 2015 | Volume 14 | Issue 6 | Original Article | 589 | Copyright © June 2015
Thomas J. Stephens PhD,a John P. McCook BS,b and James H. Herndon Jr. MDc
aThomas J. Stephens & Associates, Inc., Richardson, TX
bDiscovery Partners LLC, Frisco, TX
cDermatology Center of Dallas, Dallas, TX
BACKGROUND: Acne vulgaris is one of the most common skin diseases treated by dermatologists. Salts of copper chlorophyllin complex are semi-synthetic naturally-derived compounds with antioxidant, anti-inflammatory and wound healing activity that have not been previously tested topically in the treatment of acne-prone skin with enlarged pores.
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 subjects with mild-moderate acne and large, visible pores over a course of 3 weeks.
METHODS: Subjects were supplied with the test product, a topical gel containing a liposomal dispersion of sodium copper chlorophyllin complex (0.1%) with directions to apply a small amount to the facial area twice daily. Clinical assessments were performed at screening/baseline and at week 3. VISIA readings were taken and self-assessment questionnaires were conducted.
RESULTS: 10 subjects were enrolled and completed the 3-week study. All clinical efficacy parameters showed statistically significant improvements over baseline at week 3. 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 acne and large, visible pores when used for 3 weeks. J Drugs Dermatol
Acne vulgaris is one of the most common skin diseases treated by dermatologists. This chronic disease is estimated
to affect 40 to 50 million people in the U.S.1 Acne is also considered the most frequent dermatologic condition
in patients with skin of color.2 The pilosebaceous unit is recognized as the target organ in acne with pathophysiologic factors of the disease including increased sebum production, inflammation, impaired keratinization and colonization by the gram-positive anaerobe, Propionibacterium acnes.3, 4 Topical administration is the most common means of delivering anti-acne medications and such treatments include retinoids, benzoyl
peroxide, antibiotics and various combinations.5, 6 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. From a dermatology perspective, its antioxidant,
anti-inflammatory and wound healing properties are of potential interest.7-10 The objective of this pilot study is to assess the effect of a liposomal dispersion of topical sodium copper chlorophyllin complex in the treatment of mild-moderate
acne with large, visible pores.
MATERIALS AND METHODS
10 subjects (aged 18-30) with Fitzpatrick skin type I-IV in good general health were entered into study. Subjects were required to have a score of 1 to 3 (mild-moderate acne) based on the Global Acne Assessment scale (modification of the Cook Acne scale 11) along with large, visible pores on the nose and/or cheeks with self-perceived oily facial skin and visible skin blotchiness.
Prior to treatment, subjects provided written informed consent conforming to 21 CFR50.25. Subjects were given the test product, a topical gel containing a liposomal dispersion of sodium copper chlorophyllin complex, 0.1% (Phytochromatic®CHLcu, chlorophyllin
liposomal concentrate complex, 2%) and instructed to apply a dime-sized amount to the facial areas each morning and evening after cleansing the skin. Subjects were provided with detailed verbal
and written instructions for use, a calendar for study visits and a diary to record application times and comments.
The study was conducted in Dallas, Texas from October to November 2005.
Subjects were treated over a 3-week period with visits at screening/baseline, and week 3. Subjects arrived at the clinic