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Epionce.euEpisciences, Inc. Clinical Study
Epionce Lytic Lotion and Lite Lytic Lotion Visibly Reduce Actinic and Senile Comedones Abstract
Actinic and senile comedones occur in individuals exposed primarily Actinic and senile comedones (ASC) and Favre-Racouchot (FR) to extreme weather. In a 16-week blind, prospective, controlled clini- syndrome both result from the loss of dermal connective tissue, cal study, Epionce® Lytic and Lite Lytic Lotions eliminated 56.2% particularly elastin with diskeratinization of the pilosebaceous fol- of the visible comedones and reduced the severity by 53.6%, both licle resulting in sebum retention.3 These abnormalities result from highly statistically significant (p=0.0001). Similar significant changes prolonged exposure to radiation, both ultraviolet and x-ray, as well were also observed at 8 weeks. No panelists developed irritant reac- as other physical climate agents on predisposed skin.4 These lesions tions or symptoms with the test products.
have been observed in people as young as their late twenties with extensive exposure to the environment.5 Treatment for ASC and FR Introduction
with traditional acne peeling is generally disappointing due to the depth and large size of the comedones.6 Dermabrasion, extraction, A clinical characteristic of extrinsic aging, which is often a challenge curettage and excision, topical tretinoin and oral isotretinoin have all to treat, is actinic/senile comedones (ASC). These comedones may been reported to have variable success. A combined approach with progress to follicular cysts and yellowish nodules usually distrib- excision, dermabrasion and topical tretinoin appears to produce the uted on the lateral and inferior aspects of the periorbital area. The constellation of nodules, cysts and comedones is known as Favre Racouchot (FR) disease. It is reported to afflict 6% of people 50 years Unfortunately, a major limiting factor for therapeutic success is the and older, predominately Caucasians with outdoor lifestyles and/or difficulty of minimizing tissue destruction in the atrophic skin, which occupations.1 Other than destructive procedures such as curettage, results is slower healing time and less desirable cosmetic appearance. acne surgery and excision, topical tretinoin and systemic isotretinoin Poor patient compliance with the topical retinoids is another limit- are the only medications reported to effectively treat FR and ASC.2 ing factor since the afflicted, more mature population suffers from a Yet these two treatments are limited by adverse reactions especially in higher incidence of irritant reactions and/or symptoms after applica- tion. Retinoid irritation approaches 30% in sensitive skin people.8 Dermatologists can expect similar irritation rates in atrophic and A blinded, prospective controlled clinical study was performed to elderly skin. Moreover, there is a paucity of topical therapies with assess effectiveness of two cosmeceutical products in visibly reduc- documented effectiveness for ASC and FR despite these conditions ing the number and severity of ASC in 20 panelists. These botanical afflicting a significant number of people.
based products have keratolytic activity and prevent the release and activation of proinflammatory factors. The extracts are formulated in The test regimen consists of two novel cosmeceutical lotions distrib- an emollient base that contains delivery systems to maximize efficacy uted by Episciences, Inc. These products consist of blends of novel and minimize the risk of adverse reactions.
botanical extracts, including lipids and keratolytics combined with a naturally derived modified salicylate, in an emollient base that pre- Patients
vents release and activation of proinflammatory factors. The unique Twenty Caucasian panelists ages 62-85 signed an informed consent delivery systems in these products enhance delivery and maximize document. All panelists were Fitzpatrick photo skin types I-III. activity while reducing the risk of irritation. Individuals with adult acne and rosacea were excluded. Treatment consisted of a morning application of Epionce Lite Lytic Lotion These statistically significant trial results suggest these botanical and an evening application of Epionce Lytic Lotion, for a period of extracts may have previously unreported phytoestrogenic or antian- 16 weeks. No sunscreens or moisturizers were allowed during the drogenic activity. These botanical based products do not include teas, treatment period. In addition, no systemic retinoids, antiandrogens, soy, vitamins, retinoids, alpha hydroxy acids and traditional anti- estrogens, phytoestrogens or prolonged use of antibiotics were oxidants. Epionce cosmeceuticals are formulated for elderly, infant, atopic and sensitive skin, people with outdoor lifestyles and occupa-tions and those who live in harsh environments and climates. All 20 patients tolerated these proprietary products without visible irritation Method
or symptoms of itching, burning or sensitivity.
Board certified dermatologist investigators assessed the number andseverity of facial open and closed comedones. Assessments were The Epionce Lite Lytic and Lytic Lotions appear to be a significant made at 0, 8 and 16 weeks. The clinical severity of the lesions were advancement in apparently relieving people of a cutaneous nuisance.
graded using a scale where 0 = none and 10 = severe. The mean The technologies in Epionce products are pending U.S. patents.
value of severity of the lesions were graded using a scale where 0 = none and 10 = severe. The mean value of severity of the lesions and the number of lesions were statistically compared to baseline using a paired t-test with significance level of p<0.05. After cleansing the face with a non-medicated cleanser, a dime-sized amount of the test material was applied over the entire face, avoiding the upper eyelid.
Visible actinic comedones resolved by 56.6% and severity of the le-sions was reduced by 53.6% after 16 weeks of the test regimen. Both results are highly statistically significant with p=0.0001. The results at 8 weeks were similar statistically, but with lower raw scores, as exemplified in Table 1.
Epionce Lytic Lotion and Lite Lytic Lotion Visibly Reduce Actinic and Senile Comedones (cont.) References
1. Friedman SJ, Su WPD. Favre Racouchet syndrome associated with radiation therapy. Cutis. 1983; 31:306-10.
2. Jansen T, Plewig G. Favre Racouchot disease In: Demis DJ (ed) Clinical Dermatology. Philadelphia: Lippincott-Raven. 1997; (1) 4-44: 1-4.
3. Izumi AK, Marples RR, Klingman AM. Senile solar comedones. J Invest Dermatol. 1973; 61: 46-50.
4. Schultz Larsen F, Heydenreich G, Christiansen JV. Comedone formation following cobalt irradiation. Dermatologica. 1979; 158: 287-92.
5. Cuce LC, Paschoal LHC, Curban GV. Cutaneous modular elastoidosis with cysts and comedones: cases in women. Arch Dermatol. 1964; 89:798-862.
6. Ogawa CM, Degenerative skin disorders. Toll of age and sun. Geriatrics.
1975; 30: 65-9.
7. Sharkey MJ, Keller RA, Grabski WJ, et al. Favre-Rocouchot Syndrome: A combined therapeutic approach. Arch Dermatol. 1992; 128: 615-6.
8. Leyden JJ, Grove GL. Randomized facial tolerability studies comparing gel formula tions of retinoids used to treat acne vulgaris. Cutis. 2001; 67 (6 supp): 17-27.
Table 1 - Values for Clinical Grading and Lesion Counts Baseline
Patient’s Name: ___________________________________________________ Date of Birth / / Today’s Date / /________ Have you been diagnosed and/or treated for any of these conditions? (Please Check All That Apply) Asthma _______Irregular Heart Beat (arrhythmia) _______Kidney Disease requiring Dialysis ______Inflammatory Bowel Disease ( Crohn’s Disease or Ulcerativ