LS 9 0 8 8
SEBOREGULATOR
Division de Cognis France
DEFINITION / COMPOSITION
SKIN BENEFITS
SEBARYL® FL LS 9088 is a complex of biotechnological and synthetic origin, for oily skin and scalp with a seborrheic tendency.
1. Regulator of sebaceous secretion and excretion. 2. Cleansing, natural astringent and matifying effect on skin and scalp. 3. Improving the structure and the comfort of oily skin. 4. Improving the structure of oily hair; giving strength and balance. 5. Anti-irritating effect.
Sebaceous excretion
Epidermis
Infra-infundibulum Sebum
© P. CROLLA
Sebaceous glands
Secretion of sebum Pool of differentiated cells
B
SG
Germinative layer
COSMETIC USE
Undifferentiated cells
Medium dermis
Fig. 1 – Sebaceous glands, the target of SEBARYL® FL LS 9088: schema / microphotograph (SG = Sebaceous Gland).
Main components: 1. Amino acids and sulfurated peptides (seboregulation). 2. Vitamins B: niacinamide, biotin, panthenol (inhibition of lipogenesis). 3. Xanthic base: caffeine (inhibition of lipogenesis). 4. Steroidic heterosides of botanical origin (anti-inflammatory and auto-emulsifier of sebaceous lipids in excess). 5. Zinc salt (seboregulation). MECHANISM OF ACTION • The activity of sebaceous glands is modulated by psychic, nervous, neurovegetative and hereditary influences as well as related to lifestyle (worsening effect with overly strong detergent). • Sebaceous secretion is mainly controlled by sexual androgens (Fig. 2) in both men and women: testosterone, dehydroepiandrosterone, androstanediols.
Skin care: - for oily or mixed skin type, having an acneic tendency, - for skin having a shiny, irritable aspect. Hair care: - for oily scalp, with a seborrheic tendency, - in case of seborrheic alopecia. ORIGINALIT Y SEBARYL® FL LS 9088 does not cause any reaction such as sebaceous hypersecretion or rebound effect. DOSAGE / SOLUBILIT Y / MODE OF INCORPORATION 1. Dose of use: 3 to 5%. 2. Solubility: soluble in water, soluble in diluted ethanol, insoluble in oils. 3. Mode of incorporation: SEBARYL® FL LS 9088 is incorporated below 50°C during processing or at room temperature for cold processing. ANALY TICAL CHARACTERISTICS 1. Aspect: limpid pale yellow aqueous liquid with a weak odor. 2. Specifications: upon request.
FOR
TOLERANCE Good. © Doris Fanta
Fig. 2 – Mode of action of testosterone on a sebaceous cell.
These androgens become active at the level of sebaceous glands and hair follicles under the influence of enzymes; thus, testosterone, as soon as it enters into sebaceous cells, is transformed into dihydrotestosterone by a specific enzyme: 5α-reductase (demonstrated to be present in sebaceous glands). • The exaggeration of sebaceous secretion is linked to a higher sensitivity of the sebaceous gland to androgenic hormones. • Thanks to its constituents - lipotropic factors - SEBARYL® FL LS 9088 is a bioregulator of sebaceous secretion: - via decreased sebaceous lipogenesis, - via an anti-enzyme effect: inhibition of the 5α-reductase activity. Consequently, SEBARYL® FL LS 9088 is a regulator of sebaceous excretion.
9088-801-180
COSMETOLOGY
Acro-infundibulum
EFFICACY Test summaries overleaf. STORAGE In its original packaging, at 15 - 25°C. INCI NAME Water (and) Niacinamide (and) Yeast Extract (and) Aesculus Hippocastanum (Horse Chestnut) Seed Extract (and) Ammonium Glycyrrhizate (and) Panthenol (and) Propylene Glycol (and) Zinc Gluconate (and) Caffeine (and) Biotin. MANUFACTURER Laboratoires Sérobiologiques, division de Cognis France.
© LABORATOIRES SÉROBIOLOGIQUES, DIVISION DE COGNIS FRANCE
ACTIVE I NGREDIENT
A
SKIN / H AIR
SEBARYL® FL
SKIN / H AIR
E FF IC ACY TES TS SEBOREGULATING EFFECT (CLINICAL STUDY) Aim Comparison of the efficacy of a hydrogel containing 5% SEBARYL® FL LS 9088 for the treatment of oily skin having seborrheic and acneic tendencies, versus placebo. Protocol Double blind clinical study in 25 volunteers following the summarized experimental protocol. 25 healthy female volunteers seborrheic skin on the face
D0
hemi-face placebo
bidaily randomized treatment 4 weeks
hemi-face 5% SEBARYL ® FL LS 9088
Amount of active sebaceous glands Total amount of sebaceous spots detected on Sebutape - 4.2% (NS)
700 600
- 16.6% (*)
500 400 300 200 100 0
Placebo hydrogel
D0
Hydrogel with 5% SEBARYL FL LS 9088
Seborrheic flux Summarized surface of total sebaceous spots detected on Sebutape (mm2) 20 - 15.6% 18 - 21.6% (NS) (*) 16 14 12 10 8 6 4 2 0 Placebo hydrogel
D28
Hydrogel with 5% SEBARYL FL LS 9088 Statistics: Wilcoxon's T test (*) p = 0.05 (NS) not significant T SEM 25 subjects
D0: before treatment D28: after 4 weeks treatment
Fig. 4 – Anti-seborrheic activity of SEBARYL® FL LS 9088 quantified by image analysis on Sebutape. Evolution after a 4 week treatment of the amount of active sebaceous glands, and the quantity of excreted sebum. Mean results on 25 subjects. Placebo
D0
D28
D28 D0 + D28: Sebutape + image analysis (quantification of the anti-seborrheic activity)
ACTIVE I NGREDIENT
FOR
COSMETOLOGY
Fig. 3 – Schema of the experimental protocol.
Results (Fig. 4 and 5) Conclusion Only the hydrogel containing 5% SEBARYL® FL LS 9088 showed a significant anti-seborrheic activity with a decrease of the amount of active sebaceous glands, and of the seborrheic flux. The placebo hydrogel did not have such an activity. INHIBITION OF 5α-REDUCTASE (IN VITRO) Protocol The effect of SEBARYL® FL LS 9088 (1-10%) was evaluated on cultures of human fibroblasts containing 5α- reductase type I. The inhibition of 5α-reductase was evaluated by measuring testosterone (substrate of 5α-reductase) metabolized per µg DNA per hour. Results (Fig. 6) ANTI-SEBORRHEIC ACTIVITY ON SCALP (CLINICAL STUDY) Protocol
D0
5% SEBARYL® FL LS 9088
5 α -reductase activity in % / untreated 125 100 75
IC50 = 3.9%
50
IC50 = 2.4%
0
0
2
(*) (*)
Fig. 5 – Illustration of the anti-seborrheic activity of 5% SEBARYL® FL LS 9088 measured by image analysis on Sebutape, from one subject.
Conclusion SEBARYL® FL LS 9088 significantly inhibits 5α-reductase type I starting at a 5% dosage; this effect increases with the duration of the treatment. IC50 = 2.4% at 120 minutes.
4 6 8 10 SEBARYL FL LS 9088 in %
120 minutes
60 minutes
Statistics: Average ± SEM (*) very significant interval (p < 0.001) with the control (Student's t test)
Fig. 6 – Inhibition of 5α-reductase type I in human fibroblasts by SEBARYL® FL LS 9088.
Results Sebum level (µg/cm2) 350 - 20.7% (NS)
250
- 31.7% (*)
200 150
Conclusion A hair lotion containing 3% SEBARYL® FL LS 9088 showed a significant antiseborrheic activity on the scalp after a 4 week treatment. In the same experimental conditions, the placebo did not have such an effect.
100 50 0
Placebo lotion
D0 D28
D28: after 4 weeks of treatment Same measurement as on D0 Measurement areas
(*)
25
D28
Very clear decrease in the amount of sebaceous spots, being characteristic of an anti-seborrheic activity.
Many sebaceous spots of various sizes on the control lateral area.
300
10 healthy female or male volunteers hyperseborrheic scalp and hair D0: before treatment Lipometric measurement 2 hours after shampoo Randomization RIGHT LEFT Placebo lotion Lotion containing 3% SEBARYL® FL LS 9088
Decrease in the amount of small spots but persistence of a large seborrheic flux appearing through spots of large size.
Many sebaceous spots of various sizes.
Lotion containing 3% SEBARYL ® FL LS 9088 Statistics: Wilcoxon's T test (*) p = 0.0469 (NS) not significant T SEM
Fig. 8 – Evolution of the normal seborrheic level of the scalp, measured 2 hours after shampoo, after 4 weeks of treatment. Mean results from 10 subjects.
Fig. 7 – Schema of the experimental protocol. LABORATOIRES SÉROBIOLOGIQUES, DIVISION 9088-801-180
DE
COGNIS FRANCE - 3, RUE
DE
SEICHAMPS - BP40 - 54425 PULNOY (FRANCE) - FAX. (33) 3.83.29.98.65 - TEL. (33) 3.83.29.97.92 © LABORATOIRES SÉROBIOLOGIQUES, DIVISION DE COGNIS FRANCE
