ISDIN

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HELP OFFER PEOPLE WITH SEBORRHOEIC DERMATITIS AN ENHANCED QUALITY OF LIFE

FACIAL GEL CREAM

Proven efficacy in seborrhoeic dermatitis: 1 Helps to reduce: Flaking Itching Redness Helps to regulate sebum Promotes a matte complexion

Works from the very first application: 2

81 % less scaling

61 % less itching

59 % less redness

ISDIN Nutradeica® possesses antifungal and anti-inflammatory properties in the treatment of seborrhoeic dermatitis, demonstrated with innovative ex vivo models. 3

ANTIFUNGAL PROPERTIES

Ex vivo model of SD in human skin explants

Skin explant (control group)

Skin explant colonised with Malassezia furfur

TREATMENT WITH

Ketoconazole 2 % Cream

FACIAL GEL-CREAM

92 % growth of M. furfur

76, 3 % growth of M. furfur

Nutradeica® Facial Gel Cream achieved a reduction in the growth of Malassezia furfur vs. ketoconazole 2 % cream

ANTI-INFLAMMATORY PROPERTIES

Evaluation of pro-infammatory cytokines (IL-8 and TNF- )

Control Colonisation of M. furfur

Nutradeica Petroleum Hydrocortisone 1 % Cream

Nutradeica® Facial Gel Cream demonstrated anti-inflammatory properties similar to hydrocortisone 1 % cream

FACIAL GEL CREAM

RESULTS: After 7 days: Improvement of all symptoms of SD (erythema, itching, scaling, irritation) After 14 days: Significant improvement of SD severity Clinically proven efficacy in patients with moderate-to-severe seborrhoeic dermatitis on the face and chest 4

D0 D7 D14

Erythema

Itch

Scaling

Irritation

D14

*SI=Dermatological evaluation by clinical score

*IGA= Investigator’s Global Assessment Score

D14

*VAS= Visual analog scale

Significantly reduces number of M. furfur and S. Epidermidis colonies after 7 and 14 days

Nutradeica® Facial Gel Cream Main Ingredients and Properties 5

Ingredient

Property Antifungal

Piroctone olamine

Stearyl glycyrrhetinate

Anti-inflammatory Sebo-regulating

Zinc pidolate

Acetamide MEA

Kerato-regulating, conditioning agent Antifungal Anti-inflammatory, soothing, helps attenuate inflammatory reactions in the skin

Biosaccharide gum-2

Pentylene glycol + butylene glycol

Anti-irritant, anti-itch, anti-histaminic

+ hydroxyphenyl propamidobenzoic acid Polymethyl methacrylate

Hydrator and moisturisation enhancer

Nutradeica® Facial Gel Cream helps to improve quality of life in people with mild seborrhoeic dermatitis 6

IMPROVEMENT OF THE QUALITY OF LIFE on a functional, emotional and symptomatic level, according to SKINDEX-29

D0 D28

Improvement in quality of life

Clinical evaluation of seborrhoeic dermatitis: an integrated management approach 7

Clinical Evaluation

APPLY ONCE-DAILY

APPLY TWICE-DAILY

Evaluate medicine treatment

Managing both the active phase as well as maintenance of seborrhoeic dermatitis by incorporating Nutradeica® Facial Gel Cream. It is intended to help decrease the use of medications with potential side effects, as well as to minimise and prevent outbreaks.

References: 1. Valderas-Martinez P, et al . Poster presented at SDPA Meeting, San Diego, CA, June 2017. 2. Clinical study for the evaluation of the efficacy of Nutradeica ® Gel Cream in the treatment of mild SD (33 patients), 2009. Data on file. 3. Granger, C., Balato, A., Goñi-de-Cerio, et al. (2019). Novel Non-Steroidal Facial Cream Demonstrates Antifungal and Anti-Inflammatory Properties in Ex Vivo Model for Seborrheic Dermatitis. Dermatology and therapy , 9(3), 571–578. https://doi.org/10.1007/s13555-019-0311-4. 4. Balato, A., Caiazzo, G., Di Caprio, R., et al. (2020). Exploring Anti-Fungal, Anti-Microbial and Anti-Inflammatory Properties of a Topical Non-Steroidal Barrier Cream in Face and Chest Seborrheic Dermatitis. Dermatology and therapy, 10(1), 87–98. https://doi.org/10.1007/s13555-019-00339-w 5. ISDIN Data on File. 6. Piquero-Casals J, et al. Seborrheic dermatitis and quality of life: Evaluation of a facial gel-cream formulated with Zinc PCA, Piroctone olamine, Dihydro avenanthramide and Es-tearylglycyretinate. Poster presented at 46th AEDV. Palma de Mallorca. 2018 7. Piquero-Casals J, et al. Topical Non-Pharmacological Treatment for Facial Seborrheic Dermatitis. Dermatol Ther (Heidelb). 2019;9(3):469–477. Distributed by: Glenmark Pharmaceuticals South Africa (Pty) Ltd, 2nd Floor, Building D, Stoneridge Office Park, 8 Greenstone Place, Greenstone, Edenvale, Gauteng, 1609. Tel: (011) 564 3900. www.glenmarkpharma.co.za

SIYAENZA

NEW

Nutr atopic PRO-AMP ®

Extended control for atopic skin

The problem: Atopic Dermatitis

Atopic Dermatitis is a skin condition with disruptive symptoms which leads to an inammatory cycle.

Atopic Dermatitis (AD) is triggered by:

• Alterations in the cutaneous barrier • Altered barrier function • Immune deficiency

• Increased transepidermal water loss (TEWL) Xerosis, Itching

• Greater permeability to pathogenic substances and allergens Inflammation

• Increased bacterial adhesion and proliferation (Staphylococcus aureus) Microbial infections

Solution Nutr atopic ® PRO-AMP

The Nutratopic ® Pro-AMP product range, is developed to relieve these symptoms, effectively breaking the cycle: 5

Double active protection

Restores the skin barrier, reinforcing the lipid mantle: Ceramides, Omega-6 Reinforces the skin’s immune system defense: Pro-AMP L-lsoleucine

• Deep hydration Glycerin • Relieves itching and prevents scratching Polidocanol • Reduces inflammation Niacinamide • Reduces risk of bacterial adhesion Rhamnosoft

Emollients

Ω-6

Nutratopic ®

NEW

Facial Nutr atopic PRO-AMP ®

Facial Cream

Active protection of the skin’s defence system

• Helps reinforce the skin’s innate immune defence system L-lsoleucine

6,7,8,9

• Optimal absorption, facilitating compliance DMS lamellar structure that mimics the skin (Derma Membrane Structure)

• Reduces risk of bacterial adhesion Rhamnosoft

Directions for use: Apply twice daily as adjuvant to control the symptoms and as maintenance during remission periods.

6,7

8,9

Facial Nutr atopic PRO-AMP ®

Clinical Evidence:

Child (3 month old infant) using only Nutratopic ® Pro-AMP Facial for 4 weeks

D28

Child (2 month old infant) using only Nutratopic ® Pro-AMP Facial for 4 weeks

D14

Results in 107 children 11

Nutratopic ® Pro-AMP facial cream reduces the ESS by 84 % vs a 50 % reduction with a standard emollient cream 11

Evolution of facial ESS

Nutratopic ® Pro-AMP Control Group

The Eczema Severity Score (ESS) measures severity of outbreaks according to erythema, thickness, itching and skin lichenification. Evaluation from 0 (none) to 3 (severe). Study characteristics n=107, average age 5-6 years old, Randomised, Multicentre, evaluator-blind.

-50 % -84

ES Score

NEW

Specific Areas Nutr atopic PRO-AMP ®

Emollient Cream Active protection of the skin’s defence system • Restores barrier function Ceramides, Omega-6, Glycerin • Helps reinforce the skin's innate immune defence system L-lsoleucine • Relieves itching Polidocanol • Reduces inflammation Niacinamide • Reduces risk of bacterial adhesion Rhamnosoft 5 5 5 10 6,7,8,9

Directions for use: Apply twice daily or as needed on specific areas as adjuvant to control the symptoms and as maintenance during remission periods.

Specic areas require daily maintenance and control

In damaged areas in atopic skin there is subclinical inflammation even during remission periods. Intense, daily and continuous care of these areas is necessary to prevent new outbreaks. Texture provides immediate comfort and deep hydration, reinforcing the lipid mantle.

NEW

Body Nutr atopic PRO-AMP ®

Emollient Bath Gel Soft hygiene and specific protection without itching

• Helps reinforce the skin's innate immune defence system L-lsoleucine • Relipidising 18 % emollient oils • Reduces risk of bacterial adhesion Rhamnosoft • Optimal pH maintenance 6.01 vs. 6.35 • Hygiene with a specific syndet reduces the severity of eczematous lesions and maintains hydration in patients with AD 6,7,8,9 10

Directions for use: Apply daily to damp skin in the bath or shower and rinse.

Emollient Lotion Deep hydration for larger areas of the skin

6,7,8,9

• Helps reinforce the skin's innate immune defence system L-lsoleucine • Restores barrier function Ceramide 3 and other emollients • Relieves itching Polidocanol • Reduces risk of bacterial adhesion Rhamnosoft 5 5 10

Directions for use: Apply daily on large areas of clean and dry skin.

Holistic approach Nutr atopic PRO-AMP ®

A specic product line for proactive care, during the AD cycle.

Facial Cream Nutr atopic PRO-AMP ®

Facial

Specific Areas

Emollient Cream Nutr atopic PRO-AMP

Emollient Bath Gel Nutr atopic PRO-AMP Emollient Lotion Nutr atopic PRO-AMP ® ®

Body

Outbreak

Remission

Time

References: 1. Elias PM, Schmuth M. Abnormal skin barrier in the eƟopathogenesis of atopic dermaƟƟs. Curr Opin Allergy Clin Imunol. 2009;9(5):437–446. 2. Berlein-König B, Schäfer T, HussMarp J, et al. Skin surface pH, stratum corneum hydraƟon, transepidermal water loss and skin roughness related to atopic eczema and skin dryness in… Acta Derm Venereol. 2000; 80(3):188–191. 3. Michael J. Cork, et al. Epidermal Barrier DysfuncƟon in Atopic DermaƟƟs. Journal of InvesƟgaƟve Dermatology (2009) 129, 1892–1908; 4. Leyden JJ, Marples RR, Kligman AM. Staphylococcus aureus in the lesions of atopic dermaƟƟs. Br J Dermatol. 1974;90(5):525–530. 5. Marseglia A, Licari A, AgosƟnis F, et al. Efficacy of a rhamnoso�, ceramides and Lisoleucine cream in atopic eczema of the face: a randomized controlled trial. Pediatr Allergy Immunol 2014: 00. 6. An essenƟal amino acid induces epithelial b-defensin expression Pascale Fehlbaum, Meena Rao, Michael Zaslo*, and G. Mark Anderson; PNAS November 7, 2000 vol. 97 no. 23 pag 12723±12728. 7. Rivas-SanƟago InducƟon of b-defensins by l-isoleucine as novel immunotherapy in experimental murine tuberculosis. Clinical and Experimental Immunology ; 2011; 164: 80–89. 8. Defensins: AnƟmicrobial PepƟdes of innate immunity Tomas Ganz. Nature Reviews, Immunology Vol. 3 September 2003 710-720. 9. Lai Y, Gallo RL (2009) AMPed up immunity: how anƟmicrobial pepƟdes have mulƟple roles in immune defense. Trends Immunol 30:131–41. 10. Rhamnoso�� HP InflammaƟon so�ening, polysaccharide, special dammage skin. Solabia studys, France, 2011. Assessment of Rhamnoso�� HP effect on the adhesion of bacteria to the skin; Assessment of the effect of Rhamnoso�� HP on the aƩenuaƟon of a skin inflammaƟon (Data on file). 11. Puviani M, AgosƟnis F, Milani M. Barrier repair therapy for facial atopic eczema with a non-steroidal emollient cream containing rhamnoso�, ceramides and iso-leucine. A six-case report series. Minerva Pediatr 2014;66 Distributor: Glenmark PharmaceuƟcals South Africa (Pty) Ltd, 34 Monte Carlo Crescent, Block A, First Floor, Kyalami Park, Midrand, 1684. T: (011) 564 3900 | F: (011) 564 3939 | www.glenmarkpharma.co.za | ISDINNTP 07/2020

Psorisdin® Control Shampoo

Helps to reduce scaling and itchy scalp conditions. Helps to reduce recurrence of symptoms.

Effective, tolerable and cosmetically favourable compared to Coal Tar Shampoo: 1 • Proven to reduce the itchiness and soreness associated with scalp psoriasis 1 • Comparable efficacy for control of erythema, scale reduction and infiltrating lesions 1 Compliant texture: A cosmetically outstanding shampoo Provides a hair conditioning effect for maximum comfort and ease of brushing How to use: Apply the product on wet hair and massage until foam forms Wait for a few minutes, then rinse well. Repeat 3 to 4 times per week

Psorisdin® Control Shampoo

Excellent cosmetic properties

Good smell Hair is easy to brush Leaves hair shiny Easy to rinse out Frizz-free hair Softer hair

9/10 Rated by

Psoriasis Sufferers*

* ISDIN internal user tests

Itchiness? Drastic reduction after just 4 weeks 2 Gradual reduction and relief of itchiness from the first application

Clinical efficacy, proven results. Endorsed by dermatologists. Tested on 27 consumers under dermatological supervision

Psorisdin® Control Shampoo

Scalp Psoriasis It is estimated that 50 % of patients that has dry scalp conditions, develop plaque-like lesions, often with flaky skin and redness which can lead to a negative impact on a person’s quality of life. Active Ingredients: Descaling and exfoliating: Glycolic Acid 3 %, Salicylic Acid 3 % Antiproliferative, keratolytic and anti-inflammatory : Icthyol Pale 1,5 % Antipruritic: Laureth-9 Moisturising and keratoregulator: Urea ISDIN® 5 %

Greater efficacy than 4 % coal tar shampoo to reduce itching and burning

Better cosmetic qualities than 4 % coal tar shampoo

- Scent - Combing ease - Hair softness - Shine

Equivalent efficacy to control erythema, flaking and infiltration.

1,9

1,8

1,7

1,5

1,6

0,7

0,5

0,3

0 Average Score (VAS 0-10) Itching

Burning

Flaking

Erythema

Coal tar 4 %

Psoridin ®

Comparative study with 4 % coal tar shampoo. 3,4 Results in only 8 weeks

Psorisdin® Control Shampoo

Clinical Evidence Eficacy of Psorisdin® shampoo in the treatment of scalp psoriasis: A video-dermoscopy evaluation prospective study in 70 patients. 2

A Single-centre, prospective, open study with 70 patients affected by moderate/ severe intensity scalp psoriasis. Evaluated clinical efficacy by videodermoscopy (VSCAPS/score) and tolerability (pruritus VAS) of Psorisdin® Shampoo used 3 times a week for 12 weeks with controls at baseline after 45 and 90 days. Evolution of VSCAPSI Percentage of patients reporting pruritus

The study demonstrated that Psorisdin® Shampoo is well-tolerated and effective in the control of flaking and itching and leads to a significant clinical reduction of psoriatic alterations on the scalp, as demonstrated by videodermoscopy.

Distributed by: Glenmark Pharmaceuticals South Africa (Pty) Ltd. First floor, Block A, 34 Monte Carlo Crescent, Kyalami Park, Midrand, 1684. Tel: (011) 564 3900. www.glenmarkpharma.co.za ISDINPCS31/07/2020 1. Sánchez Regaña M, Dilmé M, Mirada A, et al . Increased efficacy and acceptabiility of a non-coaltar shampoo for scalp psoriasis: better efficacy and acceptability. Poster . 67th AAD San Francisco 2009. 2. Alfredo Rossi MD et al . Efficacy of Iralfaris shampoo in the treatment of scalp psoriasis: A videodermoscopy evaluation prospective study in 70 patients. G ITAL DERMATOL VENEREOL 2012;147:1-2. 3. Sanchez Regaña M, Dilmé E, Mirada A, et al , Increased efficacy and acceptability of a non-coal tar shampoo for scapl psoriasis: better efficacy and acceptability. Abstract accepted in 67th Annual meeting of the American Academy of Dermatology and Venereology. ADD . (San Francisco 2009) 4. Sanchez Regaña M, Dilmé E, De la Cruz, G, et al. Treatment of scalp psoriasis with a non-coal tar shampoo: excellent cosmetic results with no loss of effectiveness. Presentado en 17 Congress of European Academy of Dermatology and Venereology, EADV . (Paris 1008).

Repairs and normalises dry skin

Other moisturising ingredients

Urea Isdin ® has multiple actions based on the concentration used.

It is fundamental to choose the most adequate concentration of Urea Isdin ® for effectively managing the symptoms associated with each pathology.

Moisturiser

Extensive calluses

Localised calluses

Anti-roughness Cream Hydrates and reduces roughness Restores smoothness to the skin

Hyperkeratotic and callused skin

Severe hyperkeratotic states of skin and nails

Reduces severe hyperkeratotic states of skin and nails

Microscopic view of the gellified aqueous molecules which are each surrounded by a lipid layer.

- Optimal texture - Effective penetration - Increased dermatological affinity - Improved stability of the active ingredient

localised callus growths

For local application

Especially indicated for feet, hands, knees and elbows

Main indications Extensive calluses Plantar keratoderma Adjuvant treatment of psoriatic skin conditions

Anti-roughness Cream

Helps to improve skin elasticity.

• keratinocyte differentiation • the skins barrier function • elastin and collagen expression • the cellular rejuvenation process

Psoriatic skin lesions Rough skin Mild hyperkerototic states Keratosis pilaris

Anti-roughness Cream

Repairing Lotion Plus

moisturising

Repairing Lotion Plus

randomised

REFERENCES

Grether-Beck S, et al.: Urea revisited: a well-known molecule with previously unrecognized gene regulatory properties. Int J Cosmet Sci. 2009;31(4):309. Grether-Beck S, et al.: Urea acts on the dermis via induction of collagen expression. Presented to 18th Congress of the European Academy of Dermatology and Venereology. Berlin. 2009. Piraccini BM, Starace M: Urea 40 % in a new vehicle (gel-oil) for nail and plantar diseases. Data on file.

Raab WP. Uses of urea is cosmetology. Cosmetics and Toliletries. 1990; 105: 97-103.

Elewski BE et al. The use of 40 % urea cream in the treatment of moccasin tinea pedis. Cutis. 2004; 73(5):355-7.7.

Kligman AM. Dermatologi uses of urea. Acta Derm Venerol 1957; 37(2): 155-159.

Martins JE et al. In vitro sensitivity of dermatophytes to urea. Clinics. 2006; 61(1): 9-14.

Gemma Marquez Balbas et al. Urea a altas concentraciones: empleo en dermatologfa. Piel. 2008; 23(4) Shemer A et al. Treatment of scalp seborrheic dermatitis and psoriasis with an ointment of 40 % urea and 1 % bifonazole. Int J Dermatol. 2000; 39(7): 532-4. 14th EADV London 2005. Clinical and bioengineering evaluation of the efficacy and safety of 30 % urea cream in the treatment of hyperqueratotic skin disorder. J. Molinerol, R. Ojedal, J.Coll2, A Mirada2,C. Trullas2, C. Pelejero2, M.Sanchez Reganal. 64TH AAD San Francisco 2006. Usefulness of 30 % urea cream in hyperkeratotic skin disorders. A clinical and biophysical evaluation. M.Sanchez Reganal. R. Ojedal, J. Molinerol, J.Coll2, A Mirada2,C. Trullas2, C. Pelejero2. Pellacani et al. Dermatite da contatto: effetti cutanei indotti da applicazione di una crema a base di urea. HighTecDermo Journal (pending to publish HighTecDermo Journal). Tadini G, et al. Efficacy of topical 10 %. urea-based lotion in patients with ichthyosis vulgaris: a two-center, randomized, controlled, single-blind, right-vs.-left study in comparison with standard glycerol-based emollient cream. Current Medical Research & Opinion. 2011; 27(12):1-6. Castello M, Milani M: Efficacy of topical hydrating and emollient lotion containing 10 % Urea ISDIN plus dexpanthenol (Ureadin Rx 10) in the treatment of skin xerosis and pruritus in hemodialyzed patients: An open prospective pilot trial. Giornale italiano di Dermatologia. 5, 2011. In press. ® ® D'Agostino R, Coll J:Urea +Panthenol project. Data on file.

FOOT CARE

Gel Oil Repairs and Hydrates Dry and Cracked Feet

Eliminates roughness, hard skin and moderate thickening.

One of the most important, complex and delicate parts of the human body Due the strain of our body weight and our daily lifestyle, feet are constantly exposed to:

• Stress and external aggressions. • Lack of ventilation. • Changes in temperature. • Chafing and accidental bumps.

All of this can lead to very common alterations on the soles of the feet and heels:

• Dry and rough skin. • Thickened skin and calluses. • Yellow colour. • Flaking. • Cracks due to dryness. • Hyperkeratosis (calluses). • Mycosis (fungi).

Gel Oil Repairs and Hydrates Dry and Cracked Feet With Urea Isdin ® 10 %

Repairs cracks due to dryness: Thanks to re-epithelialising ingredients (Allantoin, Panthenol) and emollients (Shea Butter). 1

Eliminates roughness, hard skin and moderate thickening: Due to the exfoliating action of Lactic Acid and Bacillus ferment.

Hydrates intensely for 24h: Urea Isdin ® retains water, providing an optimal level of hydration. 2

Gel Oil Texture: Fresh, light, non-greasy texture with rapid absorption that facilitates daily use and maximises product efficacy.

Main Indications: • Cracks. Flaking. •

Calluses. • Dryness. •

1,3,4,5

Well-tolerated in 100 % of cases.

63 % * Decrease in crack depth. 1

97 % * Improvement in foot condition.

100 % ** Pleasant texture. 1

* Percentage of participants that showed improvements. ** Percentage of participants with a positive response.

Urea Isdin • An active molecule that penetrates the skin’s layers, stimulating physiological regeneration mechanisms. • Moisturising and exfoliating effects. • Stimulates formation of the skin barrier, reinforcing the skin’s immune system. • Promotes collagen synthesis. ®

Wash your feet once a day, with antiseptic acidic soap (pH 5.5) and warm water. • Dry them carefully, especially between the toes. • Keep foot skin well moisturised. Heels are the area of the feet which need the most hydration. • To avoid cracks due to dryness, apply a moisturising product with Urea, adapted to the condition of your feet. Trim your toenails straight and not too short. It is advisable to file them. • See a specialist if you have any pain, redness, itching between your toes, flaking, etc. • Basic foot care recommendations

Using a moisturising product with Urea Isdin promotes adequate foot hydration and prevents appearance of roughness, thickening or cracks. ®

References: 1. Dermscan study. EvaluaƟon on subjects, of the repairing effect of a cosmeƟc product on cracked heels. Report #08E5336, October 31, 2008. 2. PRC Study. EvaluaƟon, on subjects, of the 24 hours moisturizing effect of Ureadin® Podos a�er a single applicaƟon. Report 1441-079.08. Data on file. 3. PRC Study. Test consumidor Ureadin® Podos Reparador Talones y Pies Isdin R1441.031.01 vs. Producto N pies secos y estropeados. Report 2664-08. Data on file. 4. PRC Study. Test consumidor Ureadin® Podos Reparador Talones y Pies Isdin R1441.027.01 vs. Producto S talones agrietados. Report 2663-08. Data on file. 5. Zalacaín, A. Estudio piloto para valorar la eficacia y tolerabilidad de una crema con urea específica para la hiperqueratosis del talón. Data on file. Distributed by: Glenmark PharmaceuƟcals South Africa (Pty) Ltd. First floor, Block A, 34 Monte Carlo Crescent, Kyalami Park, Midrand, 1684. Tel: (011) 564 3900. www.glenmarkpharma.co.za | ISDINPOD07/2020

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