The breakthrough medical product for the management of stretch marks

Class I Medical Device, FDA Listed

www.stratamark.net

SK-U

S-02

0-1-

0219

The breakthrough medical product for the management of stretch marks

• Softens and flattens raised and depressed stretch marks

• Reduces redness and discoloration of stretch marks

• Relieves itching and discomfort of stretch marks

• Suitable for pregnant women, breastfeeding mothers,children and people with sensitive skin

Stratamark is clinically proven to manage stretch marks

Stratamark group

Control group

Prevention studies Treatment studies

60–70%

18.2%

81.8%did not develop stretch marks10

Stratamed and Strataderm help mothers to get the best possible scar outcome after a caesarean section.

us.stratamed.comStratamed promotes faster wound healing and prevents abnormal scarring.

During wound healing

• Promotes faster wound healing by creatinga moist wound healing environment

• Suitable for breastfeeding mothers

us.strataderm.comStrataderm – for the professional treatment of scars both old and new.

After wound healing (suture removal)

• For effective management of abnormal andexcessive scar formation

• Suitable for breastfeeding mothers

80% of women demonstrateda significant level of improvement in

their stretch marks

87%of patients ratedthe feeling on the skin to bevery good - excellent

91%of patients ratedthe ease of useof Stratamarkvery good - excellent

90%of patients ratedthe efficacy of useof Stratamarkvery good - excellent

66%of patients in thetreatment groupreduced the severityof their existingstretch marksonly using Stratamark(=monotherapy)

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Manufactured by: Stratpharma AG, Aeschenvorstadt 57, C H-4051 Basel, Switzerland

US Sales Office: Stratpharma Inc., 7676 Hazard Center Dr, Suite 880, San Diego, CA 92108, USA 619.930.5788

• Over 500 pregnant women have participated in clinical studies with Stratamark.10,11

• Stratamark is suitable for pregnant women, breastfeeding mothers, children and people withsensitive skin.10,11

80%

60%

40%

20%

0 %

Control group

Incidence of Striae

p < 0.001

Stratamark as monotherapy

-43%

61 %

18.2 %

References: 1. Viennet C, Bride J, Armbruster V et al. Contractile forces generated by striae distensae fibroblasts embedded in collagen lattices. Arch Dermatol Res. 2005;297(1):10-17. doi:10.1007/s00403-005-0557-9. 2. Rotsztejn H et al. Advances in Medical Sciences 2010; 55 Rotsztejn H, Juchniewicz B, Nadolski M, Wendorff J, Kamer B. The unusually large striae distensae all over the body. Adv Med Sci. 2010;55(2):343-345. doi:10.2478/v10039-010-0011-x. 3. Chang A, Agredano Y, Kimball A. Risk factors associated with striae gravidarum. J Am Acad Dermatol. 2004;51(6):881-885. doi:10.1016/j.jaad.2004.05.030. 4. Lee KS et al. Clin Exp Dermatol 1994; 19(4):285–288. 4. LEE K, RHO Y, JANG S, SUH M, SONG J. Decreased expression of collagen and fibronectin genes in striae distensae tissue. Clin Exp Dermatol. 1994;19(4):285-288. doi:10.1111/j.1365-2230.1994.tb01196.x. 5. Klehr N. Striae cutis atrophicae. Morphokinetic examinations in vitro. Acta dermato-venereologica. Supplementum. 1979;59(85):105-8. 6. Tsuji T, Sawabe M. Elastic fibers in striae distensae. J Cutan Pathol. 1988;15(4):215-222. doi:10.1111/j.1600-0560.1988.tb00547.x. 7. Osman H, Usta IM, Rubeiz N, Abu-Rustum R, Charara I, Nassar AH. Cocoa butter lotion for prevention of Striae Gravidarum: a double-blind, randomised and placebo-controlled trial. BJOG 2008; 115: 1138-1142 8. Bernstein E. What Causes Stretch Marks? December 2008. The Patient’s Guide to Stretch Marks. 9. Al-Himdani S, Ud-Din S, Gilmore S, Bayat A. Striae distensae: a comprehensive review and evidence-based evaluation of prophylaxis and treatment. British Journal of Dermatology. 2014;170(3):527-547. doi:10.1111/bjd.12681. 10. Malkova S. The Effect of Innovative Gel in the Prevention and Treatment of Striae (Stratamark Gel). NEUMM. 2014;1–4/4: 1-7. 11. CD Hughes, A Hedges, The use of an innovative film-forming gel in preventing Striae Gravidarum and treating Striae Distensae, Australasian Journal of Dermatology, 2018.Caution: For external use only. Always read the label. Use only as directed. Keep out of reach of children. For further instructions please refer to the Patient Information Leaflet (PIL).

Striae Distensae are a form of pathological scarring

Striae Rubrae: fine elastic fibres predominate in the dermis with thicker fibres in the periphery; there is a reduction and reorganization of elastin and fibrillin fibres and structural changes in collagen are seen.

Striae Rubrae

Reticular dermis

Normal skin: randomly arranged small collagen and thin elastin fibres in the papillary dermis, coarse elastic fibres and thick bundles of collagen parallel to the direction on the skin in the reticular dermis.

Normal skin

Epidermis

Papillary dermis

Histological comparison of normal skin, Striae Rubrae and Striae Albae9

Striae Albae: histology demonstrates epidermal atrophy and loss of the rete ridges; densely packed, thin eosinophilic collagen bundles are arranged horizontally, parallel to the surface of the skin in a similar way to a scar.

Striae Albae

Elastin Collagen

Distribution of gestational ages when Striae fi rst appear

Hormonal changes are one of the main risk factors for the development of stetch marks.8

Symptomatic relief

Stratamark relieves the itching and discomfort of stretch marks.

Film-forming, flexible, full contact

Stratamark is a flexible, full-contact dressing that forms a thin film and ensures constant contact with the skin.

Light adherence

Lightly bonds to the most superficial layer of the skin.

Medical device

Stratamark is a Class I European, TGA (Therapeutic Goods Administration) registered and FDA listed medical device.

Non-reactive

Stratamark is non-reactive. It is suitable for pregnant women, breastfeeding mothers, children and people with sensitive skin as it does not contain alcohol, fragrances or parabens.

Softens and flattens

Stratamark softens and flattens raised and depressed stretch marks.

Reduces redness and discoloration

Stratamark reduces redness and discoloration of stretch marks.

Mode of action

Hydration

Stratamark is semi-occlusive and gas perme-able, which allows the skin to breathe and remain hydrated.

Modulation

Stratamark influences the epidermal-dermal signaling cascade via a regulation role of the epidermis on fibroblast production. Keratino-cytes have shown to activate the fibroblasts, hence collagen and glycosaminoglycan production. This leads to the normalizing of the keratinocyte hydration status and the normalizing of tissue growth factors, which signals dermal fibroblasts to normalize the collagen synthesis cycle of stretch marks.˙ˇ

Protection

Stratamark protects the skin from irritants and microbial invasion while reducing the risk for contact dermatitis.

• One 20g tube contains enough gel forapproximately one month of treatmentin the late stages of pregnancy.

• One 50g tube contains enough gel forapproximately two months of treatmentin the late stages of pregnancy.

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Striae are a pathological condition of the connective tissue.1 The pathogeneses are changes in the extracellular matrix, especially in collagen, elastin and fibrillin.2–5

Histologically, Striae are atrophic scars. The collagen ruptures and the gap is filled with newly synthesized collagen, which aligns in accordance with the local stress forces.6

Although Striae are not detrimental to health, they can cause physical symptoms such as itchiness, tenderness and pain.7 Because of their visibility, they can also significantly affect a woman’s self-esteem and image.7

Management of stretch marks during pregnancy:

Stratamark is recommended for use from the beginning of the second trimester (13 weeks) or at the first sign of stretch marks. Treatment should be continued following birth for a minimum of 60 to 90 days.

Treatment of existing stretch marks:

Stratamark should be used for at least 60 to 90 days (24 hours a day/ 7 days a week). Contin-ued use is recommended until no further improvement is seen. Severe and/or older stretch marks may need longer treatment. Stratamark may also be used in combination with other stretch mark treatments including laser therapy (non-ablative lasers, PDL, IPL, Radio Frequency devices).

When the use of Stratamark is initiated in the 13th week of pregnancy, approximately 3 50g tubes are required for a full treatment including 60–90 days post partum, when used on breast, thighs and abdomen.