The Intense Mederma Patch is classified as a medical device. The intended use of the Mederma Patch is for:

  • Prevention of the formation of raised and discolored scars
  • To flatten, fade and smooth older scars (hypertrophic and keloid scars)
  • Protection of the sensitive scar area
  • Helps alleviate the itching, burning and feeling of tension that often accompany the scarring process

The Mederma Patch is intended to be applied on fresh and all other scars including hypertrophic and keloid scars optimally for a minimum of 6 hours or overnight. Duration of use is intended to be at least 3 months. The patch contains additional ingredients with skin care properties to improve scar smoothness and softness. The patch is intended for contact with intact skin, and it is not reusable. It is a non-invasive, non-active and short term class I medical device.

Evidence suggests that the primary mode of action is occlusion; additional ingredients have hydrative, moisturizing functions. Occlusion is deemed an air- and water-tight dressing for application on the skin. The Mederma Patch’s soft MicroAir cushion is specially designed to reduce the transepidermal water loss for a balanced, moisture-retaining atmosphere inside the skin and provide protection of sensitive tissue.

Cepalin and Allantoin are hydrating and moisturizing ingredients that are gradually released by the patch. Cepalin and Allantoin are embedded in the adhesive layer of the Active-Release-Matrix and are released into the skin after the patch is applied. This Double Mode of Action (occlusion and release of hydrating ingredients) helps to regulate the scar formation process preventing excessive scarring and making the scar tissue softer, smoother and more elastic.

The patch can be applied to flatten, fade and smooth existing scars, including hypertrophic scars and keloids.

Product Details

  • 21 patches (12 cm x 3 cm) per box
  • The hypoallergenic patch is soft, thin and flexible and suitable for all parts of the body.
  • The patch is self-adhesive and easily removable.
  • For best results treatment should be started as soon as the wound healing is completed or stitches are removed.
  • Use for 3 months on new scars and 6 months on old scars for best results.
  • Do not use on open wounds or mucosa
  • Each patch should be applied for a minimum of 6 hours overnight when the skin’s natural healing process is particularly active for optimal results.

Background Research

In 1981, a burn care team in Australia made the discovery that topical occlusive silicone dressings effectively reduce the severity of burn hypertrophic scars1 Within the next few years, further uncontrolled studies documented the successful use of occlusive dressings in the treatment of hypertrophic scars and keloids2-10. Subsequently, controlled trials provided more evidence for the effectiveness of such treatments11-27. Although most of the studies investigated occlusive patches that contain silicone, other materials have shown same effectiveness as long as they provide a semi- or fully occlusive environment beneath the dressing, establishing that silicone is not necessarily needed for the effect28-35.

In vivo and in vitro evidence suggests that possible mechanisms are hydration caused by occlusion of the underlying skin, increased oxygen tension, increased temperature, polarization of the scar tissue caused by negative static electric charge generated by movement of the dressing, and tensile reduction36. Through these mechanisms, a correction of aberrant immunologic processes in the scar tissue could be seen in histological studies.

References
  1. Perkins K, Davey RB, Wallis KA. Silicone gel: a new treatment for burn scars and contractures, Burns, 1982, 9, 201-204.
  2. Ahlering PA. Topical silastic gel sheeting for treating and controlling hypertrophic and keloid scars: case study. Dermatol Nurs. 1995 Oct;7(5):295-7, 322
  3. Chuangsuwanich A, Osathalert V, Muangsombut S. Self-adhesive silicone gel sheet: a treatment for hypertrophic scars and keloids. J Med Assoc Thai. 2000 Apr;83(4):439-44.
  4. Dockery GL, Nilson RZ. Treatment of hypertrophic and keloid scars with SILASTIC Gel Sheeting. J Foot Ankle Surg. 1994 Mar-Apr;33(2):110-9.
  5. Foo CW, Tristani-Firouzi P. Topical modalities for treatment and prevention of postsurgical hypertrophic scars. Facial Plast Surg Clin North Am. 2011 Aug;19(3):551-7. Review.
  6. Gold MH, Foster TD, Adair MA, Burlison K, Lewis T. Prevention of hypertrophic scars and keloids by the prophylactic use of topical silicone gel sheets following a surgical procedure in an office setting. Dermatol Surg. 2001 Jul;27(7):641-4.
  7. Hamanová H, Broz L. Topigel in the treatment of hypertrophic scars after burn injuries.Acta Chir Plast. 2002;44(1):18-22.
  8. Ohmori S. Effectiveness of silastic sheet coverage in the treatment of scar keloid (hypertrophic scar) Aesthetic Plast Surg. 1988 May;12(2):95-9.
  9. Quinn KJ, Evans JH, Courtney JM, Gaylor JD, Reid WH. Non-pressure treatment of hypertrophic scars. Burns Incl Therm Inj. 1985 Dec;12(2):102-8.
  10. Wong TW, Chiu HC, Chang CH, Lin LJ, Liu CC, Chen JS. Silicone cream occlusive dressing--a novel noninvasive regimen in the treatment of keloid. Dermatology. 1996;192(4):329-33.
  11. Ahn ST, Monafo WW, Mustoe TA. Topical silicone gel: a new treatment for hypertrophic scars. Surgery. 1989 Oct;106(4):781-6; discussion 786-7.
  12. Ahn ST, Monafo WW, Mustoe TA. Topical silicone gel for the prevention and treatment of hypertrophic scar. Arch Surg. 1991 Apr;126(4):499-504.
  13. Amicucci G, Schietroma M, Rossi M, Mazzotta C. Silicone occlusive sheeting vs silicone cushion for the treatment of hypertrophic and keloid scars: a prospective-randomized study. Ann Ital Chir 2005;76:79–83.
  14. Atkinson JA, McKenna KT, Barnett AG, McGrath DJ, Rudd M. A randomized, controlled trial to determine the efficacy of paper tape in preventing hypertrophic scar formation in surgical incisions that traverse langer’s skin tension lines. Plast Reconstr Surg 116;1648,2005
  15. Carney SA, Cason CG, Gowar JP, Stevenson JH, McNee J, Groves AR, Thomas SS, Hart NB, Auclair P. Cica-Care gel sheeting in the management of hypertrophic scarring. Burns. 1994 Apr;20(2):163-7.
  16. Cruz-Korchin NI. Effectiveness of silicone sheets in the prevention of hypertrophic breast scars. Ann Plast Surg. 1996 Oct;37(4):345-8
  17. de Oliveira GV, Nunes TA, Magna LA, et al. Silicone versus nonsilicone gel dressings: a controlled trial. Dermatol Surg 2001;27:721–6.
  18. Gold MH. A controlled clinical trial of topical silicone gel sheeting in the treatment of hypertrophic scars and keloids. J Am Acad Dermatol. 1994 Mar;30(3):506-7.
  19. Lee SM, Ngim CK, Chan YY, Ho MJ. A comparison of Sil-K and Epiderm in scar management. Burns. 1996 Sep;22(6):483-7
  20. Li-Tsang CW, Lau JC, Choi J, Chan CC, Jianan L. A prospective randomized clinical trial to investigate the effect of silicone gel sheeting (Cica-Care) on post-traumatic hypertrophic scar among the Chinese population. Burns. 2006 Sep;32(6):678-83. Epub 2006 Jul 11
  21. Maján JI. Evaluation of a self-adherent soft silicone dressing for the treatment of hypertrophic postoperative scars. J Wound Care. 2006 May;15(5):193-6.
  22. Niessen FB, Spauwen PH, Robinson PH, Fidler V, Kon M. The use of silicone occlusive sheeting (Sil-K) and silicone occlusive gel (Epiderm) in the prevention of hypertrophic scar formation. Plast Reconstr Surg. 1998 Nov;102(6):1962-72
  23. Sawada Y, Sone K. Hydration and occlusion treatment for hypertrophic scars and keloids. Br J Plast Surg. 1992 Nov-Dec;45(8):599-603.
  24. Sproat JE, Dalcin A, Weitauer N, Roberts RS. Hypertrophic sternal scars: silicone gel sheet versus Kenalog injection treatment. Plast Reconstr Surg. 1992 Dec;90(6):988-92.
  25. Tan E, Chua SH, Lim JT. Topical silicone gel sheet versus intralesional injections of triamcinolone acetonide in the treatment of keloids: a patient-controlled comparative clinical trial. J Dermatolog Treat 1999;10:251-4.
  26. Widgerow AD, Chait LA, Stals PJ, Stals R, Candy G. Multimodality scar management program. Aesthetic Plast Surg. 2009 Jul;33(4):533-43. Epub 2008 Dec 2.
  27. Wigger-Alberti W, Wilhelm D, Mrowietz U, Eichhorn K, Kuhlmann M, Ortega J, Bredehorst A, Wilhelm KP Efficacy of a Polyurethane Dressing on Hypertrophic Scars in Comparison to a Silicone Sheet. http://www.hansaplast.de/~/media/Hansaplast/international/ studies/wound-care/PosterHP_HypertrophicScars_01%20%282%29.pdf.
  28. Bieley HC, Berman B. Effects of a water-impermeable, nonsilicone-based occlusive dressing on keloids. J Am Acad Dermatol 1996;35:113–4
  29. de Oliveira GV, Nunes TA, Magna LA, et al. Silicone versus nonsilicone gel dressings: a controlled trial. Dermatol Surg 2001;27:721–6.
  30. Gallant-Behm CL, Mustoe TA. Occlusion regulates epidermal cytokine production and inhibits scar formation. Wound Repair Regen. 2010 Mar-Apr;18(2):235-44.
  31. Gilman TH. Silicone sheet for treatment and prevention of hypertrophic scar: a new proposal for the mechanism of efficacy. Wound Repair Regen. 2003 May-Jun;11(3):235-6.
  32. Kloeters O, Schierle C, Tandara A, Mustoe TA. The use of a semi-occlusive dressing reduces epidermal inflammatory cytokine expression and mitigates dermal proliferation and inflammation in a rat incisional model. Wound Repair Regen. 2008;16(4):568-575.
  33. Klopp R, Niemer W, Fraenkel M, von der Weth A. Effect of four treatment variants on the functional and cosmetic state of mature scars. J Wound Care. 2000 Jul;9(7):319-24.
  34. Niessen FB, Spauwen PH, Schalkwijk J, Kon M. On the nature of hypertrophic scars and keloids: a review. Plast Reconstr Surg. 1999 Oct;104(5):1435-58.
  35. Ricketts CH, Martin L, Faria DT, Saed GM, Fivenson DP. Cytokine mRNA changes during the treatment of hypertrophic scars with silicone and nonsilicone gel dressings. Dermatol Surg. 1996 Nov;22(11):955-9.
  36. Akaishi S, Akimoto M, Hyakusoku H, Ogawa R. The tensile reduction effects of silicone gel sheeting. Plast Reconstr Surg. 2010 Aug;126(2):109e-11e.

Directions

Mederma Patch Directions for Use
  1. Thoroughly wash and dry the scar area. Make sure the wound is completely closed and the skin is intact.
  2. Open the package and remove the Mederma® Patch.
  3. Peel off the transparent backing of the adhesive side of the patch.
  4. Avoid touching the adhesive surface before application.
  5. Apply the patch so that the scar is completely covered.
  6. For a smaller scar, the patch may be cut to size using clean scissors. Cut before peeling off the transparent backing.
  7. For larger scars, apply patches side by side
  8. Keep the patch in place for a minimum of 6 and a maximum of 12 hours; overnight might be the best choice for optimal results; when the regeneration process of the skin is particularly active.
  9. Remove the patch in the morning and discard; patch is not reusable
  10. For best results, apply a new patch daily for a minimum of 3 months

Warnings

  • Do not use on open wounds, or wounds with surgical sutures.
  • Do not use on or near mucosal tissue
  • Do not use on inflamed skin
  • Do not use if you are sensitive to Acrylate, Cepalin or Allantoin.
  • If persistent discomfort or irritation occurs, discontinue use and consult a dermatologist or any other physician.
  • Keep out of the reach of children
  • Do not use the patch after the expiry date
  • If the patch is cut to size, the unused part must be used within 14 days.
  • Do not use in children below the age of 3 years.
What is the Intense Mederma® Patch and its intended use?
The Mederma Patch is an innovative product with a dual mode of action offering an effective treatment for fresh scars after wound closure. The application of the patches for at least 3 months prevents the formation of raised and discoloured scars. The patch also occludes the sensitive scar area and through hydration helps to alleviate the itching, burning and feeling of tension which often accompanies the scarring process. The hypoallergenic patch is soft, thin and flexible and suitable for all parts of the body.
How does the Intense Mederma® Patch Work?

The two-layer composition of the Mederma® Patch offers a dual mode of action that helps occlude and hydrate during the scarring process. This helps in preventing the formation of excessive scars, while improving the smoothness, and softness of the newly formed tissue.

  1. Occlusion effect: The soft Micro-Air-Cushion Seal is specially designed to reduce the transepidermal water loss of the scar tissue to ensure that a balanced, moisture retaining atmosphere inside the affected skin is maintained. In addition, the soft foam material protects the sensitive scar tissue.
  2. Release of hydrating and moisturizing ingredients: In the Active-Release-Matrix in the adhesive layer, the well-known Mederma® substances Cepalin and Allantoin are embedded. As soon as the patch is applied to the skin, these substances are gradually released over several hours.
What is Cepalin® ?
Cepalin® is the proprietary botanical extract in all Mederma® products. It’s part of the Mederma® formula that works to improve the overall appearance, texture, and color of scars
How long do I need to use the Mederma® Patch?

Keep the patch in place for a minimum of 6 and a maximum of 12 hours; overnight might be the best choice for optimal results; when the regeneration process of the skin is particularly active. Remove the patch in the morning and discard; patch is not reusable.

Use for 3 months on new scars and 6 months on old scars for best results.

My Mederma Patch carton says “do not use on open wounds or mucosa.” When is a wound considered closed?
A wound is completely closed when the scab falls off or the stitches are removed. You can begin to use Mederma® as soon as there is no visible scab where the wound occurred or your stitches have been removed. While there is still a scab or stitches present, keep the wound clean and covered
Where can I find the Mederma patch?
The Mederma Patch is available in the first aid aisle at most major retailers.
Does the Mederma patch make scars disappear?
No product can make scars disappear completely. But the Mederma® Patch can help them appear softer, smoother, and less noticeable.