Clinical evidence

The claims for Nourisil™ MD are listed below:

 

Claim

Justification of claim

Nourisil™ MD treats and prevents keloids and (hypertrophic) scars after the wound has healed and the skin surface is intact.Multiple RCTs have shown the efficacy of silicones in the treatment of and prevention of keloids and hypertrophic scars. See Bibliography listed below: (11), (12), (13),(14), (15), (16), (17), (18).
Nourisil™ MD is proven to flatten, soften and smooth scars, relive the itching, pain and discomfort of scars and reduce any associated redness.Multiple RCTs have shown that silicone gel is able to flatten, soften and smooth scars. Moreover, they have shown to relieve itching, reduce the pain, redness and discomfort caused by scars. See Bibliography listed below : (11), (12), (13), (14), (15), (16), (17), (18).
Nourisil™ MD helps to maintain the skin’s hydration  balance.The treatment with silicone gel provides occlusion and by this mechanism decreases the evaporation of water from the skin and increases     the hydration of the stratum corneum. See Bibliography listed below: (4), (1), (3), (5).
Nourisil™ MD contains safe ingredients.Nourisil™ MD has a safe ingredient selection, based on literature references for ingredients safety. See Bibliography listed below: (12), (13), (19) (20), (21), (22), (23), (24), (25).
Nourisil™ MD can be used for all patients, including children.Case reports have reported safe use in children. Moreover, it has been advised in several pediatric  hospital guidelines. See Bibliography listed below: (26), (27), (5), (28), (29).

This is also relatively important to indicate the warnings and precautions for Nourisil™ MD as follows:

Warnings/precautions

Justification of warnings

Nourisil™ MD cannot be applied to open wounds, or third degree burn wounds.

Applying Silicone gel immediately after injuries or surgery without allowing reepithelialization is ineffective. See Bibliography listed below: (5)

Nourisil™ MD should not be applied on dermatological conditions that disrupt the integrity of the skin.

Silicone gel used on skin with incomplete reepithelialization is ineffective. See Bibliography listed below: (5)

Also unknown systemic effects could occur.

Direct contact with mucous membranes and the eyes should be avoided.

One of the Nourisil™ MD ingredients can cause slight eye irritation. Also all ingredients were evaluated for the use on mucous membranes and use on these membranes might cause unknown systemic effects.

Keep out of reach of children.

Nourisil™ MD is a translucent gel packaged in an airless dispenser. This can be attractive to children. The accidental intake of large

quantities of Nourisil™ MD is best avoided.

If irritation occurs, the use of the product should be discontinued immediately and a physician should be consulted.

Even though all ingredients used in Nourisil™ MD are considered safe, there is always a possibility for a patient to be hypersensitive to any of the ingredients. As a precaution, use of Nourisil™ MD is in these cases best avoided. See Bibliography listed below:

(12), (13), (19) (20), (21), (22), (23)

Do not use in case of known hypersensitivity for one of the ingredients.

Even though all ingredients used in Nourisil™ MD are considered safe, there is always a possibility for a patient to be hypersensitive to any of the ingredients. As a precaution, use of Nourisil™ MD is in these cases best avoided. See Bibliography listed below:

(12), (13), (19) (20), (21), (22), (23)

When additional topical treatment is used on the same skin area, please consult your doctor.

Nourisil™ MD has an occlusive effect, this might be undesirable when applied soon after other dermatological treatments.

Bibliography

  1. Occlusion regulates epidermal cytokine production and inhibits scar Gallant-Behm CL, Mustoe TA. 2010, Wound Repair Regen. , pp. 235-44.
  1. Functional analyses of the stratum corneum in Sequential studies after injury and comparison among keloids, hypertrophic scars, and atrophic scars. Suetake T, Sasai S, Zhen YX, Ohi T, Tagami H. 12, s.l. : Arch Dermatol, 1998, Vol. 132, pp. 1453-8.
  2. Silicone sheet for treatment and prevention of hypertrophic scar: a new proposal for the mechanism of Gilman TH. 2003, Wound Repair Regen., pp. 235-6.
  1. Scar management by means of occlusion and hydration: a comparative study of silicones versus a hydrating gel- Hoeksema H, De Vos M, Verbelen J, Pirayesh A, Monstrey S. 2013, Burns, pp. 1437-48.
  2. Evolution of silicone therapy and mechanism of action in scar management. Mustoe, TA. 2008, Aesthetic Plast , pp. 82-92.
  3. Skin Bayat A, McGrouther DA, Ferguson MW. s.l. : BMJ, 2003, Vol. 326, pp. 88-92.
  4. Management of keloids and hypertrophic Juckett G, Hartman-Adams H. 3, s.l. : Am Fam Physician, 2009, Vol. 80, pp. 253-60.
  5. Aging alters the inflammatory and endothelial cell adhesion molecule profiles during human cutaneous wound Ashcroft GS, Horan MA, Ferguson MW. 1, s.l. : Lab Invest., 1998, Vol. 78, pp. 47-58.
  6. Going into surgery: Risk factors for hypertrophic Butzelaar L, Soykan EA, Galindo Garre F, Beelen RH, Ulrich MM, Niessen FB, Mink van der Molen AB. 4, s.l. : Wound Repair Regen., 2015, Vol. 23, pp. 531-7.
  7. Management of scars: updated practical guidelines and use of silicones. Meaume S, Le Pillouer-Prost A, Richert B, Roseeuw D, Vadoud Jul-Aug 2014, Eur J Dermatol, pp. 435-43.
  8. The efficacy of topical silicone gel elastomers in the treatment of hypertrophic scars, keloid scars, and post-laser exfoliation Chernoff WG, Cramer H, Su-Huang S. Sep-Oct 2007, Aesthetic Plast Surg, pp. 495-500.
  9. A randomized, placebo-controlled, double-blind, prospective clinical trial of silicone gel in prevention of hypertrophic scar development in median sternotomy wound. Chan KY, Lau CL, Adeeb SM, Somasundaram S, Nasir-Zahari 2005, Plast Reconstr Surg., pp. 1013-20.
  10. Clinical evaluation of a new self-drying silicone gel in the treatment of scars: a preliminary report. Signorini M, Clementoni 2007, Aesthetic Plast Surg. , pp. 183-7.
  11. Comparative effect of topical silicone gel and topical tretinoin cream for the prevention of hypertrophic scar and keloid formation and the improvement of scars. Kwon SY, Park SD, Park K. 2014, J Eur Acad Dermatol , pp. 1025-33.
  12. Topical silicone gel versus placebo in promoting the maturation of burn scars: a randomized controlled

van der Wal MB, van Zuijlen PP, van de Ven P, Middelkoop E. 2010, Plast Reconstr Surg., pp. 524-31.

  1. The use of silicone gel in the treatment of fresh surgical scars: a randomized de Giorgi V, Sestini S, Mannone F, Papi F, Alfaioli B, Gori A, Lotti T. 2009, Clin Exp Dermatol. , pp. 688-93.
  2. Comparison of efficacy of silicone gel, silicone gel sheeting, and topical onion extract including heparin and allantoin for the treatment of postburn hypertrophic Karagoz H, Yuksel F, Ulkur E, Evinc R. 2009, Burns, pp. 1097-103.
  3. Prevention of postsurgical scars: comparsion of efficacy and convenience between silicone gel sheet and topical silicone gel. Kim SM, Choi JS, Lee JH, Kim YJ, Jun 2014, J Korean Med Sci., pp. Suppl 3:S249-53.
  4. Dow Corning . Summary of Health data for Dow Corning ST-Elastomer 2008.
  5. Dow Summary of Health Data for dow corning Ǫ7-9120 Silicone Fluid, 12.500 CST. 2014.
  6. Final report on the safety assessment of Tocopherol, Tocopheryl Acetate, Tocopheryl Linoleate, Tocopheryl Linoleate/Oleate, Tocopheryl Nicotinate, Tocopheryl Succinate, Dioleyl Tocopheryl Methylsilanol, Potassium Ascorbyl Tocopheryl Phosphate, and Zondlo Fiume M. 2002, Int J Toxicol., pp. 21 Suppl 3:51-116.
  7. Safety Assessment of Dimethicone Crosspolymers as Used in Cosmetics. Becker LC, Bergfeld WF, Belsito DV, Hill RA, Klaassen CD, Liebler DC, Marks JG Jr, Shank RC, Slaga TJ, Snyder PW, Andersen FA. 2014, Int J Toxicol. , pp. 65S-115S.
  8. Final report on the safety assessment of stearoxy dimethicone, dimethicone, methicone, amino bispropyl dimethicone, aminopropyl dimethicone, amodimethicone, amodimethicone hydroxystearate, behenoxy dimethicone, C24-28 alkyl methicone, C30-45 alkyl methico. Nair B, Cosmetic Ingredients Review Expert Panel. 2003, Int J , pp. 11-35.
  9. Safety assessment of cyclomethicone, cyclotetrasiloxane, cyclopentasiloxane, cyclohexasiloxane, and Johnson W Jr, Bergfeld WF, Belsito DV, Hill RA, Klaassen CD, Liebler DC, Marks JG Jr, Shank RC, Slaga TJ, Snyder PW, Andersen FA. s.l. : Int J Toxicol., 2011, Vol. 30, pp. 149S-227S.
  10. Scientific Committee on Consumer Safety. Opinion on decamethylcyclopentasiloxane (cyclopentasiloxane, D5) in cosmetic 2015.
  11. A prospective placebo-controlled study on the efficacy of onion extract in silicone derivative gel for the prevention of hypertrophic scar and keloid in median sternotomy wound in pediatric patients. Wananukul S, Chatpreodprai S, Peongsujarit D, Lertsapcharoen 2013, J Med Assoc Thai, pp. 1428-33.
  12. The use of silicon gel for treating children’s burn scars in Saudi Arabia: a case study. Brown CA. 2002, Occup Ther , pp. 121-30.
  13. The Royal Children’s Hospital Melbourne. Scar Management Info. [Online] [Cited: May 4, 2016.] rch.org.au/uploadedFiles/…/InfoSheet_M.pdf.
  14. Seattle Childrens Hospital. Scar Care . [Online] [Cited: May 4, 2016.] www.seattle <http://www.seattle/> org/pdf/PE2043.pdf .

Clinical studies supporting the efficacy of silicone gel in scar management:

Author

Study design

Patients

Intervention

Outcome

Silicone gel vs. placebo or no treatment

Chan et al.

(12)

Prospective, double-blind, RCT50 Asian patients who underwent median sternotomyTwice-daily silicone gel on half of wound compared with placebo gel on other half of wound for 3 monthsScars developed significantly flatter, less red, are more pliable and associated with significantly less pain and itching when treated with silicone gel compared to placebo
Signorini and Clementoni l (13)Prospective, RCT160 patients with fresh surgical scarsTwice-daily silicone gel treatment compared with no treatment for 4 monthsScar quality was significantly better with silicone gel treatment compared to placebo

Kwon et al.

(14)

Prospective, controlled trial

26 patients with

44 wounds

Silicone gel, tretinoin cream or no treatmentSilicone gel effectively prevented hypertrophic scars and keloids
Van der Wal et al. (15)Prospective, double-blind, RCT, within- subject comparison23 patients with burn scarsSilicone gel vs placebo for 1 yearSilicone gel significantly improves the roughness of scars and reduced itching during 6 months

De Giorgi

et al. (16)

Prospective, RCT110 patients with surgical scarsTwice-daily silicone gel vs placebo for 60 daysSilicone gel reduced formation of keloid and hypertrophic scars and paresthesia, pulling sensation and alterations in color.
Silicone gel vs. silicone sheeting
Chernoff et al. (11)Prospective, within subject comparison study30 patients with bilateral hypertrophic/rais ed scars or keloidsSilicone gel, silicone sheeting or combined compared with no treatment for 3 monthsScars treated with silicone gel or silicone sheeting or these two combined were significantly less elevated, less red, and associated with fewer symptoms compared to the untreated scar

Karagoz H

et al. (18)

Prospective, RCT45 patients with post burn scarsSilicone gel vs silicone sheets or topical onion extract for 6 monthsSilicone gel was effective as silicone sheeting in improving scars

Kim et al.

(19)

Prospective, comparative trial30 patient with surgical scarsSilicone sheet vs silicone gel for 3 monthsNo significant difference in efficacy between silicone sheets and gel. Silicone gel was more convenient to use

 Bibliography

  1. Final report on the safety assessment of Tocopherol, Tocopheryl Acetate, Tocopheryl Linoleate, Tocopheryl Linoleate/Oleate, Tocopheryl Nicotinate, Tocopheryl Succinate, Dioleyl Tocopheryl Methylsilanol, Potassium Ascorbyl Tocopheryl Phosphate, and Tocophe. Zondlo Fiume 2002, Int J Toxicol., pp. 21 Suppl 3:51-116.
  2. Updated international clinical recommendations on scar management: part 1–evaluating the evidence. Gold MH, Berman B, Clementoni MT, Gauglitz GG, Nahai F, Murcia C. 8, s.l. : Dermatol Surg, 2014, Plast Reconstr Surg, 40, pp. 817-24.
  3. International clinical recommendations on scar management. Mustoe TA, Cooter RD, Gold MH, Hobbs FD, Ramelet AA, Shakespeare PG, Stella M, Téot L, Wood FM, Ziegler UE, International Advisory Panel on Scar Aug 2002, Plast Reconstr Surg., pp. 560-71.
  4. Management of scars: updated practical guidelines and use of silicones. Meaume S, Le Pillouer-Prost A, Richert B, Roseeuw D, Vadoud Jul-Aug 2014, Eur J Dermatol, pp. 435-43.
  5. Irwin Palefsky, Ni’kita EP2211919 B1 Europe, 2011.
  6. Kinerase Dermatix Ultra Advanced Scar Treatment. [Online] [Cited: 05 02, 2016.] https://www.beautybar.com/p/productname-77261.
  7. Updated scar management practical guidelines: non-invasive and invasive measures. Monstrey S, Middelkoop E, Vranckx JJ, Bassetto F, Ziegler UE, Meaume S, Téot L. Aug 2014, J Plast Reconstr Aesthet , pp. 1017-25.
  8. Efficacy and Safety of a Novel 100% Silicone Scar Gel Treatment for Early Intervention in Scar DJ., Goldberg. 9(12):13-20, s.l. : J Clin. Aestet. Dermatol., 2016, Vol. 2016 Dec 1.
  9. Review of Silicone Gel Sheeting and Silicone Gel for the Prevention of Hypertrophic Scars and Hsu KC, Luan CW, Tsai YW. 29(5), s.l. : Wounds, May 2017, pp. 154-158.
  1. Silicone gel sheeting for preventing and treating hypertrophic and keloid O’Brien L, Jones DJ. s.l. : Cochrane Database Syst Rev., 2013.
  1. The efficacy of topical silicone gel elastomers in the treatment of hypertrophic scars, keloid scars, and post-laser exfoliation Chernoff WG, Cramer H, Su-Huang S. Sep-Oct 2007, Aesthetic Plast Surg, pp. 495-500.
  2. A randomized, placebo-controlled, double-blind, prospective clinical trial of silicone gel in prevention of hypertrophic scar development in median sternotomy wound. Chan KY, Lau CL, Adeeb SM, Somasundaram S, Nasir-Zahari M. 2005, Plast Reconstr , pp. 1013-20.
  3. Clinical evaluation of a new self-drying silicone gel in the treatment of scars: a preliminary report. Signorini M, Clementoni MT. 2007, Aesthetic Plast Surg. , pp. 183-7.
  1. Comparative effect of topical silicone gel and topical tretinoin cream for the prevention of hypertrophic scar and keloid formation and the improvement of scars. Kwon SY, Park SD, Park 2014, J Eur Acad Dermatol Venereol., pp. 1025-33.
  2. Topical silicone gel versus placebo in promoting the maturation of burn scars: a randomized controlled van der Wal MB, van Zuijlen PP, van de Ven P, Middelkoop E. 2010, Plast Reconstr Surg., pp. 524-31.
  3. The use of silicone gel in the treatment of fresh surgical scars: a randomized de Giorgi V, Sestini S, Mannone F, Papi F, Alfaioli B, Gori A, Lotti T. 2009, Clin Exp Dermatol. , pp. 688-93.
  4. Randomised comparison of silicone gel and onion extract gel for post-surgical. Song T, Kim KH, Lee 702-707, s.l. : J Obstet Gynaecol., 2018, Vol. 38(5).
  5. Comparison of efficacy of silicone gel, silicone gel sheeting, and topical onion extract including heparin and allantoin for the treatment of postburn hypertrophic scars. Karagoz H, Yuksel F, Ulkur E, Evinc R. 2009, Burns, 1097-103.
  6. Prevention of postsurgical scars: comparsion of efficacy and convenience between silicone gel sheet and topical silicone gel. Kim SM, Choi JS, Lee JH, Kim YJ, Jun YJ. 2014, J Korean Med Sci., pp. Suppl 3:S249-53.
  7. Silicone sheet for treatment and prevention of hypertrophic scar: a new proposal for the mechanism of Gilman TH. 2003, Wound Repair Regen., pp. 235-6.
  8. Scar management by means of occlusion and hydration: a comparative study of silicones versus a hydrating gel-cream. Hoeksema H, De Vos M, Verbelen J, Pirayesh A, Monstrey 2013, Burns, pp. 1437-48.
  9. Occlusion regulates epidermal cytokine production and inhibits scar formation. Gallant-Behm CL, Mustoe 2010, Wound Repair Regen. , pp. 235-44.
  10. Evolution of silicone therapy and mechanism of action in scar management. Mustoe, 2008, Aesthetic Plast Surg., pp. 82-92.
  11. Vitamin E added silicone gel sheets for treatment of hypertrophic scars and keloids. Palmieri B, Gozzi G, Palmieri 1995, Int J Dermatol., pp. 506-9.
  12. The use of silicone gel sheeting in the management of hypertrophic and keloid scars. Poston 2000, J Wound Care., pp. 10-6.
  1. Silicone gel sheeting in scar therapy. Katz 1995, Cutis., pp. 65-7.
  2. Comparison of a silicone gel-filled cushion and silicon gel sheeting for the treatment of hypertrophic or keloid Berman B, Flores F. 1999 , Dermatol Surg., pp. 484-6.
  3. A controlled clinical trial of topical silicone gel sheeting in the treatment of hypertrophic scars and keloids. Gold 1994, J Am Acad Dermatol, pp. 506-7.
  4. A prospective placebo-controlled study on the efficacy of onion extract in silicone derivative gel for the prevention of hypertrophic scar and keloid in median sternotomy wound in pediatric patients. Wananukul S, Chatpreodprai S, Peongsujarit D, Lertsapcharoen P. 2013, J Med Assoc Thai, pp. 1428-
  5. The use of silicon gel for treating children’s burn scars in Saudi Arabia: a case study. Brown 2002, Occup Ther Int. , pp. 121-30.
  1. Seattle Childrens Scar Care . [Online] [Cited: May 4, 2016.] www.seattle <http://www.seattle/> childrens.org/pdf/PE2043.pdf .
  1. The Royal Children’s Hospital Scar Management Info. [Online] [Cited: May 4, 2016.] www.rch.org.au/uploadedFiles/…/InfoSheet_M.pdf.
  2. Safety assessment of cyclomethicone, cyclotetrasiloxane, cyclopentasiloxane, cyclohexasiloxane, and cycloheptasiloxane. Johnson W Jr, Bergfeld WF, Belsito DV, Hill RA, Klaassen CD, Liebler DC, Marks JG Jr, Shank RC, Slaga TJ, Snyder PW, Andersen 2011, Int J Toxicol., pp. 149S-227S.
  3. Scientific Committee on Consumer Safety. Opinion on decamethylcyclopentasiloxane (cyclopentasiloxane, D5) in cosmetic [Online] March 25, 2015. [Cited: May 2016, 04.] http://ec.europa.eu/health/scientific_committees/consumer_safety/docs/sccs_o_174.pdf.
  4. Opinion of the Scientific Committee on Consumer Safety (SCCS) – Final version of the opinion on decamethylcyclopentasiloxane (cyclopentasiloxane, D5) in cosmetic products. Rousselle : n.
  5. Dow Corning . Summary of Health data for Dow Corning ST-Elastomer 2008.
  6. Dow Corning Email contact. 2015.
  7. Scientific Committee on Consumer Safety Assessment of Tocopherols and Tocotrienols as Used in Cosmetics. Final amended report. [Online] April 4, 2014. [Cited: May 4, 2016.] http://www.cir-safety.org/sites/default/files/tocoph032014FR.pdf.
  8. Allergic contact dermatitis caused by VEA(®) lipogel:compound allergy? Milanes N, Gola M, Francalanci.
  1. Safety Assessment of Dimethicone Crosspolymers as Used in Cosmetics. Becker LC, Bergfeld WF, Belsito DV, Hill RA, Klaassen CD, Liebler DC, Marks JG Jr, Shank RC, Slaga TJ, Snyder PW, Andersen 2014, Int J Toxicol. , pp. 65S-115S.
  2. Contact Sensitization to Emulsifying Agents: An Underrated Issue? Corazza M, Virgili A, Ricci M, Bianchi A, Borghi A.
  1. Final report on the safety assessment of stearoxy dimethicone, dimethicone, methicone, amino bispropyl dimethicone, aminopropyl dimethicone, amodimethicone, amodimethicone hydroxystearate, behenoxy dimethicone, C24-28 alkyl methicone, C30-45 alkyl methico. Nair B, Cosmetic Ingredients Review Expert 2003, Int J Toxicol., pp. 11-35.
  2. Dow Summary of Health Data for dow corning Q7-9120 Silicone Fluid, 12.500 CST.2014.
  1. Effects of silicone gel on burn Momeni M, Hafezi F, Rahbar H, Karimi H. 2009, Burns, pp. 70-4.
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