Kelo-Cote

Product Summary

Kelo-Cote is a patented topical silicone gel for the management and prevention of abnormal scars in the form of hypertrophic and keloid scars resulting from general surgical procedures, trauma, wounds and burns. Kelo-Cote’s clinically proven formula self-dries within 4-5 minutes to form a waterproof, gas permeable membrane which acts like an extra layer of skin.

It helps soften, flatten, and smooth raised scars, whilst maintaining the moisture balance and elasticity of the adjacent skin. It also reduces discolouration, redness, and associated itching, pain and discomfort of scars. Kelo-Cote can be used on flexures, joints, and irregular surfaces as well as large scar areas. It can also be used in conjunction with other treatment options such as pressure garments.

Make-up and sun protection can be applied once Kelo-Cote has dried.

Kelo-Cote provides 24-hour protection with just 2 applications per day.

Alliance Pharmaceuticals manufactures Kelo-Cote and is also responsible for the marketing and distribution of the product in the UK.

Silicone gels are the first line recommended treatment for hypertrophic and keloid scars by healthcare professionals, including plastic surgeons.

The Kelo-Cote range is made up of 3 different presentations, and 6 products in total;
Kelo-Cote Gel is available in 6g, 15g and 60g.
Kelo-Cote UV Gel is available in 6g and 15g.
Kelo-Cote Spray is available as a 100ml propellant spray can.

What does it contain?

Kelo-Cote features the Siliclear Complex, a precise blend of bio-inert and bio-compatible silicone, namely Polysiloxane, silicone dioxide and silicone components. Silicone dioxide cross-links with polymers to form a silicone sheet on the skin.

Kelo-Cote Gel - Polysiloxanes, Silicone Dioxide
Kelo-Cote UV – Polysiloxanes, Silicone Dioxide, Octinoxate, Octisalate, Octocrylene, Oxybenzone, Isopropyl Myristate
Kelo-Cote Spray – Polysiloxanes, Silicone Dioxide, Butane, Pentane

How does it work?

This invisible sheet binds to the outer layer of dead skin cells to protect the underlying tissue against chemical, physical, and microbial invasion of the scar. It also provides an optimal healing environment by hydrating and protecting the area and allowing collagen production to normalise and improve the appearance of scars.

Kelo-Cote and Kelo-Cote UV Usage Instructions

Start using Kelo-Cote as soon as your wound is closed, or the stitches are removed. Ensure the wound area is clean and dry. Apply a very thin layer of Kelo-Cote Gel onto the scar twice a day – do not rub in. Kelo-Cote self-dries within 5 minutes forming a flexible, waterproof, transparent layer. Remove any excess product if it does not dry completely. Once dry, sunblock and cosmetics can be applied. The recommended minimum treatment time is 60-90 days. If improvement still occurs after 90 days, continued use is recommended.

Kelo-Cote Spray Usage Instructions

Start using Kelo-Cote Spray as soon as your wound is closed, or the stitches are removed. Shake can well before use. Ensure that the effected area is clean and dry. Remove cap from the can. Hold the can 6 to 8 inches from the surface to be treated. Spray across the length of the scar in a light, sweeping motion. Kelo-Cote Spray should be applied in a very thin, even coating with no holes or gaps in the affected area. Allow to air dry before covering with sun block or pressure garments. Kelo-Cote Spray should dry in 2-3 minutes. If it is pooling, dripping, or running, you have sprayed too much. Gently remove the excess and allow the drying process to continue.

What does it claim to treat?

Treatment and prevention of hypertrophic and keloid scars resulting from burns, general surgical procedures and trauma wounds, up to 4 years old.

Product range

Kelo-Cote Gel (6g, 15g, 60g)

Easy to use, fast drying gel which helps to soften and flatten raised scars and reduce redness.

Clinically proven formula that dries in less than 5 minutes to create a flexible and waterproof barrier.

Kelo-Cote UV Gel

All the benefits of the standard gel, but with added SPF 30 to protect scars from the aggravating effects of the sun. Clinically proven formula that dries in less than 5 minutes to create a flexible and waterproof barrier.

Scarring can be increased further if the scar is exposed to the sun during the healing period. It may become bigger, harder, and darker in colour. Scars lack melanin (the pigment that gives our skin colour and provides some protection from the sun), so it’s even more important to make sure scars are not exposed to the harmful effects of the sun.

Kelo-Cote Spray

Convenient for use with large scars, or those which are sensitive to touch, such as burn scars. Hygienic spray presentation, so no need to touch the affected area.

Not to be used in

Not to be used on open wounds, mucous membranes, or any other dermatological conditions that disrupt the integrity of the skin.

Duration of effects

The recommended minimum treatment time is 60-90 days. If improvement still occurs after 90 days, continued use is recommended.

Reported side effects

There are no known side effects when using Kelo-Cote Gel.

Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard. Adverse events should also be reported to Alliance Pharmaceuticals Ltd at pharmacovigilance@alliancepharma.co.uk or 01249 466966

Costs

Kelo-Cote is available in some private clinics, local pharmacies, and online in participating retailers. Prices may vary dependent on the retailer.

RRP:
Kelo-Cote Gel 6g – £19.49
Kelo-Cote Gel 15g - £32.18
Kelo-Cote Gel 60g – £91.80
Kelo-Cote UV 6g - £19.99
Kelo-Cote UV 15g - £31.50
Kelo-Cote Spray - £91.80

Clinical Data

Please find a summary of the key clinical papers below. The Kelo-Cote formulation is used in all studies below. Please note that the Kelo-Cote formulation was under the brand name Dermatix prior to September 2007.

The 2014 International Clinical Recommendations for Scar Management positions silicone gels or sheeting as first-line for treatment and prevention of hypertrophic and keloid scars after surgery or trauma.¹

 

Primary Author Year Treatment / Prevention Key details Conclusion/Summary
2 Sepehrmanesh 2006 Treatment

 Observational study

1522 patients
Outcome measures: redness, itchiness, pain and elevation of hypertrophic and keloid scars
Predominantly scars less than 3 months
Some scars up to 4 years old included

 70 to 84.2% of physicians reported improvement in the various scar symptoms

The patient evaluation was consistent with the physician evaluation 

3 Signorini 2007 Prevention

160 patients (80 patients in treatment arm, 72 of which completed)

Age ranges 5 to 82 years
Patients had undergone surgery 10 days to 3 weeks previously

Fresh surgical scars treated with the tested product showed significantly better outcomes than those untreated in a prospective trial involving a group of 160 patients.

4 Chernoff 2007 Treatment

90 day prospective study

30 patients
Outcome measures: scar topography before and after punch biopsies

 

The results of this study indicate that Dermatix is a useful treatment for the management of abnormal scarring.

Both Dermatix and silicone gel sheeting reduced symptoms of itching, irritation, and skin maceration
5 Fonseca 2007

Prevention

Prospective, open label, controlled study

131 patients
Compared efficacy of silicone gels and sheets (used twice daily for a minimum of 1 month)
Follow up at 2, 4 and 6 months
Outcome measures: reduction in redness, scar hardness

Topical silicone gel was significantly better tolerated than gel sheeting.

Topical silicone gel provided greater improvement in patient symptoms than gel sheeting
6 Sebastian 2004 Treatment

Observational study

111 patients
75% of scars were less than 2 years old
Outcome measures: redness, pain, hardness, elevation and itching

 

“Changes in score were compared between baseline (baseline) and last evaluation (last). Changes in all parameters tested (Redness, Pain, Hardness, Elevation and Itchiness) between “baseline” and “last” were statistically significant (p 0.005 (Wilcoxon-Test)”

7 Chan 2005 Prevention

50 wounds in treatment arm

Placebo controlled, double blind clinical trial
Age ranges 26 to 77
Vancouver scar scale used

 

Significant differences in scar pigmentation, vascularity, pliability, height, pain and itchiness all observed in treatment arm

“The effect of silicone gel in prevention of hypertrophic scar development in sternotomy wounds is promising’’
8 Puri 2009 Treatment

30 patients with hypertrophic or keloid scars

Silicone gel applied twice daily
Size and colour of scar assessed monthly

After treatment, improvement was noted in the scars

 

9 Radwanski 2010 Prevention

Prospective clinical study carried out in Rio de Janeiro

128 patients with surgical wound scars – longitudinal analysis in 69
Silicone gel applied twice daily for 3-6 months
Vancouver scar scale used for assessment

Statistically significant improvement in scars observed (P <0.0001), especially in the first 3 months

Significant improvement in itching and sensitivity (P<0.0001)

 

10 Stoffels 2010

Prevention

Placebo controlled, double blind, single centre study

20 patients with two new linear scars (in some patients one scar treated with silicone spray and the other with placebo, in patients with a long scar, half the scar was treated with silicone spray, the other half was treated with placebo)
Outcome measures: Vancouver scare scale, scar aesthetics, pain, itching and patient satisfaction
Measured at 3 and 6 months

Significant differences observed at 3 months between spray and placebo for elevation, softness and vascularity

No perceived difference in pain and itching between spray and placebo
Patient satisfaction improved for spray over placebo

 

11 Medhi 2013 Prevention

Open label, prospective trial

Patients had undergone surgery 10 days – 3 weeks prior
Application of Kelo-Cote twice daily for 3 months
Outcome measures: pigmentation, vascularity, pliability, height of scar, pain and pruritis as measured by the Vancouver Scar Scale
36 patients

 

At baseline, height of the scar was 2–5 mm in 57.6 % (19/33) of the subjects which was reduced in subsequent visits (P0.05).

Hyperpigmentation (score 3) was present in 91% (30/33) of patients at baseline and was reduced to normal (score 0) after 2 months of treatment in 40% (6/14) of patients (P = 0.0313).

Vascularity (54.6%, 18/33) at baseline was also reduced over the 3 months period (P = 0.0313) significant decrease (30%, 3/10) (P = 0.0313) in pliability was seen after 3 months of treatment from the baseline (57.6%, 19/33).

Only two patients reported pruritus and pain at the baseline visit; one patient reported improvement after treatment. Itching was reported as an adverse drug reaction in two patients. 

12 Kong 2014 Treatment

100 total knee arthroplasty patients randomised into a silicone gel group vs. placebo

Postoperative scar pain and pruritus were evaluated using a VAS at 3, 6 and 12 months. Scar assessment using the Vancouver scar scale was also carried out.
Although silicone gel group showed better pigmentation and height scales than placebo group (P < 0.05), there were no significant differences in the postoperative scar pain and pruritus VAS scores between the groups (P > 0.05).
13 Steinstraesser Treatment

Kelo-cote Spray

Single center randomised controlled trial
43 patients of which 38 completed to follow up at 18 months following treatment for 12 months
Each with two comparable areas of split-thickness grafted burn wounds
Patient randomised to two treatment groups:
Compression garments plus Kelo-cote Spray vs. Compression alone
Compression garments plus silicone gel sheeting vs. Compression alone
Assessment - Vancouver Scar Scale, chromometry, profilometry, and photographic documentation
Use of pressure garment therapy alone produced results equivalent to those of combined silicone and pressure garment therapy in the prevention of hypertrophic scars. Both significantly improved scores as measured by the VSS. The efficacy of silicone spray therapy was comparable to that of silicone gel sheet therapy in the prevention of hypertrophic scars. Patients treated with silicone spray had fewer side effects when compared with the silicone sheet group.

References:

  1. Gold, M.H., McGuire, M.D., Mustoe, T.A. et al. Updated International Clinical Recommendations on Scar Management: Part 2 – Algorithms for Scar Prevention and Treatment. 2014. Dermatol Surg. 40: 825-831.
  2. Sepehrmanesh, M. Scar Management: Observational study of 1522 patients using the patented Kelo-cote Silicone Gel Technology. 2006 Komp Dermatologie 1: 30-32.
  3. M. Signorini, M.T. Clementoni. Clinical evaluation of a new self-drying silicone gel in the treatment of scars: a preliminary report. 2007 Aesthetic Plastic Surgery. 31(2):183-7.
  4. W.G Chernoff, H. Cramer, S. Su-Huang. The efficacy of topical silicone gel elastomers in the treatment of hypertrophic scars, keloid scars, and post-laser exfoliation erythema. 2007 Aesthetic Plastic Surgery. 31: 495-500.
  5. Fonseca Capdevila, E., Bran, L. E. et al. Prevention of scar sequels after excision of benign. 2007 Piel 22(9): 421-6.
  6. Sebastian, G., Buxbaum-Conradi, H., Fischer, S., Hauschild, T., Worle, B., Sattler, G. Efficacy and tolerability of a novel Silicon gel for scar treatment. 2004 Akt. Dermatological 30: 450
  7. Chan, Y.K., Lan, L.C., Adeeb, S.M., Somasundaram, S. and Nasir-Zahari, M. A randomized, Placebo-Controlled, Double Blind, Prospective Clinical Trial of Silicone Gel in Prevention of Hypertrophic Scar Development in Median Stermotomy Wound. 2005. Plastic and Reconstructive Surgery 116(4):
  8. Puri, N. Talwar, A. The Efficacy of Silicone Gel for the Treatment of Hypertrophic Scars and Keloids. 2009. Journal of Cutaneous and Aesthetic Surgery 2(2): 104-106.
  9. Radwanski, N.H., Elizabeth, W., Correa, M., et al. Silicone Gel in Plastic Surgery Scars: prospective clinical study. 2010. Revista Brasileira de Cirurgia Plástica 25(3): 428-33.
  10. Stoffels, I., Walter, T.P., Sailer, A.M. Pallua, N. Influence of Silicon Spray on Scar Formation. 2010. Der Hautarzt
  11. Medhi, B. et al. Efficacy and safety of an advanced formula silicone gel for prevention of post-operative scars. 2013. Dermatol Ther. 3:157-167.
  12. Kong, C.G., et al. The effect of topical scar treatment on postoperative scar pain and pruritus after total knee arthroplasty. 2013. Arch Orthop Trauma Surg. 134: 555-559.
  13. Steinstraesser, et al. Pressure Garment Therapy Alone and in Combination with Silicone for the Prevention of Hypertrophic Scarring: Randomized Controlled Trial with Intraindividual Comparison

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