Pseudocatalase Physician Information

 

In studies the ingredients used in pseudocatalase are thought to act in the removal of high levels of epidermal hydrogen peroxide, thereby stabilizing the depigmentation phase of the disorder and initiating the repigmentation of the skin.(32)

 

Clinical studies conducted worldwide are holding great promise, as their results are only positive ones.  Take for instance, a study consisting of thirty-three patients living with vitiligo who were treated with a topical application of pseudocatalase, calcium, and a short-term exposure to UVB light.  It was found that the first sign of repigmention occurred as early as 2 to 4 months after the initiation of therapy and complete repigmentation on the face and hands of patients was seen in 90% of the group.  It was also noted that no patients developed new lesions while on the therapy.(34)  In another similar study involving fifty-nine patients who were treated for 21 days with the combination treatment of Dead Sea climatotherapy plus pseudocatalase cream (PC-KUS), it was discovered that only after 15 minutes of Dead Sea bathing, there was a significantly higher decrease of epidermal hydrogen peroxide compared to the use of narrow-band UVB along with the pseudocatalase cream.  It was observed that between days 10 and 16 after initiation of therapy that patients already regained the beginning stages of repigmentation compared to the 2 to 4 months discussed earlier.  As a result, this study concluded that this combined therapy produced a significantly faster response in repigmentation of patient’s skin than the use of pseudocatalase, calcium, and UVB treatment alone.  The study supported the idea that not only is it important to remove epidermal hydrogen peroxide, but also for a successful treatment against vitiligo, solar UV-light is of equal importance.(35)

 

At the moment, the mainstream treatment against this discolorating disorder has no side effects, even maintaining the affected patient’s normal liver function.(33)

 

As you can see, the road in the treatment for vitiligo looks promising as more and more knowledge about the disorder is being discovered, thus allowing doctors and pharmacists all around the world to develop future therapies.

 

Proposed Mechanism of Action Narrow-band activated pseudocatalase cream (PC-KUS) is based on a bis manganese EDTA bicarbonate complex, which removes high levels of epidermal H2O2. As a result, it initiates repigmentation and arrests further development of vitiligo(11).

 

Recommended Application -  Apply pseudocatalase twice daily along with exposure to natural sunlight or 2-3 times a week UVB phototherapy(11)

 

Adverse effects - Generally well tolerated without reported common or serious side effects. A few instances of increased sweating and hyperpigmentation has been reported, which subsided with continued use(11).

 

Have there been studies done on pseudocatalase?

In 1995, Dr. Karin Schallreuter and her colleagues published case studies on 33 patients, reporting complete repigmentation of face and dorsum of the hand in 90% (fingers and feet did not repigment)(18,6). Pseudocatalase and calcium combination cream were applied twice daily, along with twice a week UVB phototherapy. The treatment period was averaged to be 15 months, but the first sign of repigmentation appeared between 2 and 4 months.

 

Additionally, a study published in 2008 entitled “From basic research to the bedside: efficacy of topical treatment with pseudocatalase PC-KUS in 71 children with vitiligo” assessed the effect of repigmentation in 71 children with vitiligo in various countries. After 8-12 months of treatment with topical PC-KUS twice daily, more than 75% repigmentation of the face and neck occurred in 66 of the 71 patients, more than 75% repigmentation of the trunk in 48 of the 61 patients, more than 75% repigmentation of the extremities in 40 of the 55 patients, and 75% repigmentation of the hands and feet in 5 of the 53 patients(20). These remarkable results add to the prospects of considering pseudocatalase as a treatment option for vitiligo.

 

Some other clinical trials have not shown as favorable results. In 2002, an open study assessed the effectiveness of pseudocatalase applied twice daily in combination with UVB phototherapy over a period of 24 weeks. Of the 26 patients studied, ten of the patients showed improvements while the remaining patients did not show improvement or even worsening of the condition. However, the supplied pseudocatalase was formulated as a mousse, which was different from the original formulation. This may have contributed to the poor results and reported side effects of itching(29).

 

Subsequently, in 2009, Bakis-Petsoglou and team conducted a randomized, double-blinded, placebo-controlled trial of twice daily pseudocatalase along with three times a week UVB phototherapy over a period of 24 weeks. In this study, 32 patients were randomized to the pseudocatalase or placebo arm (the placebo group received a cream that looked like pseudocatalase but did not contain any active ingredients). By week 12, both groups showed statistically significant improvement, which continued throughout the rest of the trial. However, results did not show that pseudocatalase added improvement to UVB phototherapy over placebo(21). According to Dr. Karin Schallreuter’s response to these two trials, both of these did not use the original formulation and certify that activated pseudocatalase has shown excellent results in patients treated(22).

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Vitiligo Treatment References:

(1) Lebwohl MG, et al. (2006). Vitiligo. Treatment of Skin Disease: Comprehensive Therapeutic Strategies (2nd edition, pp. 683-687). Elsevier.

(2) NIH. (2010 Nov). What Is Vitiligo? Fast Facts: An Easy-to-Read Series of Publications for the Public. National Institute of Arthritis and Musculoskeletal and Skin Disease. Retrieved September 2, 2013 from http://www.niams.nih.gov/Health_Info/Vitiligo/vitiligo_ff.asp.

(3) Alikhan A, Felsten LM, Daly M, Petronic-Rosic V. Vitiligo: a comprehensive overview Part I. Introduction, epidemiology, quality of life, diagnosis, differential diagnosis, associations, histopathology, etiology, and work-up. J Am Acad Dermatol. 2011 Sep;65(3):473-91.

(4) AAD. (2013). Vitiligo: Signs and symptoms. American Academy of Dermatology. Retrieved September 2, 2013 from http://www.aad.org/dermatology-a-to-z/diseases-and-treatments/u---w/vitiligo/signs-symptoms

(5) AAD. (2013). Vitiligo: Who gets and causes. American Academy of Dermatology. Retrieved September 2, 2013 from http://www.aad.org/dermatology-a-to-z/diseases-and-treatments/u---w/vitiligo/who-gets-causes

(6) Gawkrodger DJ. Pseudocatalase and narrowband ultraviolet B for vitiligo: clearing the picture. Br J Dermatol. 2009 Oct;161(4):721-2.

(7) Felsten LM, Alikhan A, Petronic-Rosic V. Vitiligo: a comprehensive overview Part II: treatment options and approach to treatment. J Am Acad Dermatol. 2011 Sep;65(3):493-514.

(8) Silverberg JI, Silverberg AI, Malka E, Silverberg NB. A pilot study assessing the role of 25 hydroxy vitamin D levels in patients with vitiligo vulgaris. J Am Acad Dermatol. 2010 Jun;62(6):937-41.

(9) Gawkrodger DJ, Ormerod AD, Shaw L et al. Guideline for the diagnosis and management of vitiligo. Br J Dermatol 2008; 159: 1051-76.

(10) AAD. (2013). Vitiligo: Diagnosis, treatment, and outcome. American Academy of Dermatology. Retrieved September 2, 2013 from http://www.aad.org/dermatology-a-to-z/diseases-and-treatments/u---w/vitiligo/diagnosis-treatment

(11) Schallreuter KU, Moore J, Behrens-Williams S, Panske A, Harari M. Rapid initiation of repigmentation in vitiligo with Dead Sea climatotherapy in combination with pseudocatalase (PC-KUS). Int J Dermatol. 2002 Aug;41(8):482-7.

(12) AVRF. (2013). Medical treatments. American Vitiligo Research Foundation. Retrieved September 2, 2013 from http://www.avrf.org/treatments/medical.htm

(13) Kriegel MA, Manson JE, Costenbader KH. Does vitamin D affect risk of developing autoimmune disease?: a systematic review. Semin Arthritis Rheum. 2011 Jun;40(6):512-531.

(14) Travis LB, Silverberg NB. Calcipotriene and corticosteroid combination therapy for vitiligo. Pediatr Dermatol 2004;21: 495-8.

(15) AVRF. (2013). Surgical treatments. American Vitiligo Research Foundation. Retrieved September 2, 2013 from http://www.avrf.org/treatments/surgical.htm

(16) Papadopoulos L, Bor R, Legg C. Coping with the disfiguring effects of vitiligo: a preliminary investigation into the effects of cognitive-behavioural therapy. Br J Med Psychol 1999; 72(pt 3):385-96.

(17) Schallreuter KU, Moore J, Behrens-Williams S, Panske A, Harari M. Rapid initiation of repigmentation in vitiligo with Dead Sea climatotherapy in combination with pseudocatalase (PC-KUS). Int J Dermatol. 2002 Aug;41(8):482-7.

(18) Schallreuter KU, Wood JM, Lemke KR, Levenig C. Treatment of vitiligo with a topical application of pseudocatalase and calcium in combination with short-term UVB exposure: a case study on 33 patients. Dermatology. 1995;190(3):223-9.

(19) Gawkrodger DJ. Pseudocatalase and narrowband ultraviolet B for vitiligo: clearing the picture. Br J Dermatol. 2009 Oct;161(4):721-2.

(20) Schallreuter KU, Krüger C, Würfel BA, Panske A, Wood JM. From basic research to the bedside: efficacy of topical treatment with pseudocatalase PC-KUS in 71 children with vitiligo. Int J Dermatol. 2008 Jul;47(7):743-53.

(21) Bakis-Petsoglou S, Le Guay JL, Wittal R. A randomized, double-blinded, placebo-controlled trial of pseudocatalase cream and narrowband ultraviolet B in the treatment of vitiligo. Br J Dermatol. 2009 Oct;161(4):910-7.

(22) Schallreuter KU. Effectiveness of pseudocatalase formulations in vitiligo. Clin Exp Dermatol. 2003 Sep;28(5):562-3.

(23) Schallreuter KU, Salem MA, Holtz S, Panske A. Basic evidence for epidermal H2O2/ONOO--mediated oxidation/nitration in segmental vitiligo is supported by repigmentation of skin and eyelashes after reduction of epidermal H2O2 with topical NB-UVB-activated pseudocatalase PC-KUS. FASEB J. 2013 Aug;27(8):3113-22.

(24) Bazian. (2013, May 12). No evidence of cure to prevent hair going grey. NIH Behind the headlines. Retrieved on September 2, 2013 from http://www.ncbi.nlm.nih.gov/pubmedhealth/behindtheheadlines/news/2013-05-12-no-evidence-of-cure-to-prevent-hair-going-grey/

(25) Genes. (2013, Sept 23). TYR. Genetics Homes Reference. Retrieved September 25, 2013 from http://ghr.nlm.nih.gov/gene/TYR

(26) Schallreuter KU, Moore J, Wood JM, Beazley WD, Peters EM, Marles LK, Behrens-Williams SC, Dummer R, Blau N, Thöny B. Epidermal H(2)O(2) accumulation alters tetrahydrobiopterin (6BH4) recycling in vitiligo: identification of a general mechanism in regulation of all 6BH4-dependent processes? J Invest Dermatol. 2001 Jan;116(1):167-74.

(27) Brazzelli V, Antoninetti M, Palazzini S, Barbagallo T, De Silvestri A, Borroni G. Critical evaluation of the variants influencing the clinical response of vitiligo: study of 60 cases treated with ultraviolet B narrow-band phototherapy. J Eur Acad Dermatol Venereol 2007;21:1369-74.

(28) Percivalle S, Piccinno R, Caccialanza M, Forti S. Narrowband ultraviolet B phototherapy in childhood vitiligo: evaluation of results in 28 patients. Pediatr Dermatol. 2012 Mar-Apr;29(2):160-5.

(29) Patel DC, Evans AV, Hawk JL. Topical pseudocatalase mousse and narrowband UVB phototherapy is not effective for vitiligo: an open, single-centre study. Clin Exp Dermatol. 2002 Nov;27(8):641-4.

(30) www.vitiligosupport.com/whatis.cfm  Accessed April 18, 2005

(31) http://www.niams.nih.gov/hi/topics/vitiligo/vitiligo.htm  Accessed April 18, 2005

(32) http://www.homephototherapy.com/vit-pcat.htm  Accessed April 18, 2005

(33) http://www.brad.ac.uk/acad/biomed/STAFF/KUS/home.html  Accessed April 19,2005

(34) Schallreuter KU, Wood JM, Lemke KR, Levenig C.  Treatment of vitiligo with a topical application of pseudoctalase and calcium in combination with short-term UVB exposure: a case study on 33 patients.  Dermatology.  1995;190(3):223-9.

(35) Schallreuter KU, Moore J, Behrens-Williams S, Panske A, Harari M.  Rapid initiation of repigmentation in vitiligo with Dead Sea climatotherapy in combination with pseudocatalase (PC-KUS).  International Journal of Dermatology.  2002;41(8):482-7.