Clinical trial of combination therapy for the efficacy, safety, tolerability and improvements in quality of life in patients with moderate to severe plaque psoriasis
Background: Psoriasis is an autoimmune disorder with clinical manifestations scales, inflammation and dryness. The psoriatic skin behaves differently in concurrence with circadian rhythm. Cell division increases in late night and early morning hours. Enzymatic activity will be more during day time. To balance these variations a 24×7 protection is required. The objective of the present study is to find the improvement in Psoriasis condition with the Combination therapy compared to single drug usage.
Methods: A clinical trial for 4 weeks was conducted among psoriasis patients with psorolin oil vs. combination therapy (Dr. JRK’s 777 oil, psorolin ointment, psorolin oil and psorolin medicated bathing bar) and the clinical relief was measured among both groups by following parameters like psoriasis area and severity index (PASI), Physician’s global assessment (PGA), dermatology life quality index (DLQI), subjective self-assessment questionnaire (SSAQ) and subject investigational product feedback questionnaire (SIPFBQ).
Results: Combination therapy (1-3-2 topical therapy) of Dr. JRK’s 777 oil, psorolin ointment, psorolin oil and psorolin medicated bathing bar as a treatment regimen was found to be more effective in the treatment of psoriasis.
Conclusions: 1-3-2 topical therapy is useful in severe psoriasis conditions and recommended for long term effective treatment of psoriasis.
Sobell JM1, Foley P, Toth D, Mrowietz U, Girolomoni G, Goncalves J, et al. Effects of Apremilast on Pruritus and Skin Discomfort/Pain Correlate with Improvements in Quality of Life in Patients with Moderate to Severe Plaque Psoriasis. Acta Derm Venereol. 2016;96:514–20.
Lebwohl MG, Bachelez H, Barker J, Girolomoni G, Kavanaugh A, Langley RG, et al. Patient perspectives in the management of psoriasis: results from the population based Multinational Assessment of Psoriasis and Psoriatic Arthritis Survey. J Am Acad Dermatol. 2014;70:871–81.
Reich A, Hrehorow E, Szepietowski JC. Pruritus is an important factor negatively influencing the well-being of psoriatic patients. Acta Derm Venereol. 2010;90:257–63.
Parisi R, Symmons DP, Griffiths CE, Ashcroft DM. Global epidemiology of psoriasis: a systematic review of incidence and prevalence. J Invest Dermatol. 2013;133:377–85.
Gelfant S, Ozawa A, Chalker DK, Smith JG. Circadian rhythms and differences in epidermal and dermal cell proliferation in uninvolved and involved psoriatic skin in vivo. J Invest Dermatol. 1982;78:58-62.
Schafer I, Hacker J, Rustenbach SJ, Radtke M, Franzke N, Augustin M. Concordance of the Psoriasis Area and Severity Index (PASI) and patient-reported outcomes in psoriasis treatment. Eur J Dermatol 2010;20:62–7.
Basra MK, Salek MS, Camilleri L, Sturkey R, Finlay AY. Determining the minimal clinically important difference and responsiveness of the Dermatology Life Quality Index (DLQI): further data. Dermatology. 2015;230:27–33.
Hongbo Y, Thomas CL, Harrison MA, Salek MS, Finlay AY. Translating the science of quality of life into practice: What do dermatology life quality index scores mean? J Invest Dermatol. 2005;125:659–64.
Kuchekar AB, Pujari RR, Kuchekar SB, Dhole SN, Mule PM. Psoriasis: A comprehensive review. Int J Pharmacy Life Sci. 2011;2(6):857-77.
Amruthavalli GV, Rajagopal G. Reference of Circadian Rhythm in the Treatment of Psoriasis – A Novel Insight. Res Rev: A J Unani, Siddha Homeopathy. 2015;2(2):1–7.