Diprosone Ointment in Psoriasis

2030 S.A. MEDICAL JOURNAL 5 October 1974 10. (a) Seminar on Fenfluramine and Obesity (Nassau. Bahamas) (1971): 15. Pawan, G. L. S. (1969): Lancet, I, 498. S. Afr. Med. 1.. 45, supp!. 19 June. 16. Munro, J. F., Seaton, D. A. and Duncan, L. J. P. (1966): Brit. (b) Symposium on Fenfluramine and Derivatives (Marbella, Spain) Med. J .. 2. 624. (1974): Postgrad. Med. J. (10 press). 17. Drug and Therapeutics Bulletin (1970): 8, 21. 11. Sapeika, N. (1973): Centr. Afr. J. Med.. 19.23. 18. Leading Article (1974): Brit. Med. J., I, 168. 12. Waal-Manning. H. J. and Simpson, F. O. (1969): Lancet, 2, 1392. 19. Oswald, I.. Lewis. S. A., Dunleavy, D. L. F., Brezinova, V. and 13. General Practitioner Clinical Trials (1971): Practitioner. 207, 101. Briggs. M. (1971): Ibid., 3, 70. 14. Lewis, S. A .. Oswald, 1. and Dunleavy, D. L. F. (1971): Brit. Med. 20. British Medical Association (1974-16): Brilish Nmional Formulary. J .. 3. 67. London: Pharmaceutical Press. Diprosone Ointment In• Psoriasis A DOUBLE-BLIND TRIAL C. M. ROSS SUMMARY responding poorly to other forms of treatment, a situation only too frequently encountered. A double-blind trial which compared the effects of two Betamethasone dipropionate has the chemical formula topical steroids on 58 successive cases of psoriasis is 9-fluoro-16- J1-methylprednisolone-17, 21-dipropionate. As reported. The investigations compared the efficacy and shown by the Stoughton-McKenzie vasoconstrictor res cosmetic acceptability of betamethasone dipropionate oint ponse test,' it is effective at a concentration of 0,000016%, ment (Diprosone) with that of fluclorolone acetonide oint which is lower than that of any other steroid so tested.' ment (Topilar). The Stoughton-McKenzie test is used as a measure of Under the conditions of the trial, the betamethasone the activity of locally applied steroid preparations, and dipropionate ointment in a concentration of 0,05% was the figure obtained indicates that Diprosone is an extreme significantly superior to 0,025% fluclorolone acetonide oint ly active preparation. ment in both the patient's over-all evaluation (P<O,024) and in the investigator's over-all evaluation (P<O,OOB); in the relief of pruritus noted by the patient (P<O,063) and PATIENTS AND METHODS in the degree of improvement in scaling observed by the investigator (P<0,080). Patient Selection The phenomenon of sweating in patches of psoriasis is discussed. Fifty-eight successive patients with psoriasis were studied; 30 were treated with Diprosone and 28 with S. Air. Med. l., 48, 2030 (1974). Topilar. The majority of the patients (33) had had psoriasis for over 5 years and the condition was either Topical corticosteroids are firmly established as the first static or exacerbating slowly. Of these patients, 50 had line of treatment for inflammatory dermatoses. Never received prior therapy either with Synalar or with Betno theless, no preparation yet available is completely effective vate ointment, with no more than temporary benefit. and the search for better agents continues. This is No pregnant or lactating females and no patients with particularly true of psoriasis. It can well be said that the viral or tuberculous skin infections were included in the discovery of any loca! application that would regularly trial. No other local applications, no oral steroids and relieve or even consistently improve that recalcitrant no oral antihistaminics were permitted during the trial, disorder would constitute a major therapeutic advance. and none of the patients had been on them for at least a The preparation reported on in this trial (Diprosone) is week before the trial. still not the long sought-after panacea. The findings, however, show that it is highly active and cosmetically acceptable, and that a high percentage of patients treated Study Design do show improvement while it is in use. Diprosone is therefore worth prescribing for any patient with psoriasis The patients were assigned at random in double-blind. Department of Dermatology H. F. Verwoerd Hospital, fashion to product A (Diprosone) or to product B Pretoria (Topilar). Both preparations were supplied in 40-g tubes C. M. ROSS, M.B. CH.B., LR.C.P. of identical appearance. The patients were instructed to Date received: 11 April 1974. apply the ointrpents twice daily, once in the morning 5 Oktober 1974 S -A. MEDIESE TYDSKRIF 2031 and once in the evening, and to massage them in lightly. Statistical analysis shows that under the conditions Plastic occlusion was not used. pertaining to this trial, Diprosone was significantly su The patients were kept under observation for three perior to Topilar in both the patient's evaluation (P< successive weeks, and were re-examined by the same 0,024) and the investigator's evaluation (P<0,008), and observer at weekly intervals during the trial. Their response in the degree of improvement in scaling (P<0.080) and was evaluated in respect of the relief of pruritus and in pruritus (P<0,063). the disappearance of induration, inflammation (shown by redness), crusting and scaling. Side-Effects Pruritus is a subjective symptom. The assessment of its severity and any degree of improvement is dependent There were 3 patients with side-effects from each drug. on the patient's comments, although the presence or Two patients treated with Topilar complained of burning absence of scratch marks and bleeding points may guide and 1 developed a boil on the right knee. One patient the observer. It is sometimes thought that pruritus is not on Diprosone developed pustules in the scalp, I de a prominent feature of psoriasis. This is by no means so. veloped boils on the right leg and I developed transient, Lesions in many situations, in particular on the scalp, in clear, superficial bullae on a sun-exposed area. the flexures and on the lower legs, may itch intolerably. A preparation's ability to relieve this symptom is con sequently of value in assessing its usefulness. DISCUSSION Scaling is the end result of abnormal keratinisation. Its diminution, or in greater degree its control, is a The nature of the bullae seen in the patient treated with visible indication that the preparation in use is modifying Diprosone remains uncertain, but for the reasons given the excessive cell turnover and disordered granular layer later, the fact that bullae appeared was taken to indicate formation characteristic of the disease. that the preparation was therapeutically active. It was not At the final visit, the findings of the investigator and looked upon as an undesirable side-effect. the comments of the patients in respect of all the para The absence of sweating in patches of psoriasis which meters were taken into account, and an over-all assess are not responding to treatment or which have not been ment was made. The results were classified as much treated; and the resumption of sweating in areas which better, slightly better, no change, slightly worse or much have been cleared, are well-recognised phenomena. Shuster worse, and were evaluated statistically by the technique and Johnson' and Johnson and Shuster' have shown that of non-parametric statistical inference." there are two abnormalities of sweat gland function in the Analysis of the data was carried out via the non plaques of psoriasis: (i) superficial obstruction of the parametric WiIcoxon two-sample test. ducts leading to hypohydrosis; and (ii) an abnormality of absorption by the duct leading to inappropriately low sweat electrolyte concentration. RESULTS They were able to remove the duct blockage by complete cellophane stripping, and thereafter the sweat Table I summarises the over-all findings of the trial. rate in the plaques of psoriasis was significantly greater than the rate in stripped clinically normal skin between TABLE I. OVER-ALL EVALUATION the plaques. They concluded that this indicated a second Diprosone Topilar defect in sweat gland function in the plaques; either an increased rate of secretion by the coil or a decreased rate Patient's Doctor's Patient's Doctor's of absorption by the duct. They proposed that miliaria evaluation evaluation evaluation evaluation occurred when the capacity of the coil to secrete was Worse 0 0 0 0 greater than the ability of the duct to absorb, and they No change 1 2 0 1 noticed with surprise their inability to produce miliaria Slightly better 5 5 14 17 in stripped psoriasiform plaques after stimulation with Much better 24 23 14 10 pilocarpine in cases in which their findings showed im paired ductal absorption of water in relationship to Na+, K +, urea and possibly lactate. They concluded that this The significant contrasts are given In Table 11. indicated that the capacity for ductal absorption, though impaired, still exceeded the rate of coil secretion. TABLE 11. SIGNIFICANT CONTRASTS (P<0,10j If miliaria occur after the removal of psoriasiform scales by Diprosone, this may indicate one of three In favour of possibilities. Firstly, the clearing of the duct blockage may Parameter Visit P value D:prosone Topilar be more complete than that produced by stripping. Patients' over-all Secondly, in addition to removal of the blockage, the evaluation F:nal 0,024 X Diprosone may stimulate secretion by the coil, and third Investigator's over-all ly, the Diprosone may interfere with and thus reduce evaluation Final 0,008 X ductal absorption. A circumstance or set of cirumstances Scaling Final 0,080 X could therefore have resulted in which secretion was Pruritus Final 0,063 X greater than absorption, and which led, in consequence, No other significant differences could be shown to exist (P<O,10). to the formation of miliaria. 2032 S.A. MEDICAL JOURt AL 5 October 1974 It is thought on morphological grounds that the buIlae Both Diprosone and Topilar were criticised by the were lesions of miliaria crystallina.

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