A Clinical Comparison of Betamethasone 17,21-Dipropionate and Clobetasol Propionate Creams in Dermatology

Journal of International Medical Research, Mar 1977

In a double-blind investigation, 36 patients suffering from various steroid-responsive dermatoses were treated twice daily for three weeks either with 0·05% betamethasone 17,21-dipropionate cream or with 0·05% clobetasol propionate cream. Results showed both products to be highly effective in terms of onset of action and efficacy and no statistical differences were found (p > 0·1).

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A Clinical Comparison of Betamethasone 17,21-Dipropionate and Clobetasol Propionate Creams in Dermatology

V Voigtlnder 0 1 M D 0 1 Dermatology 0 1 0 Diprosone, Diproderm, Schering Corporation U.S.A. Dermovate, Dermoxin, Glaxo Limited U.K 1 Clinic, University of Heidelberg In a double-blind investigation, 36 patients suffering from various steroidresponsive dermatoses were treated twice daily for three weeks either with 0 - 0 5 % betamethasone \1,2\-dipropionate cream or with 0 - 0 5 % clobetasol propionate cream. Results showed both products to be highly effective in terms of onset of action and efficacy and no statistical differences were found (p > 0 1). - Introduction Since the introduction of topical corti costeroid therapy into dermatological practice over twenty years ago, there have been many advances and now a wide range of potent products is available. Although of course all corticosteroids have limitations in use, it is nevertheless of interest to investigate new preparations in the search for a product of optimal profile. The two preparations tested here are both new and have been developed specifically for dermatological use. Betamethasone dipropionate* has the chemical structure 9afluoro-16-methylprednisolone-17,21 -dipropionate and has been shown by the McKenzieStoughton vasoconstrictor technique to be 3-6 times more active than the 17-valerate ester of betamethasone, which in turn is 3-6 times more active than fluocinolone acetonide usually taken as the standard vasoconstrictor substance (McKenzie & Stoughton 1962, McKenzie 1966, Viglioglia 1972). Clobetasol propionate** is also a derivative of betamethasone: 21-chloro-9a fluoro-16-methyl prednisolone-17-propionate, and has a vasoconstriction index of 18-7, slightly higher than betamethasone dipropionate's 13-0 (Sparkes & Wilson 1974). Both betamethasone dipropionate (Pallagrosi 1975, Chambers, Cash & Marinaccio 1976, Giard & Pons 1974, Chamey & Leibsohn 1975, Hersle & Mobacken 1975, Wortzel 1975) and clobetasol propionate (Sparkes & Wilson 1974, Woodbridge 1974, Lassus 1976, Bjrnberg & Hellgren 1975) have been tested clinically and have been found to be highly effective in the treatment of a variety of steroid-responsive conditions. However, the only report comparing the two preparations was of a study on efficacy under occlusive dressings (Lassus 1976) and one cannot necessarily extrapolate the findings to normal use. The objective of this investi gation was to compare the two preparations in normal twice daily use without occlusive dressings. Materials and methods Betamethasone dipropionate 0 0 5 % cream and clobetasol propionate 0 - 0 5 % cream were supplied in identical plain white tubes labelled only with a patient number according to standard randomized double-blind methods. Only at the end of the investigation was the code broken to determine which patient had received which preparation. Patients The study included a total of 36 patients 35 male and 1 female ranging between 15 and 76 years (average 43-2 years), all of them out-patients at the University Dermatology Clinic. They presented with various inflam matory skin conditions amenable to treatment with topical corticosteroids. Table I shows the distribution of indications, all of which had been manifest for one month or longer. All but one had previously tried various topical corticosteroid preparations. Candidates with tuberculosis of the skin, whether active or latent, viral infections of the skin, vaccinia and varicella, together with pregnant or lactating women, were excluded. Investigation At the initial visit, all patients were thoroughly examined and comprehensive details were recorded on specially designed case report forms. The patients were instructed to apply the medication provided twice daily and under no circumstances to use occlusive dressings or concomitant medication. They returned at seven day intervals (more Types and numbers of the treated dermatoses Contact dermatitis Dyshidrotic eczema Statis eczema Chronic eczema of the hand (tylotic-rhagadiform type) Eczematous drug exanthema Nummular eczema Lichen simplex chronicus Vidal frequently in a few serious cases) until the end of the three week investigation. Apart from overall disease status, amelioration of induration, inflammation, crusting, scaling, pruritus, excoriations and pain were recorded, together with any unusual observations or side-effects. Any patient who did not return or who did not follow exact instructions was eliminated from the trial and replaced. Results were analyzed for statistical signifi cance using the well established MannWhitney U method. The rapidity of action of the two preparations was measured by observation of initial improvement in the subjective signs and symptoms described in the previous section. The results for both treatment groups are shown in Table 2. As can be seen, both preparations acted very rapidly; 30 patients (83%) noticed the onset of action within 48 hours following the first application. There were however no statistical differences ( > 0 1 ) detected between the two treatment groups. Efficacy Overall efficacy as evaluated at the end of the three week treatment period was very good for both preparations. Again, there were no statistical differences in any of the para Treatment group Betamet/iasone dipropionate Clobetasol propionate Onset of action 0-24 hours 24-48 hours 48-72 hours Over 72 hours Treatment result Results: the rapidity of onset of action of the two tested preparations Results: overall efficacy at the end of the trial period The Journal of International Treatment group Betamethasone dipropionate Clobelasol propionate Treatment group Betamethasone dipropionate Clobetasol propionate meters evaluated. Detailed results are seen in Table 3. The indication least responsive to treatment proved to be chronic tylotic-rhagadiform eczema of the hand, an understandably difficult condition. By chance, all five cases fell in the betamethasone dipropionate group making a comparative evaluation impossible and perhaps weighing betamethasone dipro pionate somewhat unfairly in the overall evaluation. Tolerance and cosmetic acceptability Both preparations were tolerated very well and no patient showed any sign of contact sensitization. One patient in the beta methasone dipropionate group complained of a slight burning at the site of application during the last two days of treatment. Also, one patient in the clobetasol propionate group showed signs of skin atrophy after two weeks of treatment in the area of the left popliteal fossa. This effect can, however, be explained by the patient's use a of rubber knee cap which had the same effect as an occlusive dressing. Discussion and conclusions This three-week double-blind study showed betamethasone dipropionate and clobetasol propionate to be equally effective in the treat ment of steroid-responsive dermatoses. In terms of efficacy, onset of action and tolerance, no statistical differences were detected. However, it is important to bear in mind the limitations of any short-term closely controlled clinical trial such as this. A well defined clinical profile of indications, limita tions, efficacy and safety can only be arrived at after very extensive general availability over several years. This is particularly the case with safety and some side-effects may only become a p p a r e n t after widespread use. It is of course well known t h a t topical steroids potent drugs a n d caution t o avoid local or systemic side-effects. commercially available products, however, have been well tried a n d are safe if used carefully. publications methasone dipropionate have now appeared, a detailed search of the literature failed to reactions different from any other similar preparation a n d it is therefore likely t h a t it's profile is a number of important publications have now appeared on significant side-elfects of clobeta sol propionate (Boxley et al reactions precipitation of generalized pustular psoriasis et al 1975, T a n 1974), iatrogenic Cushing's syndrome (Staughton 1975) a n d hypothalamicpituitaryadrenal axis suppression (Ortega et al 1975, Feiwal & 1974, T a n Clobetasol p r o p i o n a t e does, therefore, appear to be an extremely potent steroid which is rather readily absorbed. I n fact a recent study al (1975) recommends maximum dosage of 50 grams In these respects, it would seem that clobetasol p r o p i o n a t e behaves rather differently other topically applied corticosteroids. Allenby C F, et al (1975) Effect on adrenal function of topically applied clobetasol propionate (Dermovate). British Medical Journal 4, 619 Bjrnberg A & Hellgren L (1975) Treatment of psoriasis with clobetasol propion ate: a double-blind comparison with betamethasone valerate. Current Medical Research and Opinion 3 , 36 Boxley J D, et al (1975) Generalized pustular psoriasis on withdrawal of clobetasol propionate ointment. British Medical Journal 2, 255

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V Voigtländer. A Clinical Comparison of Betamethasone 17,21-Dipropionate and Clobetasol Propionate Creams in Dermatology, Journal of International Medical Research, 1977, 128-131, DOI: 10.1177/030006057700500210