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Clobetasone Butyrate, a New Topical Corticosteroid: Clinical Activity and Effects on Pituitary-Adrenal Axis Function and Model of Epidermal Atrophy

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Clobetasone Butyrate, a New Topical Corticosteroid: Clinical Activity and Effects on Pituitary-Adrenal Axis Function and Model of Epidermal Atrophy 626 BRITISH MEDICAL JOURNAL 13 SEPTEMBER 1975 17 Anderson, J. R., Goudie, R. B., and Gray, K. G., British J7ournal of 21 Temple, R., et al., Mayo Clinic Proceedings, 1972, 47, 872. Experimental Pathology, 1960, 41, 364. 22 Carlson, H. E., Temple, R., and Robbins, J., Journal of Clinical Endo- Br Med J: first published as 10.1136/bmj.3.5984.626 on 13 September 1975. Downloaded from 18 Fulthorpe, A. J., et al., Journal of Clinical Pathology, 1961, 14 654. crinology and Metabolism, 1973, 36, 1251. 19 Holborow, E. J., et al., British J7ournal of Experimental Pathology, 1959, '3 Cotton, G.. E., Gorman, C. A., and Mayberry, W. E., New England 40, 583. Journal of Medicine, 1971, 285, 529. 20 Evered, D. C., et al., British Medical.Journal, 1973, 1, 657. 24 Utiger, R. D., Journal of Clinical Investigation, 1965, 44, 1277. Clobetasone Butyrate, A New Topical Corticosteroid: Clinical Activity and Effects on Pituitary-Adrenal Axis Function and Model of Epidermal Atrophy D. D. MUNRO, LYN WILSON British Medical Journal, 1975, 3, 626-628 Studies THE DRUG Summary ClobetasQne butyrate is 21-chloro-11 dehydro betamethasone 17- butyrate. It was selected for study because screening tests indicated a Clobetasone butyrate is a new corticosteroid, selected separation of topical from systemic activity. The comparative values for study because of its combitation of good activity in for topical and systemic activityl of clobetasone butyrate and five the vasoconstriction test and low systemic activity in other steroids are given in the table (in arbitrary units). animals. Formulated as an 005o% ointment and cream (MolivateN it was clinically effective in patients with Comparative Topical (Vasoconstriction) and Systemic (Thymus Involution) eczema, its activity being significantly greater than that Activities of Six Corticosteroids of hydrocortisone 1% or fluocortolone 020°, (Ultradil). that to maximal percutan- Under conditions predispose Vasoconstriction Thymus Involution eous absorption clobetasone butyrate ointment had Corticosteroid Activity* Activityt minimal effect on hypothalamic-pituitary-adrenal func- Betamethasone alcohol 0 8 100 an animal model of cutaneous atrophy it caused Fluocinolone acetonide 100 225 tion. In Betamethasone valerate 360 170 less thinning of the epidermis than steroids other than Betamethasone behzoate 345 829 hydrocortisone. ointment and Clobetasol propionate 1869 636 ClobetasonebutyrateO.05% Clobetasone butyrate 263 9 http://www.bmj.com/ cream gave every indication of offering clinically effec- tive topical anti-inflammatory activity with a wide *On intact human skin. margin of safety. tSubcutaneously in the mouse. Introduction EFFECTIVENESS IN ECZEMA AND PSORIASIS That medicaments can be absorbed through the skin has been The topical anti-inflammatory activity of clobetasone butyrate was known for a long time. While this route is usually of little studied in a series of trials involving 409 patients with eczema. The on 24 September 2021 by guest. Protected copyright. significance percutaneous absorption of potent compounds can steroid was formulated as a bland cream, without the addition of ointments penetrants such' as propylene glycol. Patients had bilateral, approxi- be important. The application of corticosteroid and mately symmetrical lesions to which the test and control preparations creams only permits an approximate dosage per unit area. An were allocated randomly; thus the patients acted as their own controls. alternative approach is to use a range of steroid preparations All the trials were double blind, using the method described by of differing potency, so that an appropriate strength may be Williams et al2 Occlusive dressings were not used. Clobetasone selected, depending on the diagnosis or severity of the disease. butyrate was tested in increasing concentrations of 0-01%, 0-0250,/ The prolonged application of any potent corticosteroid may and 0.050/O against hydrocortisone 1 % cream. lead to atrophic skin changes and there is a risk of at least The results of these dose response trials are shown in fig. 1. Clobeta- transient suppression ofhypothalamic-pituitary-adrenal (H.P.A.) sone butyrate at 0-01% was similar to hydrocortisone 1%, at 0 025% function. Thus, a corticosteroid with greater topical anti- it was rather more effective, and at 0 05°,, it was significantly more but lesser effective (P <0 05). inflammatory activity than hydrocortisone potential Though clobetasone butyrate 0 05% was not envisaged as being a for inducing side effects than the more potent compounds is primary treatment for psoriasis, which normally responds adequately needed. We describe here studies performed with a new glu- only to the more potent steroids, we thought it appropriate to confirm cocorticoid-clobetasone butyrate-to investigate its anti- the findings in eczema in patients with psoriasis. Differences in the inflammatory activity and effect on H.P.A. function in patients relative activity of topical steroids are more readily shown in psoriasis,3 with skin diseases. The use of an animal model to assess atrophic and hydrocortisone has little effect. Twelve patients with psoriasis potential is also described. were studied in a double-blind trial, usingclobetasonebutyrateO05% inasimple paraffinointment base underocclusive dressings. Ten patients responded better to the clobetasone butyrate and two to the hydro- cortisone ointment. Though the new steroid was more effective than St. Bartholomew's Hospital, London ECIA 7BE hydrocortisone, the psoriasis did not respond to it as well as would D. D. MUNRO, M.D., F.R.C.P., Consultant Dermatologist have been expected had the condition been treated with betamethasone Glaxo Laboratories Ltd, Greenford, Middlesex valerate or clobetasol propionate. Research Unit Head The activity of clobetasone butyrate 0 05",, cream and ointment LYN WILSON, M.P.S., Clinical was further investigated in double-blind comparisons withfluocortolone BRITISH MEDICAL JOURNAL 13 SEPTEMBER 1975 627 normal in the other three. The urinary oxogenic steroid levels, though 80 Equal response a little reduced during treatment in four patients, were not significantly Br Med J: first published as 10.1136/bmj.3.5984.626 on 13 September 1975. Downloaded from Better response to 1%hydrocartisone I.S.T. and 70 different from pretreatment values. The pretreatment * Better response to clobetasone butyrate S.T.T. results were normal. The results (I.S.T.) after treatment were * P<005 60 abnormal in three cases, though only marginally so in two of them. ... The second group comprised three patients treated with clobetasone 'p 50 butyrate 0-05°/ ointment (Molivate). Two patients had atopic eczema 0 affecting 10000 and 900% of body surface, and the third had con- a. 40 stitutional eczema covering 6000. All pretreatment and posttreatment I.S.T. and S.T.T. results were normal. The third patient showed no 30 variation in daily plasma corticosteroid levels during active treatment. In the patient affected over 90% of his body surface the plasma and 20 urinary corticosteroids remained within normal limits though there 10 were minimal falls of both levels in the middle of treatment (fig. 3). The remaining patient had similar mid-treatment falls but to a greater 0 levels recovered while treatment .001% 0025% 0C degree. In both these patients the Concentration of clobetasone butyrate continued. All three patients responded to treatment and their skin was free of rash by the end of the study. Healing was slower than might FIG. I-Comparative response of patients with bilateral have been expected with more potent corticosteroids. eczema to hydrocortisone l % and clobetasone butyrate creams. o Equol response ATOPIC ECZEMA 900/o surface * Better response to fluocortolone * Better response to clobetasone butyrate 300- * P<o0 i, * 25 O 200 _ 20 c 100 - I 5 50 - d Z 10. 40 3020'- 5, 10- 0 0 0 5 10 Cream Ointment Days FIG. 2-Comparative response of patients with bilateral FIG. 3-Plasma corticosteroid and urinary oxogenic eczema to fluocortolone 0-2° (Ultradil) and clobeta- steroids before, during, and after treatment with sone butyrate 0-05% (Molivate). clobetasone butyrate 0-05%0 ointment under polythene occlision in one patient. Conversion: SI to Traditional Units-Plasma http://www.bmj.com/ corticosteroids: lttg/l -= Oltg/100 ml (normal range 60- pivalate and hexanoate ointment and cream 0 20/. (Ultradil) in patients 220 gg/l). Oxogenic steroids: 1 tLmol/24 h 0-29 h. with bilateral eczema. Occlusive dressings were not used. The lesions sg/24 treated with clobetasone butyrate responded better than those treated with fluocortolone (fig. 2), and the difference between the two oint- EFFECT ON EPIDERMIS ments was statistically significant (P <0 01). A method of inducing epidermal thinning in pigs by the application of corticosteroids has been described by Winter and Wilson. 5 The on 24 September 2021 by guest. Protected copyright. EFFECT ON H.P.A. FUNCTION formulated steroidal compounds were applied to the shaved dorsal skin of the large white domestic pig. Standard quantities packed in The effect of percutaneously absorbed betamethasone valerate on coded identical tubes were spread under occlusive dressings on five H.P.A. function has been described,4 and several other corticosteroids days of each week for seven weeks. Unmedicated ointment or cream have been studied similarly (D. D. Munro, unpublished data). The base and hydrocortisone 100 were used as controls. Biopsies were effect of percutaneously absorbed clobetasone butyrate on the H.P.A.
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