In a study of 101 cases, clocortolone was shown to be highly effective in the treatment of various forms of eczema and dermatitis. Clocortolone was judged by the investigator as being effective or very effective in 71.3% of cases. It was also shown to be effective or moderately effective in most cases of psoriasis. There were mixed results in a heterogeneous group of 34 patients with other indications. Outstanding benefit was obtained in the relief of pruritus in all conditions in which this symptom occurred, and particularly in pruritus ani. Local and systematic tolerance was excellent.peer-reviewe

Agius Ferrante, Anton

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18 FENECH, F.F., MALLIA, C.P. (1972) Br. J. Dis. Chest. 60:284. FURCOLOW, M.L., (1960) Histoplasmosis (Swea-ny, H.C. Ed.), Charles Thomas p.1l3. GRA YSTON, J.T., and FURCOLOW, M.L. (1953) Amer.J.Pub.Health, 43:665. LASH, H.W. (1960), Ann. New York Acad.Sc. 89:78. MANOS, N.E., FEREBEE, S.H., and KER-SCHBAUM, W.F., (1956) Dis.Chest, 29:649. MURRAY, I.G., (1969), Personal communica-tion. PALMER, C.E., (1945), Pub.Health Depart. 60: 513. PRIOR, J.A., (1951), Amer.Rev.Tuberc. 6:538. SPITERI, L., (1973), Personal communication. TASSINARI, G., (1948), BoIl. 1st. Sieroterap.Mi-lan. 27:49. A NEW TOPICAL CORTICOSTEROID: CLOCORTOLONE CREA'M ANTON AGIUS-FERRANTE M.D. Department of Venereo~ogy and Dermatology, St. Luke's Hospita~ Clocortolone pivalate (Purantix(R) Sandoz) is a new dihalogenated cortico-steroid for topical use, 9a-Chloro-6a-fluoro-II,e, 21-dihydroxy-16a methyl-pregna-1, 4-diene-3,20-dione 21 pivalate. Its anti-inflammatory action and good tolerance have been demonstrated in animal experi-ments. In the granuloma-pouch test, its act-ivity when administered by the oral or sub-cutaneous route has been shown to be approximately thirty times that of hydro-cortisone acetate. An open clinical triai was undertaken to evaluate its efficacy and tolerance, when used at a concentration of 0.1 % in an oil-in-water base, in dermatoses normally responsive to topical corticoste-roids. . Method One hundred and one patients with the following diagnoses were treated: Psoriasis vulgaris (20) Contact dermatitis (23) Lichen chronicus simplex (9) Atopic dermatitis (6) Pompholyx (3) Seborrhoeic eczema (2) Nummular eczema (2) Pruritus in association with varicose veins (I) Infective dermatitis (I) Acne vulgaris (9) Keloid scars (8) Pruritus ani (5) Herpes simplex (I) Pityriasis rubra pilaris (I) Dermatitis papillaris capilliti (2) Fifty-three of these patients were male and forty-eight female. Only five were in-patients. Ages ranged from 3 months'to 75 years but 87 were over 14. The cream was applied two to four times daily, in con-formity with normal practice,and was con-tinued until its maximum effect was deemed to have been achieved. This averaged 26.7 days (range 8-51 days). Two patients only were treated for part of the time with occlusive dressings which were changed 3 and 7 times per week respec-19 Diagnosis Acute-weeping Acute Sub-acute Chronic Total Psoriasis vulgaris 1 9 10 20 Eczema 1 8 32 6 47 Others 4 19 11 34 TABLE I tively. Both were cases of psoriasis. Dur-ing the trial period, no other topical medicaments were applied except for potassium permanganate lotions or baths. No antibiotics or systemic steroids were administered. Assessment For the purposes of evaluation, cases were grouped into three categories, viz psoriasis vulgaris, eczema (including con-tact dermatitis, lichen chronicus simplex, pompholyx, atopic dermatitis, seborrhoeic eczema, nummular eczema, pruritus associated with varicose veins, and infec-tive dermatitis) and 'other indications' (acne vulgaris, keloid scars, pruritus ani, Effectiveness Eczema discoid lupus erythematosus, herpes sim-plex, pityriasis rubra pilaris, lichen planus, and dermatitis papillaris capilliti). Table I summarises the diagnostic distribution of the patients and the state of the lesions they exhibited. Assessment of efficacy was based on: a) recording of the following target symptoms on a four-point severity scale before and after treatment: erythema, weeping, scaling, pruri-tus, lichenification; b) overall assessments at the end of the trial by the investigator and the patients separately of efficacy on a five-point scale. Local and general side effects were also recorded. Psoriasis Other indications Physician Patient Physician Patient Physician Patient very effective 25 35 2 9 9 16 effective 21 10 7 5 8 4 moderately effective 1 2 9 4 9 8 slightly effective 1 1 3 not effective 1 1 5 6 TOTAL 47 20 34 TABLE 11 Overall Assessment ,I 20 Diagnosis Erythema Weeping Eczema 70.7% 100% (41) (10) Psoriasis 20.0% (20) Other indciations 35.7% (28) Scaling 92.3% (26) 44.4% (18) 50.0% (6) Pruritus 92.5% (40) 100% (11) Lichenifications 87.7% (7) 50.0% (2) TABLE III Percentage of Patients with Complete Regression of Symptoms Numbers in brackets refer to number of cases showing each symptom at start of trial. Results Clocortolone was judged by the inves-tigator as being effective or very effective in 71.3% of cases. It was considered moderately effective in another 18.7% and ineffective or only slightly effective in the remaining 9.9% (Table II). Target symptoms in eczema resolved completely in between 70.7% (for erythe-ma) and 100% (for weeping) of cases. Pruritus was relieved in 92.5% of cases of eczema and in 100% of the 'other indi-cations'. Average scores for target symptoms before and after treatment were calculated and the differences between pretreatment and post-treatment average scores were examined for significance by the t-test. The differences were highly significant in eczema for erythema, scaling and pruritus, and in psoriasis for both erythema and scaling (Table IV). Discussion In the eczemas, treatment was effec-tive or very effective in no less than 4:6 of the 47 cases studied. In the remaining patient, clocortolone \was 'judged moder-ately effective. In psoriasis, treatment was considered to be very effective in only 2 cases out of the 20 as judged by the investigator. Nevertheless, the improve-ment of both target symptoms was statis-tically highly significant and it is note-worthy that in the opinion of the patients the treatment was very effective in 9 cases, effective in 5 and moderately effec-tive in 4, only in one case being slightly effective and in 1 ineffective. Not un-expectedly, clocortolone proved disap-pointing in 'acne vulgaris and in keloid scars. In eight cases of keloid, treatment was moderately effective in 4, and slightly effective or ineffective in the other 4. In acne vulgaris, it was very effective in one case, effective in three cases, moderately effective in one case and slightly effective or ineffective in the remaining four. In the 5 cases of discoid lupus erythematosus, treatment was effective in 4 and very ef-fective in 1. The result in the one case of herpes simplex was assessed as very effec-tive. Of particular interest was the one case of pityriasis rubra pilaris who had been attending the clinic for 13 years and received numerous treatments without any effect but who responded rapidly and dramatically to clocortolone with com-plete resolution. The most striking ex-perience in the trial of this new product was its effectiveness in pruritic states. In all 5 cases of pruritus ani relief was com-plete, prompt and enduring although most of them were long-standing. Of the 40 cases of eczema which presented with pru-ritus, 37 (92.5%) attained complete reso-lution of this symptom. There were no general side effects in any patients. The only local side effect encountered was a mild local irritation in one patient only. 21 Average Score Diagnosis Symptom Difference t-Test Pre-treatment Post-treatment Erythema 2.0 0.3 -1.7 highly sig-nificant Weeping 1.9 0.0 -1.9 significant Eczema Scaling 1.6 0.1 -1.5 highly sig-nificant Pruritus 2.2 0.1 -2.1 highly sig-nificant Lichenification 1.7 0.1 -1.6 not signi-ficant Erythema 2.0 0.9 -1.1 highly signi-Psoriasis ficant Scaling 2.2 0.7 -1.5 Erythema 1.9 0.8 -1.1 Scaling 1.7 0.5 -1.2 not tested Other due to small Indications Pruritus 2.3 0.0 -2.3 numbers of each indica-Lichenification 2.0 1.0 -1.0 tion TABLE IV Significance of differences between pre- and post-treatment average scores. Summary In a study of 101 cases, clocortolone was shown to be highly elffective in the treatment of various forms of e1ezema and dermatitis. It was also shown to bel effec-tive 01' moderately effective in most cases of psoriasis. There were mixe1d results in a heterogenous group of 34 patients with other indications. Outstanding bene1fit was obtained in the relief of pruritus in all conditions in which this symptom oc-cUlTed, and particularly in pruritus ani. L<>ical and s)'istematic tolerance was exlcel-lent. Acknowledgement For their assistance with this study, I am grateful to Dr. J. Agius and to the sister and staff of the Outpatients' Clinic in the Department of Venereology and Dermatology at St. Luke's Hospital, Malta. I am also grateful to Sandoz Ltd. for providing the clocortolone cream and the data analysis. 

A new topical corticosteroid : clocortolone cream

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A new topical corticosteroid : clocortolone cream

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