The Efficacy of Hydrocortisone in Different Ointment Bases: A Double-Blind Study of Hydroderm vs Hydrokortison Ointments

Journal of International Medical Research, Jan 1980

A study was designed to ascertain whether hydrocortisone 1% in a recently formulated ointment base was as efficacious as a well established hydrocortisone ointment formulation. There was no difference in the results of any observed parameter. It is concluded that Hydroderm ointment base is as good as previously used vehicles. It has the additional benefit of being hypo-allergic.

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The Efficacy of Hydrocortisone in Different Ointment Bases: A Double-Blind Study of Hydroderm vs Hydrokortison Ointments

Downloaded from imr.sagepub.com by guest on October The Efficacy o f Hydrocortisone in Different Ointment Bases Knud Ludvigsen Randers Denmark Lise Hallinger Viborg Denmark A study was designed to ascertain whether hydrocortisone 1% in a recently formulated ointment base was as efficacious as a well established hydrocortisone ointment formulation. There was no difference in the results of any observed parameter. It is concluded that Hydroderm ointment base is as good as previously used vehicles. It has the additional benefit of being hypoallergic. ©Cambridge Medical Publications Limited - Introduction In order to avoid disturbing allergic reactions there is a trend to exclude inter alia lanolin and parabens from cream and ointment bases. A provision for the usefulness of new vehicles, of course, is that the efficacy of the active factor should not be jeopardized. Recently Eriksson and Enfors (1979) showed that the efficacy of hydrocortisone in an ointment free from lanolin and parabens was equal to that of the same concentration of hydrocortisone in an orthodox ointment base. Hydrocortisone in a cream base, identical to the one used for betamethasone-17 21-dipro­ pionate (Diproderrne, Diprosone", Schering Corporation) was even more efficacious than the steroid in an older cream base on the individual symptoms of scaling, pruritus and crusting in steroid responsive dermatoses. Pilgaard and Nerholm (1980) were unable to detect significant differences of the effects of two hydrocortisone creams, but proved that the action of hydrocortisone in the 'Diproderm base' was faster than its competitor. Neither Eriksson et at nor Pilgaard et at registered any side-effects with each compound. In this country the most commonly used hydrocortisone ointment is the Hydro­ kortison'" DAK. Using this compound as reference it was of interest to establish whether hydrocortisone in the same concentration in the new hypo allergic base was as efficacious. This is a report of a double-blind study designed for that particular purpose. Material and Methods Sixty-one patients with steroid responsive dermatoses, the diagnoses of which are given in Table 1, were allocated to one of the thera­ peutic alternatives according to a double-blind randomized system. Thirty patients received the new ointment base with 1% hydro­ cortisone (provisional name = Hydroderm, Schering Corporation), and thirty-one patients Distribution of diagnoses Hydrokortison DAK Atopic dermatitis (Prurigo Besneir) Contact eczema allergic Eczema nummeJatum Eczema seborrhoicum (pityriasis) Lichen ruber Other eczema Hydrokortison DAK Sex distribution Age distribution Total duration of dermatitis Status prior to initial visit Much better Slightly better No change Slightly worse Much worse Table 6 Patient's overall evaluation after 3 weeks DAK received Hydrokortison DAK. The sex and age distributions are given in Tables 2 and 3. The comparability of the two therapeutic groups was established by the distribution of charac­ teristics of the individual patients, as shown in Tables 4 and 5. Much better Slightly better No change Slightly worse Much worse Inflammation Knud Ludvigsen and Lise Hallinger Investigator's overall evaluation after 3 weeks Hydroderm symptom for each stage of the observation period. Statistical evaluation was made accord­ ing to generally accepted principles. Difference between means was calculated according to the formula Xl - x2' where SEdiff =the standard SEdiff error of the difference between the means Xl and x2 (Swinscow 1976), p <0·05 was accepted as significant. Results The patient's and the investigator's overall impressions of the state of the disease are shown in Tables 6 and 7. After three weeks of treatment the rates of improvement after Hydroderm were 83% (patient's evaluation) and 80% (doctor's evaluation), respectively. After Hydrokortison DAK the corresponding figures were 90% and 90%, respectively. The difference was not significant. The effects on the individual symptoms are illustrated in Table 8. Neither after one nor three weeks was there any significant difference between the outcome of the two treatments for any recorded sign or symptom. The remarkable concordance of the average scores already after the first week indicates that also the rapidity of the onset of action was similar. Effects on individual symptoms of two hydrocortisone ointments Treatment A verage score Difference between treatments Discussion The initial similarity between the two thera­ peutical groups was striking (Tables 1-5 and Table 8, column 3) and we feel that a comparison was well justified. The results both of overall evaluation by patient and doctor, and of the individual symptoms proved that both formulations were highly effective, and that there was no difference between them. Thus, it was shown that Hydroderm was equally efficacious as Hydrokortison OAK. Our results agree with those by Eriksson and Enfors (1979), who found Hydroderm ointment 1% to be equal to Hydrocortisone ACO ointment 1%, which as in the case of Hydrokortison OAK contains propylene glucol, cetanol, paraffin oil and vaseline. Efficacy being similar the choice between two ointments must be dictated by other parameters. One of the most important of those is the allergic potency of the vehicle. Very few investigations with Hydroderm are published, but a comparison with the vehicle used for the considerably more potent steroid, betamethasone dipropionate, can be made. The Hydroderm ointment base is identical to that of Diproderm ointment. The side-effects of the latter compound were reviewed by Chambers, Cash and Marinaccio (1976) who summarized that the overall incidence of side­ effects for Diproderrn was 5·8% and for all other steroids combined 7·4%. The reported side-effects were typical of those reported for topical steroid preparations. Thus, it appears that the vehicle of Diproderrn and Hydroderm is a safe compound and little inclined to cause allergic manifestations. The rate of side-effects in this series was nil, as in the reports by Eriksson et al and Pilgaard et al, giving support to this assumption. REFERENCES Chambers W B, Cash W S & Marinaccio A (I976) Diprosone (betamethasone dipropionate) cream 0·05%. Review and report of a multicentre study. Journal of International Medical Research 4, Suppl (3), 1 Eriksson G & Enfors V (I979) A double-blind comparative clinical study of Hydrocortisone Schering acetate ACO cream 1% and Hydrocortisone ACO ointment 1%. Internal report, Schering Corp, Kenilworth, USA Pilgaard C E & Njrholm A (1980) Hydrocortisone in an improved vehicle. A double­ blind comparison of the efficacy and acceptability of two hydrocortisone cream formulations. Journal of International Medical Research 8, 81 Swinscow T D V (I976) Statistics at square one. British Medical Associ­ ation. London


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Knud Ludvigsen, Lise Hallinger. The Efficacy of Hydrocortisone in Different Ointment Bases: A Double-Blind Study of Hydroderm vs Hydrokortison Ointments, Journal of International Medical Research, 1980, 77-80, DOI: 10.1177/030006058000800113