The Efficacy of Hydrocortisone in Different Ointment Bases: A Double-Blind Study of Hydroderm vs Hydrokortison Ointments
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The Efficacy o f Hydrocortisone in Different Ointment Bases
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
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
Atopic dermatitis (Prurigo Besneir)
Contact eczema allergic
Eczema seborrhoicum (pityriasis)
Total duration of dermatitis
Status prior to initial visit
Patient's overall evaluation after 3 weeks
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.
Knud Ludvigsen and Lise Hallinger
Investigator's overall evaluation after 3 weeks
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
error of the difference between the means Xl
and x2 (Swinscow 1976), p <0·05 was
accepted as significant.
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
Effects on individual symptoms of two hydrocortisone ointments
A verage score
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.
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),
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