J Int Med Res (1981) 9,152

A Randomized, Controlled Clinical Trial of Four

Anti-Dandruff Shampoos

Marvin Rapaport, MD, School of Medicine, Department of Dermatology, University of

California at Los Angeles (U.CL.A.), Los Angeles, California, U.S.A.

A total of 199 patients were selected for a comparison of the anti-dandruff

efficacy of four shampoos. After a 2-week lead-in (all patients used only
Johnson's Baby Shampoo twice weekly) the patients were randomly assigned
to Selsun Blu~, Head & Shoulderss, Flexe; or Tegrine. The test
preparation, which was unknown to the observer, was used twice weeklyfor 4
weeks. Loose and adherent dandruff were each rated on a scale of 0 to 20
(absent to severe) at the end of the lead-in (when a total score of 15 was
required), and each week of study. The mean total pre-study score for all
subjects was 19·5. At the end ofthe study the mean improvement scores were:
16·2 (Selsun Blue), 14·6 (Head & Shoulders), 13·5 (Flex), and 13·1
(Tegrin). The improvement was significantly greater (p < 0·05) on Selsun
Blue than on any of the other shampoos. At the end of the study significantly
(p < 0·05) more patients had total scores ofzero on Selsun Blue (15) than on
Tegrin or Head & Shoulders. In addition, the rate of improvement was
significantly (p < 0·05) faster with Selsun Blue than with any ofthe other test
preparations.

Introduction pyrithione, and coal tar derivatives in

Dandruff is a chronic, non-inflammatory scalp
condition characterized by excessive scaling
(Ackerman & Kligman 1969). Estimates of its
prevalence range up to 70% of the population
(Bourne & Jacobs 1956, Roia & Vanderwyk
1969).
There is no known cure for dandruff, only
control of the condition. Cleaning the hair and
scalp frequently, perhaps daily, often is
sufficient. Non-prescription anti-dandruff
preparations contain specific ingredients to
better control the condition with less frequent
shampooing. Among the most commonly used
ingredients are selenium sulfide, zinc
combination with allantoin.
Although many studies have been
conducted to assess the efficacy of these
ingredients (Kligman et al 1974, Kligman,
McGinley & Leyden 1976, Orentreich et al
1969), none has directly compared
commercially available non-prescription
products containing these ingredients in a
randomized, controlled design. The present
study was performed to accomplish that goal.
Accordingly, at weekly intervals, the
efficacy of selenium sulfide 1% (Selsun Blue,
Abbott Laboratories) was compared with
two zinc pyrithione preparations (Head &

0300-0605/81/020152-05 $02·00 ©Cambridge Medical Publications Limited

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Marvin Rapaport 153

Shoulders, Procter and Gamble; and Flex
Balsam and Protein Anti-dandruff Shampoo,
Revlon), and a coal tar extract - allantoin
combination product (Tegrin Medicated
Shampoo, Reedco).
Materials and Methods
Johnson's Baby Shampoo, for use during the
lead-in period, was supplied in 7-ounce
containers as marketed by the manufacturer.
The four test preparations were supplied in
identical 12-ounce plastic bottles. Each of
these containers was labelled with the patient's
number, instructions for use and appropriate
precautionary information.
In accordance with the provisions of the
protocol, 199 patients were selected for study.
All of them were in good general health with
no skin disorders, other than dandruff. None
had open lesions, crusts or excoriations on
the scalp, and none had a history of adverse
reactions to the active ingredients of any of the
test preparations (i.e., selenium sulfide, zinc
pyrithione, coal tar, or allantoin). Female
patients taking oral contraceptives had been
taking the same preparation for at least 6
weeks, and no change was anticipated during
the 6-week course of the study. Each patient
agreed not to swim during the course of the
study, and each patient voluntarily signed a
statement of informed consent prior to
admission to the study.
The study was separated into two segments.
During the first segment, of 2 weeks' duration,
each patient used Johnson's Baby Shampoo
twice weekly. No other shampoo or hair
preparations (e.g., conditioners, colouring
products, and sprays) were used during this
period. @ At its conclusion each patient was

Table 1
Description of patients

Test preparation

Selsun Blue Head & Shoulders Flex Tegrin Total

Sex:
Male 16 15 15 15 61
Female 34 34 35 35 138

Age:
16-20 8 4 2 2 16
21-30 20 16 22 21 79
31-40 12 18 16 16 62
41-50 5 8 6 7 26
> 51 5 3 4 4 16

Race:
White 38 40 35 31 144
Black 7 3 8 8 26
Oriental I 5 4 9 19
Spanish 4 I 3 2 10

Scalp condition:
Normal 16 19 20 18 73
Oily 18 18 19 24 79
Dry 16 10 11 8 45
Not reported 0 2 0 0 2

Shampoo frequency:"
< 2/week 8 5 12 5 30
2/week 17 23 22 18 80
> 2/week 24 20 15 24 83
Not reported I 1 I 3 6

-Frequency of shampooing prior to study

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154 The Journal ofInternational Medical Research

again seen and the dandruff was evaluated.
Loose dandruff was scored on a scale of 0 to
20. Similarly, adherent dandruff was rated on
a scale of 0 to 20, and a total score (loose plus
adherent) of at least 15 was required for
admission to the comparative segment of the
study.
The second segment was of 4 weeks'
duration. On admission each patient was
randomly assigned to one of the four test
preparations by means of a computer-
generated series of random numbers. The test
shampoo was used twice weekly, but no other
hair preparations were used during this phase
of the study. Each patient was seen at weekly
intervals (4 days after the preceding shampoo)
when the severity of loose and adherent
dandruff was scored by the investigator as it
had been scored at the end of the lead-in
period.
Results
1. Description ofPatients
A total of 199 patients entered the study and
were randomly separated into four treatment
groups. These treatment groups are compared
in Table 1.
There were no clinically significant
disproportions among the four groups with
randomization resulting in clinically
comparable treatment groups. Most of the
patients (69%) were female, and most of them
(72%) were white. Relatively few patients
(29%) were less than 21 or more than 40 years
of age. Most patients (76%) had scalp
conditions characterized as normal or oily,
and most of them (85%) shampooed their hair
twice a week or more frequently prior to the
study.
Five of 199 patients (3%) failed to complete
the course of the study. Three of them,
randomly assigned to Selsun Blue Shampoo,
failed to return for follow-up. Two others,
assigned to Head & Shoulders Shampoo,
also failed to complete the study. One of them
used a hair spray in violation of the protocol,
and the other was found to be 16 years of age,
less than the minimum (18) specified by the
protocol for participation in the study. Both of
them were withdrawn from further study.

Table 2
Number of patients with ICores ofzero at each visit

Week ofstudy"

1 2 3 4

Selsun: n =44 n =45 n =44 n =47

Loose dandruff 0 8 8 16
Adherent dandruff 4 15 18 30
Total dandruff 0 7 6 15

Head & Shoulders: n=45 n =45 n =44 n =47

Loose dandruff 0 2 3 10
Adherent dandruff 9 14 13 21
Total dandruff 0 1 3 7

Flex: n =46 n =47 n=47 n =50

Loose dandruff 0 4 8 16
Adherent dandruff 4 12 15 20
Total dandruff 0 3 7 11

Tegrin: n =48 n =44 n =49 n =50

Loose dandruff 0 3 6 7
Adherent dandruff 5 10 15 18
Total dandruff 0 0 4 5

*The number of subjects evaluated at each visit varies because of missed visits
by some subjects

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Marvin Rapaport 155

2. Effects of Treatment (B) MEAN DANDRUFF SCORES

(A) DANDRUFF SCORES OF ZERO
A loose or adherent dandruff score of zero
signified that loose or adherent dandruff was
not observed on clinical examination. A total
score of zero represented the absence of both
loose and adherent dandruff. The number of
patients in each treatment group with scores of
zero at each visit during the study period is
shown in Table 2.
It is apparent from these data that adherent
dandruff was cleared more promptly, and in
more patients, than was loose dandruff. This
was true of all four treatment groups.
At the conclusion of the study period there
was complete clearance of dandruff (i.e., total
scores of zero) in a significantly larger
proportion of those on Selsun Blue (32%) than
among those on Head & Shoulders (15%), or
Tegrin (10%). In addition, the proportion of
patients with scores of zero was greater on
Selsun Blue (32%) than on Flex (22%), but the
difference was not statistically significant.
The mean scores for loose, adherent, and
total dandruff at the end of the lead-in period
and at each visit during the subsequent study
period for each treatment group, are shown in
Table 3.
The differences between the mean total
scores pre-study and at Week 4, which reflect
the improvement during treatment, were larger
on Selsun Blue (16·2) than with Head &
Shoulders (14·6), Flex (13·5) or Tegrin (13·1).
The influence of the pre-study scores, age,
sex, race, hair length and scalp condition on
the response to treatment was examined
statistically using the multiple regression
procedure. None of these factors except the
pre-study score had a significant effect on the
response in any of the treatment groups.
To test whether or not the improvement
from the initial score to the final score was
significantly different for any of the products,
an analysis of covariance was performed using
the initial scores as a covariate. The results of

Table 3
Mean dandruff scores at each evaluation

Week ofstudy

Pre-
study" 1 2 3 4

Se1sun: n =50 n =44 n =45 n =44 n=47

Loose dandruff 11·3 6·5 4·2 3·1 2·1
Adherent dandruff 8·2 4·0 2·4 1·9 1·1
Total dandruff 19·5 10·5 6·6 5·0 3·3··

Head & Shoulders: n=49 n =45 n =45 n =44 n=47

Loose dandruff 11·1 7·0 5·3 4·3 3·5
Adherent dandruff 8·9 4·5 3·5 3·1 1·9
Total dandruff 20·0 11·5 8·8 7·5" 5·4

Flex: n=50 n =46 n =47 n =47 n =50

Loose dandruff 10·5 5·7 4·6 3·5 2·7
Adherent dandruff 8·1 4·4 2·9 3·2 2·4
Total dandruff 18·6 10·1 7·5 6·6·· 5·1

Tegrin: n=50 n =48 n =44 n =49 n=50

Loose dandruff 11·2 6·3 5·5 4·3 3·8
Adherent dandruff 8·6 5·1 3·6 2·5 2·8
Total dandruff 19·8 11·4 9·1 6·8 6·7··

•At the end of the 2-week. lead-in period

··These total scores do not equal the sum of the loose and adherent scores because of
the 'rounding off of the mean loose and adherent dandruff

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156
this analysis and of pair-wise comparisons of
Selsun Blue with each of the other shampoos
indicated that the improvement on Selsun Blue
was significantly (p < 0·05) greater than on
Head & Shoulders, Flex, and Tegrin.
(C) RATE OF IMPROVEMENT
To determine if Selsun Blue produced a faster
rate of improvement than the other anti-
dandruff shampoos tested, a natural
logarithmic transformation of the total
dandruff scores was used to obtain a linear fit
over the baseline and 4 weekly scores.
Comparability of the estimates for the rate of
reduction on each treatment was tested using a
one-way analysis of covariance and when
found to be significant, pairwise differences
were tested using a one-sided t-test (p < 0·05).
The pair-wise analysis indicated that the
rate of reduction of total dandruff scores was
significantly (p < 0·05) faster for Selsun Blue
than for each of the other shampoos tested.
(D) ADVERSE EFFECTS
Two patients, one in the Head & Shoulders
group and one in the Flex group, reported
transient scalp irritation during the study
period. Both patients completed the course of
the study. There were no other complaints.
Discussion
The results of this study have shown that
Selsun Blue produced a significantly
(p < 0·05) greater reduction in total dandruff
scores (loose plus adherent dandruff) than
Head & Shoulders, Flex, or Tegrin. With
respect to the Selsun Blue - Head &
Shoulders comparison, these results are in
agreement with the findings of Kligman et al
(1974). They performed corneocyte counts as
a measure of anti-dandruff activity and found
selenium sulfide 2·5% to be significantly more
effective than Head & Shoulders. They
found that the response to Selsun was more
rapid, but that parity could occur after 6 to 8
weeks of twice weekly shampoos. In a
subsequent report (Kligman et al 1976), these
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The Journal ofInternational Medical Research
investigators noted that they had assessed the
effectiveness of zinc pyrithione and selenium
sulfide on numerous occasions and always
found a suppressant effect on dandruff, with
selenium sulfide being more potent.
On the other hand Orentreich et al (1969)
did not find statistically significant differences
in the anti-dandruff efficacy of shampoos
containing zinc pyrithione 2% and selenium
sulfide 2·5%, a preparation available on
prescription. The severity of the dandruff was
recorded before and after a variable period of
use, which was at least 6 weeks in duration.
Interim evaluations were not made and the
frequency of use of the shampoos was not
uniform.
Conclusions
On the basis of the results of our study we
conclude that selenium sulfide 1% is more
effective than the other anti-dandruff
preparations tested in the management of
dandruff.
Acknowledgements
We acknowledge the assistance of Stephen
R Schwartz, PhD, International Research
Services, Inc., in the conduct of this study.
REFERENCES
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Bourne S &; Jacobs A
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British Medical Journall, 1268
KUsman A M, Marples R R, Lantis L R &; McGInley K J
(1974) Appraisal of efficacy of anti-dandruff
formulations. Journal of the Society of Cosmetic
Chemistry 25, 73
KUsman A M, McGinley K J &; Leyden J J
(1976) The nature of dandruff. Journal of the Society of
Cosmetic Chemistry 27, 111
Orentreich N, Taylor E H, Berger R A &; Auerbach R
(1969) Comparative study of two anti-dandruff
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Roia F C &; Vanderwyk R W
(1969) Resident microbial ftora of the human skull and
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