A Study of Possible
Role of Contact Period on the Efficacy of Antidandruff Shampoo
Juned Khan1,
Ajazuddin1, SJ Daharwal2 and Deependra
Singh2*
1Rungta
2Institute
of Pharmacy,
ABSTRACT
Many people
suffer from dandruff problem. The dandruff occurs generally on the hair covered
skin, specially the scalp skin. It is known to be controlled by antifungal
agents. The present study was carried out to asses the effect of three minutes
contact period on the efficacy of antidandruff shampoos. 1% Ketoconazole,
1% Piroctone olamine and 1%
Zinc pyrithione were individually formulated in a
shampoo base and were used for the study. Three groups of ten patients each
with severe dandruff were taken such that each group was treated with only one
of the antidandruff agent. Scoring of the dandruff was done on a 0 to 10 scale
for each of the three regions of scalp at first and fourteenth day
respectively. All the three antidandruff shampoo treated groups improved
significantly with a contact period of three minutes rather than no contact
period.
INTRODUCTION
Dandruff is a global
phenomenon and many people find that dandruff can cause social or self-esteem
problems. It is more common at age between 20-30 years. It can be controlled by
fungistatic agents active against Malassezia as dandruff is associated
with the presence of yeast or fungi of this genus1, 2. The yeasts of
the genus Malassezia have been associated with a number of diseases affecting
the human skin, such as pityriasis versicolor, Malassezia (Pityrosporum)
folliculitis, seborrheic
dermatitis and dandruff, atopic dermatitis, psoriasis, and--less commonly--with
other dermatologic disorders such as confluent and reticulated papillomatosis, onychomycosis,
and transient acantholytic dermatosis.
Although Malassezia yeasts are a part of the normal microflora,
under certain conditions they can cause superficial skin infection3, 4.
While
this fungus is found naturally on the skin surface of both healthy people and
those with dandruff, it was discovered that a scalp specific fungus, Malassezia
globosa, is the responsible agent. This fungus metabolizes triglycerides
present in sebum by the expression of lipase, resulting in a lipid byproduct oleic
acid (OA). Penetration by OA of the top layer of the epidermis, the stratum corneum, results in an inflammatory response in susceptible
persons which disturbs homeostasis and results in erratic cleavage of stratum corneum cells5.
Dandruff (also called scurf and historically termed Pityriasis capitis)
is due to the excessive shedding of dead skin cells from the scalp. As it is
normal for skin cells to die and flake off, a small amount of flaking is normal
and in fact quite common. Some people, however, either chronically or as a
result of certain triggers, experience an unusually large amount of flaking,
which can also be accompanied by redness and irritation. Most cases of dandruff
can be easily treated with specialized shampoos. Dandruff is uncommon in
children ages 2-10, but the incidence begins to rise precipitously as patients
approach puberty. From that time, dandruff incidence rises even more rapidly
until patients reach their early twenties, when it begins to fall. The number
of affected people drops slowly until it becomes uncommon in middle-aged
patients and the elderly6.
Dandruff is not an organism like lice; it is just dead skin that
accumulates in the scalp. Dandruff is unlikely to be the cause of hair loss.
Table-1
|
Dandruff affected area |
Dandruff score |
||||||||
|
Ketoconazole (1%) |
Piroctone olamine (1%) |
Zinc pyrithium (1%) |
|||||||
|
Day-1 |
Day-8 |
Day-14 |
Day-1 |
Day-8 |
Day-14 |
Day-1 |
Day-8 |
Day-14 |
|
|
Frontal |
2.83± 0.98 |
2.29± 1.02 |
1.99± 1.01 |
2.91± 0.77 |
2.69± 1.05 |
2.00± 0.93* |
2.78± 0.98 |
2.09± 0.95 |
1.67± 1.01* |
|
Temporal |
2.56± 0.78 |
1.97± 1.10 |
1.89± 0.96 |
2.72± 0.95 |
2.08± 1.0 |
1.59± 0.82 |
2.77± 0.78 |
2.13± 1.12 |
1.77± 0.86* |
|
Occipital |
2.78± 1.12 |
2.56± 1.32 |
1.93± 1.14 |
2.32± 1.01 |
2.14± 1.13 |
1.96± 1.06 |
2.87± 1.12 |
2.45± 1.02 |
1.43± 0.74* |
Dandruff scores at
three different sites for no contact period
The result has been
analyzed by students ‘t’ test. P<0.05 has been considered as
significant.*p<0.5, **p<0.1
Table-2
Dandruff scores at
three different sites with a contact period of three minutes
|
Dandruff affected area |
Dandruff score |
||||||||
|
Ketoconazole (1%) |
Piroctone olamine (1%) |
Zinc pyrithium (1%) |
|||||||
|
Day-1 |
Day-8 |
Day-14 |
Day-1 |
Day-8 |
Day- 14 |
Day-1 |
Day-8 |
Day-14 |
|
|
Frontal |
2.99± 1.10 |
2.13± 0.98 |
1.05± 0.95* |
2.76± 0.92 |
1.23± 0.81 |
1.01± 0.35* |
2.61± 0.87 |
1.67± 0.57* |
1.34± 0.79* |
|
Temporal |
2.74± 0.85 |
1.82± 0.89** |
1.15± 0.71** |
2.15± 0.95 |
1.78± 0.65* |
1.00± 0.76** |
2.81± 1.07 |
2.10± 0.86 |
1.23± 0.82* |
|
Occipital |
2.83± 0.97 |
2.06± 1.12 |
1.25± 0.80* |
2.49± 0.89 |
1.64± 0.93* |
0.93± 0.42* |
2.87± 0.99 |
1.34± 1.00 |
0.91± 0.56** |
The result has been
analyzed by students ‘t’ test. P<0.05 has been considered as significant. *p<0.5,
**p<0.1
Table-3
Profile of untoward
effects due to application of antidandruff shampoo
|
Events
|
No
contact period |
3
min contact period |
||
|
Number
of patients |
Percentage
(%) |
Number
of patients |
Percentage
(%) |
|
|
Irritation
|
01 |
6.6 |
-- |
-- |
|
Itching
increased |
-- |
-- |
-- |
-- |
|
Burning
|
-- |
-- |
01 |
6.6 |
|
Loss
of hair |
-- |
-- |
01 |
6.6 |
|
Dryness
of hair |
02 |
13.3 |
02 |
13.3 |
|
Total
|
03 |
19.9 |
06 |
26.5 |
Dandruff is
a global phenomenon and many people find that dandruff can cause social or
self-esteem problems. Treatment may be important purely for psychological
reasons.
The common
preparations for the treatment of dandruff include Ketoconazole,
Itraconazole, selenium, Zinc pyrithione,
sulfur and Piroctone olamine..These
agents also remove loosely attached scales from the scalp. Various studies have
reported management of dandruff7, 8. In this study 1% Ketoconazole, 1% Piroctone olamine and 1% Zinc pyrithione
have been separately formulated with shampoo base and used. This study has been
performed to identify the potential role of contact period on efficacy of
anti-dandruff shampoo.
MATERIAL
AND METHODS
Material
All the chemicals were
procured from Central Drug House (P) Ltd, Valsad,
Preparation
of shampoo
1% Ketoconazole,
1% Zinc pyrithione and 1% Piroctone
olamine were individually dispensed in a shampoo base9.
Method
of study
Study was conducted on
college students. General examination of the subjects was done for their
inclusion in study. Students with history of hypersensitivity to shampoos, and
those with dermatitis or other skin diseases were not included in the study. A
preliminary examination of dandruff was done with the subjects. They were
divided broadly into three different groups each with ten subjects. Each group
was divided into two subgroups one of which were asked to rinse the shampoo
immediately after application (0min contact period) and the other subgroup was
asked to rinse after three minutes of contact period (3 mins
contact period). Grading of dandruff was done in three regions of scalp
(frontal, temporal and occipital) and dandruff scores were given as follows:
0-2=none/slight
3-4=mild
5-6=moderate
7-8=marked
9-10=severe
Patients were asked to
use the shampoo once in two days for a period of two weeks. They were asked to
wash the scalp with warm water and apply good quantity of shampoo to produce
sufficient lather. A massage of 3 minutes was advised for one subgroup. Profile
of untoward effects such as itching and erythema was
also prepared and graded as:
0=absent
1=mild
2=moderate
3=severe.
Statistical analysis:
Students ‘t’ test was used and results were expressed as Mean± SEM. P<0.5
was considered significant.
RESULTS
AND DISCUSSION
The patients selected
were of age between 18-27 years. Both males and females were selected for the
study. The duration of disease ranged from one month to three years.
Table-1 indicates the
change in dandruff scores at three different regions of the scalp on first,
eighth and fourteenth day of the study for patients with zero contact period of
shampoo with the scalp. Fall in dandruff level was significant in frontal
region for piroctone olamine
treated group on fourteenth day of the study. For zinc pyrithione
treated group the result was significant for all the three regions of scalp on
fourteenth day (p<0.05). Ketoconazole did not
exhibit any significant decrease in dandruff level.
Table-2 shows the
change in dandruff scores at three sites with a contact period of three
minutes. All the three treated groups showed significant decrease in dandruff
score on eighth and fourteenth days of the study. The scores were significantly
lower as compared with the scores of different treated with zero contact
periods. Table-3 shows the profile of untoward events occurred in 19.9% of
patients in the group with zero contact period, whereas in three minutes
contact period group it was 26.5%. This difference between the two groups is
not significant.
The effect of contact
period of antidandruff shampoo on its efficacy has been studied in this study. Ketoconazole and Piroctone olamine belongs to the class of antifungal drugs11.
They are believed to be active against Malassezia furfur
which is closely associated with seborrhoeic
dermatitis and dandruff. Zinc pyrithione possesses
anti-mycotic property and is established for
treatment of dandruff and other scalp conditions. Many marketed shampoos of
zinc pyrithione 1% are available12, 13.
In this study both the
zinc pyrithium and piroctone
olamine showed better anti-dandruff properties than Ketoconazole. On a three minute contact period all the
shampoos showed better results than without any contact period. All the three
showed significant decrease (p<0.05 and p<0.1) in dandruff scores with a
contact period of three minutes. With zero contact period of the anti dandruff
shampoo the decrease in dandruff scores was less significant (p<0.05) that
too on fourteenth day of the study. The untoward effect profile did not show
any significant difference between the zero contact period group and three
minute contact period group. Both the groups did not show any major untoward or
adverse effects to the subjects. Thus it justifies that application of
anti-dandruff shampoos with a contact period of three minutes is safe and more
effective than the use of shampoo without any contact period.
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Received on
06.06.2009
Accepted on
15.06.2009
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Research
Journal . of Pharmaceutical Dosage Forms and Technology. 1(1): July.-Aug. 2009, 38-40