ELSEVIER

Medicated Shampoos
JERRY SHAPIRO, MD, FRCPC
STUART MADDIN, MD, FRCPC

W
hen do we need to use a medicated sham- Medicated Shampoos to Combat Dandruff
poo? Not infrequently the scalp may be the
site of an associated psoriasis, dandruff The following active antifungal agents are contained in
alone, or, in its severe form, seborrheic dermatitis. Oc- antidandruff shampoos: ketoconazole, zinc pyrithione,
casionally the scalp may be the site of a folliculitis. selenium, sulfur, and, most recently, piroctone olamine
Some patients complain of an itchy scalp that is not (Table 2).
accompanied by any classic signs and may be relieved The first reference to an infective cause of seborrheic
by more frequent shampooing. dermatitis was in 1873!’ The following year, a pit-
The information that follows concerning medicated yrosporon-like organism was described by Malassez,
shampoos will provide rational therapeutic options that who thought it was responsible for pityriasis capitis.*
we hope will prove useful (Table 1). We also provide Unna and Sabouraud confirmed these observations,
detailed information dealing with prescription-only and the etiologic agent was identified as Pityrosporum
medicated shampoos. ovaIe.2,3 In 1984, Shuster announced that P. or&e fulfilled
We dermatologists should be increasingly aware that the terms of Koch’s postulate as the etiologic agent re-
our patients look to us to supply information that will sponsible for dandruff and seborrheic dermatitis, since
permit them to make more informed choices at the con- they are linked to an excessive presence of P. ovule-
sumer level. Often we have brushed off patients or trivi- affected skin.*j5 Support for this hypothesis was further
alized their questions, perhaps because we were unable strengthened when it was determined that ketocona-
to answer the queries or our knowledge was derived zole was an effective antifungal agent for reducing the
from the same source as theirs and we knew nothing levels of Pityrosporum. It is now generally accepted
more. Our undergraduate and even graduate training that P. ovule is active in the pathogenesis of seborrheic
programs devoted very little time to the subject of dermatitis. During treatment, P. ozde levels are reduced
shampoos. In addition, standard dermatology text- or eliminated. With recurrence, the yeast can again be
books include a paucity of information on this subject. demonstrated.
Thus, much of the readily available patient and doc-
tor information concerning shampoos is supplied by Ketoconazole
industry. When one considers that the worldwide Of the more than a dozen imidazoles currently avail-
shampoo market is estimated to have exceeded $6 bil- able, the antifungal properties demonstrated by ketoco-
lion in 1993, it is easy to understand why industry dedi- nazole have made it a leading contender for the treat-
cates so much time and so many resources to shampoo ment of seborrheic dermatitis. The use of ketoconazole
products. Our major interest concerns medicated sham- 2% in a shampoo formulation has been demonstrated to
poos, which have an annual market value exceeding $1 be both safe and efficacious. Van Cutsem et al showed
billion. Medicated shampoos include specialized for- that ketoconazole was more effective than zinc pyrithi-
mulations that incorporate one or several agents that one or selenium sulfide in terms of reducing pityrospo-
alleviate the underlying scalp problem. Crude coal tar- rum counts.(j Faergemann demonstrated that ketocona-
containing shampoos for psoriasis are popular with the zole was more effective in vitro against Pityrosporum
consumer but are under attack because of the terato- than other azole derivatives, such as fluconazole, econa-
genie potential associated with their use. Because most zole, clotrimazole, and miconazole.7 Ketoconazole 2%
of the available information comes from industry, how- shampoo has been extensively studied in more than
ever, many of us may not even be sure whether medi- 2000 patients with dandruff or seborrheic dermatitis
cated shampoos confer any therapeutic benefit. against placebo, and the shampoo has been consistently
more effective than placebo.s-‘O Many other studies
have also demonstrated the superiority of ketoconazole
From the University of British Columbia Hair Clinic Research, Treut- shampoo.“-‘6
merit, and Transplant Centre, Division of Dermatology, Department of This shampoo has been compared to topical steroids.
Medicine, University of British Columbia, Vancouver, Canada.
Address correspondence to Dr. Jerry Shapiro, Clinical Associate Profes-
Ortonne et al reported that 1 month after treatment,
sor, Division of Dermatology, Department of Medicine, University of British reappearance of symptoms was more frequent in those
Columbia, 855 West 20th Avenue, Vancouver, BC VSZ lL7, Canada. treated with steroids, indicating that the ketoconazole

0 1996 by Elsevier Science Inc. 0738-081X/96/$32.00

655 Avenue of the Americas, New York, NY 10010 SSDI 0738-081X(95)001 19-O
124 SHAI’LRO AND MADDIN

Table 1. Medicated Shampoos Pyritlziotle Zirtc

Active ingredients used to combat dandruff Pyrithione zinc first became available in the [Link]
Ketoconazole reports su gested a significant reduction in cell turn-
Pyrithione zinc over rate.’ $-*I More recent studies using radioactive ici
Selenium
beling have failed to show any significant reduction in
Sulfur
Piroctone olamine mitosis after the use of zinc pyrithione.22,2’ Neverthtc-
Active ingredients used to combat bacterial infection less, the numbers of yeast organisms were markedI>
Triclosan reduced in these investigations, indicating that tht*
Chlorhexidine mechanism of action is more likely to be antimicrobial
Benzoyl peroxide
Salicylic acid
than cytostatic. The pyrithione moiety is the active part
Povidone-iodine of the molecule, and its clinical performance is awoci
Sulfur ated with the fact that it binds both to the hair shaft and
Active ingredients used to combat pediculosis to the external skin. The usefulness of pyrithione zinc
Lindane shampoo is enhanced with longer contact time (5 to li!
Malathion
minutes). The Dermatology Review Panel of the United
Permethrin
Pyrethrin States placed this agent in Category I for the treatment
Ac&re ingredients used to combat psoriasis of dandruff and seborrheic dermatitis (Table 3.
Coal tar
Salicylic acid
Sulfur Available since the 1950s, selenium in the form ttt
Selenium mixed sulfides, including selenium monosulfide and c1
suspension that incorporates solid selenium with sui-
fur, is used in the treatment of dandruff and seborrheii:
had longer-lasting antidandruff effects. Baran studied dermatitis. Although the exact mechanism of action ot
the effect of introducing ketoconazole foaming gel to selenium sulfide is still not clear, the antimicrobial
patients dependent on local steroid applications. This properties associated with this combination may play Cl
study showed that the frequency of steroid use was role. It is usually supplied as a 2.5% concentration.
reduced and that ketoconazole may play an important Gloor and Gehse believe that it is contraindicated for
role in protecting patients on long-term topical cortico- seborrheic patients because of its stimulating effect on
steroid use from potential side effects, such as skin at- sebaceous gland secretion.24 This shampoo must be
rophy.” rinsed thoroughly from the hair, to avoid discoloration.
As of January 1, 1995, ketoconazole shampoo is no Patients may complain of a residual odor and oily scalp
longer obtained by prescription in Canada, having gone after using selenium sulfide suspension shampoo. The
OTC. Dermatology Review Panel placed this agent in
Category I for the treatment of dandruff only.
Table 2. Shampoos for Seborrheic Dermatitis SlllfU~
DHS zinc shampoo Zinc pyrithione 2% Sulfur has been used extensively in dermatology for iti
Antidandruff Brylcreem Zinc pyrithione 1%
keratolytic effect and its supposed antimicrobial effect
Breck one Zinc pyrithione 1%
Danex Zinc pyrithione 1% and because it is safe even when used on small childrelt,
Head and Shoulders Zinc pyrithione 1% The keratolytic effect of sulfur is probably due to the
Zincon Zinc pyrithione 1% & surfactants reaction between the sulfur and the cysteine in kera-
Betadine Povidone 7.5% tinocytes. The supposed antimicrobial effect depends
Fostex medicated cleansing Sulfur 2%’ & salicylic acid 2%
on the conversion of sulfur to pentathionic acid by the
Ionil Salicylic acid 2%
X-seb Salicylic acid 4% normal skin flora or the keratinocytes. This has not been
Meted (detergent) Sulfur 3% & Salicylic acid 2% proved in humans. In vitro tests carried out by Bakker
pHis-Dan ppt sulfur 5% & Sodium salicylate et al showed that sulfur itself was unable to inhibit
0.5% growth of the microorganisms tested.‘” When used tk)
P&S Salicylic acid 2%
treat skin diseases, sulfur is usually employed in corn
Sebulex medicated shampoo Sulfur 2% & Salicylic acid 2R’,
surfactants bination therapy. The F&emI Register has proposed
Sebutone Sulfur 2% & salicylic acid 24, tar rules for its use,” and Lin et al have published “Sulfur
0.5% & surfactants Revisited.“”
Selenium sulfide 1% Selenium sulfide 1% and surfactants
Selsun Blue Selenium sulfide 1% & surfactants Piroctone Otnmine
Tegrin medicated shampoo Coal tar extract 5% In several studies, piroctone olamine has proved to hca
Zetar Whole colloidal coal tar 1% and highly effective against dandruff and the itching asso-,
chloroxylenol 0.5%
ciated with dandruff.28 Its mechanism of action is at-
Clinics in Dermatology l 1996;14:223-128 MEDICATED SHAMPOOS 125

Table 3. Status of Indications of Therapeutic Agents in Medicated Shampoos

Therapeutic Agent Treatment Status Indications for Use

Benzoyl peroxide (3%) Category II Folliculitis

Bifonazole Investigational Dandruff
Chlorhexidine acetate (O-0.5-1-3%) Category III Dandruff
Crude coal tar (l-S%) Recommended Psoriasis
Elfan 240 TS Investigational Psoriasis &
Seborrheic dermatitis
Fluconazole Investigational Dandruff
Fluoxol ST (l-5%) Investigational Sebosuppressive
Lindane Recommended Head lice
Ketoconazole (2%) Recommended Dandruff (seborrheic
dermatitis)
Malathion (1%) Recommended Head lice
Permethrin (1 Or,) Recommended Head lice
Piroctome olamine Investigational Dandruff
Pyrethrins Recommended Head lice
Povidone iodine (4%) Category Ill Folliculitis
Salicylic acid (2%) Category I Dandruff
Selenium sulfide (2.5%) Category I Dandruff/seborrheic
dermatitis/psoriasis
Softigen 767 Investigational Psoriasis/seborrheic dermatitis
Sulfur (2%) Recommended Dandruff
Triclosan (0.5-2%) Category Ill Folliculitis
Zinc pyrithione Category I Dandruff/seborrheic dermatitis

Category I, Il. G III we the designations nssigned by the Dermatology Review Panel, U.S.A

tributed to both its antimicrobial and its antioxidative been a companion of humans since prehistoric times.
action. The concentration used should be between 0.5% Head lice infestations remain a major public health con-
and 1.0%. Products containing this agent at these con- cern worldwide. Recent studies reveal that lice have
centrations are available in Europe. A comparative become firmly established in public schools. Through-
study of piroctone olamine and zinc pyrithione, both at out the United States and Canada, several million chil-
concentrations of 0.5%, showed that piroctone olamine dren are affected annually.
was more effective in the treatment of dandruff.
Lindane
Medicated Shampoos to Combat Lindane became available in the 1940sfor the treatment
Bacterial Infection of pediculosis capitis and scabies. Concern has recently
developed over the possible application of higher than
The following active agents are contained in so-called normal concentrations to the skin. Children are consid-
antibacterial shampoos: triclosan, chlorhexidine, ben-
ered to be particularly at risk, and percutaneous absorp-
zoyl peroxide, salicylic acid, poviodine-iodine, and sul-
tion may cause central nervous system toxicity.31 Now
fur.29
that other effective, safer treatment agents are available,
Although the surface of the scalp is teeming with
the use of lindane shampoo has decreased.
bacteria, they are usually members of the normal resi-
dent aerobic and anaerobic scalp flora. Bacteria present Malathion
on the hair shafts are easily removed by shampooing
Although classified as an organophosphorous pesti-
but are restored to their original level within 24 hours.
cide, malathion has an excellent safety profile.32 In
Bacteria on hairs are usually inconsequential, but under
some nations, such as the United Kingdom, malathion
certain circumstances bacteria such as Staphylococcusau-
has displaced lindane for the treatment of pediculosis
retls may involve the follicle, resulting in a staphylococ-
and [Link], patients complain of the un-
cal folliculitis. Antibacterial-containing shampoos are of
pleasant odor associated with malathion shampoo. Mal-
limited benefit in the management of scalp folliculitis.
athion is not currently available in the United States.

Medicated Shampoos to Combat Pediculosis Permethvin

The following active agents are contained in shampoos Permethrin is one of the most suitable of the pyre-
to combat pediculosis: lindane, malathion, permethrin, throids because of its stability, low mammalian toxicity,
and pyrethrin. and high insecticidal activity. Permethrin 1% cream
Pediculus humanus var. capitis, the head louse, has rinse has been approved for use on prescription by the
126 SHAPIRO AND MADDIN

FDA since April 1986. 30 It is available as a mixture of Table 4. Shmnyoos for Psoriasis
25% cis- to 75% trans-isomers and formulated as 1% Denorex extra-strength Coal tar solution 12.5% &
permethrin in a standard commercial cream hair rinse menthol 1.5%
to which is added 20% isopropanol. The cis-isomer has DHS tar shampoo Coal tar 0.5%’
a higher potential for mammalian toxicity than the DHS tar gel Coal tar 0.5%
Duplex T Coal tar solution 10% & sodmm
trans-isomer, which is more rapidly metabolized. lauryl sulfate 15%
The 25:75 cis:trans ratio was preferred for human use locon Coal tar solution
because of the lower levels of &-isomer. Bowerman et Neutragena T gel Coal tar 2%’
al. compared lindane shampoo, permethrin 1% cream Neutragena T/solution Coal tar 2%, salacvlic acid 2’Ji
rinse, and placebo in 93 patients.33 At 14 days after Pentrax Coal tar 8.75% ’
Polytar Polytar 1%
treatment, 97% of patients treated with permethrin
Psorex Coal tar 1%
were free of lice compared to 6% of placebo-treated Targum shampoo Salicylic acid 5%
patients and 43% of the lindane-treated group. Perme- Tegrin Coal tar 50/c,allantoin 1.7%
thrin was 70% ovicidal compared to 45% for lindane. Tersa tar far distillate 3%
No adverse side effects were detected. Furthermore, Vanseb-T tar dandruff shampoo Sulfur 2%!, coal tar 5%, salicylic
acid, 1%
permethrin bonds to hair longer than lindane. Bower- Zetiu Whole colloidal tar 15;.,
man et al treated 1040 patients with either lindane or chloroxvlenof 0.5%
i -I__-- _...
permethrin: 98% of patients treated with permethrin
compared to 76% patients treated with lindane were
louse-free 2 weeks after treatment.33 Mild dermal reac- riod if the patients were using tar shampoo. There are,
tions such as pruritus and erythema occurred in 1.2% of however, no studies that compare the effectiveness of
permethrin-treated patients and 2.6% of lindane-treated one tar-containing shampoo agent to another.
patients. A recent report by Van Schooten et al questions
whether coal tar-containing shampoos should be sold
Pyrethrins without prescription and suggests that a limit be set for
Pyrethrum is an extract from chrysanthemums that pro- the level of polycyclic aromatic hydrocarbons @‘AH)
vides a naturally occurring insecticide effective for the contained in coal tar-containing shampoos.“7 It has
treatment of scabies and pediculosis. Pyrethrin’s action been demonstrated that human exposure to PAH is as-
is enhanced when the agent is combined with piperonyl sociated with an increased risk of cancer.
butoxide. With the introduction of the synthetic pyre- Wood tars, oil of Cade, and pine tars were removed
throid permethrin, the use of the pyrethrin shampoo from shampoos on the recommendation of the FDA in
formulations has diminished.34 1990 because their efficacy had not been established.

Medicated Shampoos to Combat Psoriasis Salicylic Acid, Sulfur, and Selenium

Clinical experience suggests that shampoos that include
The following active agents are contained in shampoos one or a combination of these agents have some effec-
to combat psoriasis: crude coal tar, salicylic acid, sulfur, tiveness in the management of mild to moderate scalp
and selenium (Table 4). psoriasis. A review of the literature fails to prove the
effectiveness of these drugs when they are incorporat_ed
Coal Tar
in a shampoo.
Coal tar is a byproduct that follows the destructive dis-
tillation of bituminous coal and is a complex mixture of Medicated S&npoos: Future Trends
aromatic hydrocarbons and phenuls. Tar-containing
shampoos are frequently used for the treatment of pso- Although no one can predict what new agents will be-
riasis and seborrheic dermatitis. The exact mechanism come available for use in medicated shampoos, there
of coal tar’s action is unknown, but it exhibits a cyto- are a number of possibilities [Link] we think worth men-
static effect after long use (40 days) at a 5% concentra- tioning (Table 5).
tion. Lowe et al have shown that commercial coal tar
supresses epidermal cell DNA synthesis in the hairless Table 5. Medicated Shampoos-Future Trends
mouse mode1.35 The assay they used revealed a wide
Antifungal
variation in the efficacy of tar products in terms of sup- Bifonazole
pressing DNA synthesis. Coal tar shampoo is the one Fluconazole
most useful in the treatment of scalp psoriasis. Langner Terbenafine
et al demonstrated the effectiveness of tar-containing Surfactants
shampoo in the maintenance therapy of scalp psoria- Crude coal tar distillates
Lithium succinate
sis.% Psoriasis remained in remission for a longer pe-
Clinics in Dermatology l 1996;14:123-128 MEDICATED SHAMPOOS 127

Antifungal Agents shampoos include drugs that exhibit specific mecha-

Some of the newer antifungals-such as bifonazole and nisms of action and are able to control the underlying
fluconazole-may be found to be more effective than scalp complaint.
our existing formulations in the next generation of an- The basis of the information provided, will we hope,
tidandruff shampoos. Terbenafine in a shampoo may permit the dermatologist to make more rational deci-
also prove to be useful. Ketoconazole shampoo may be sions when asked by patients to suggest an appropriate
of value as conjunctive therapy for tinea capitis. shampoo.
BIFONAZOLE Bifonazole 1% shampoo has been studied
by Segal et al in 44 patients in a double-blind, vehicle- References
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seborrhoeic dermatitis: A randomized, double-blind, pla-
The sebosuppressive effect of crude coal tar distillate
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(Flux01 ST, 1.5%) has been established.24 Because exces-
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comed. This new distillate, however, shares with other management of dandruff. J Dermatol Treat 1990;1:177-9.
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nazole 2% shampoo versus selenium sulfide 2.5% sham-
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