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August 2003
The effects of minoxidil, 1% pyrithione zinc
and a combination of both on hair density: a randomized controlled trial.
Berger RS, Fu JL, Smiles KA, Turner CB, Schnell BM, Werchowski KM, Lammers KM.
Hill Top Research, Inc., East Brunswick, NJ, USA.
BACKGROUND: Recent studies of antidandruff shampoos or tonics containing
antifungal or antibacterial agents produced effects suggestive of a potential
hair growth benefit.
OBJECTIVES: The purpose of this 6-month, 200-patient,
randomized, investigator-blinded, parallel-group clinical study was to assess
the hair growth benefits of a 1% pyrithione zinc shampoo.
The efficacy of a 1% pyrithione zinc shampoo (used daily), was
compared with that of a 5% minoxidil topical solution (applied twice daily), a
placebo shampoo and a combination of the 1% pyrithione zinc shampoo and the 5%
minoxidil topical solution.
METHODS: Two hundred healthy men between the ages of 18 and 49
years (inclusive) exhibiting Hamilton-Norwood type III vertex or type IV
baldness were enrolled. Total hair counts, the primary efficacy measure, were
obtained using fibre-optic microscopy and a computer-assisted, manual hair count
method.
Secondary measures of efficacy included assessments of hair
diameter, as well as patient and investigator global assessments of improvement
in hair growth. These were based on photographs of the scalp using both midline
and vertex views.
RESULTS: Hair count results showed a significant (P < 0.05) net
increase in total visible hair counts for the 1% pyrithione zinc shampoo, the 5%
minoxidil topical solution, and the combination treatment groups relative to the
placebo shampoo after 9 weeks of treatment.
The relative increase in hair count for the 1% pyrithione zinc
shampoo was slightly less than half that for the minoxidil topical solution and
was essentially maintained throughout the 26-week treatment period.
No advantage was seen in using both the 5% minoxidil topical
solution and the 1% pyrithione zinc shampoo. A small increase in hair diameter
was observed for the minoxidil-containing treatment groups at week 17.
Assessments of global improvements by the patients and
investigator generally showed the benefit of 5% minoxidil. The benefit of the 1%
pyrithione zinc shampoo used alone tended (P < 0.1) to be apparent only to the
investigator.
CONCLUSIONS: Hair count results show a modest and sustained
improvement in hair growth with daily use of a 1% pyrithione zinc shampoo over a
26-week treatment period.
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