Topical eflornithine hydrochloride improves the

effectiveness of standard laser hair removal for

treating pseudofolliculitis barbae: A randomized,
double-blinded, placebo-controlled trial
Yang Xia, MD,a Sunghun Cho, MD,b Robin S. Howard, MA,c and Kurt L. Maggio, MDd
San Antonio, Texas; Grafenwoehr, Germany; and Washington, District of Columbia

Background: Pseudofolliculitis barbae (PFB) significantly impacts the military population, especially
deployed personnel.

Objective: This study was designed to determine whether the addition of topical eflornithine to hair laser
treatment would improve efficacy in treating PFB.

Methods: This was a randomized, double-blinded, placebo-controlled, paired (right and left neck)
comparison study examining a combination of eflornithine and hair laser versus placebo and hair laser for
the treatment of PFB. In all, 27 male patients with clinical PFB were treated with a long-pulsed
neodymium:yttrium-aluminum-garnet laser with an energy fluence of 25 to 30 J/cm2, a pulse duration of 20
to 30 milliseconds, and a 10-mm spot size to the entire bearded neck region. The laser treatment was
performed every 4 weeks for a total of 16 weeks. Between laser treatments, patients applied eflornithine
and placebo creams twice daily to opposite sides of the bearded neck region. The number of hairs and
inflammatory papules were counted bilaterally at each visit.

Results: The eflornithine side had a statistically significant decrease in the number of hairs and
inflammatory papules compared with the placebo side. At 16 weeks, the eflornithine side had a median
hair reduction of 99.5% from baseline (range 48.5%-100.0%), whereas the placebo side had an 85.0%
median hair reduction from baseline (range 50.5%-94.5%), P less than .001.

Limitations: Patients were not followed up beyond 16 weeks.

Conclusion: The addition of topical eflornithine to hair laser treatment decreased hairs and inflammatory
papules faster when compared with hair laser therapy alone in the treatment of PFB. ( J Am Acad Dermatol
2012;67:694-9.)

Key words: eflornithine hydrochloride; hair laser; pseudofolliculitis barbae.

L aser hair removal has become the gold stan-

dard in treating pseudofolliculitis barbae
(PFB).1-5 Most patients have a significant de-
crease in hair density after 4 to 5 laser treatments
Abbreviations used:
CI:
ICC:
PFB:
confidence interval
intraclass correlation coefficient
pseudofolliculitis barbae
performed 4 to 6 weeks apart.

From the Dermatology Service, San Antonio Uniformed Services
Health Education Consortiuma; Dermatology Clinic, Bavaria
Medical Activity, Grafenwoehrb; and Department of Clinical
Investigationsc and Dermatology Service,d Walter Reed Army
Medical Center, Washington.
Funding sources: None.
Conflicts of interest: None declared.
The opinions herein are the private views of the authors and do
not reflect the official policy of the Department of the Army,
Department of Defense, or US Government.
Accepted for publication October 25, 2011.
Reprints not available from the authors.
Correspondence to: Yang Xia, MD, Dermatology Service, San
Antonio Uniformed Services Health Education Consortium,
2200 Bergquist Dr, Ste 1, San Antonio, TX 78236. E-mail:
yang.xia@us.army.mil.
Published online January 9, 2012.
0190-9622/$36.00
Ó 2011 by the American Academy of Dermatology, Inc.
doi:10.1016/j.jaad.2011.10.029

694
J AM ACAD DERMATOL Xia et al 695
VOLUME 67, NUMBER 4

Recently, there have been reports of using eflor-
nithine hydrochloride 13.9% cream as an adjunct
therapy in treating unwanted facial hairs in women
with minimal side effects.6 Eflornithine hydrochlo-
ride acts by inhibiting ornithine decarboxylase, an
enzyme involved in hair cell division.7 As a result, the
medication can reduce the growth of the active hair
follicles. Based on these stud-
ies, there have been several
anecdotal reports on the ben- CAPSULE SUMMARY
efits of using eflornithine in
Eflornithine hydrochloride 13.9% cream
treating patients with PFB.2,3
d
The laser treatment was performed with a long-
pulsed neodymium:yttrium-aluminum-garnet laser
(Coolglide, Cutera Inc, Brisbane, CA). The laser
incorporated a built-in copper cooling system at
the laser tip. Laser settings used in this study were:
energy fluence of 25 to 30 J/cm2, pulse duration of 20
to 30 milliseconds, and 10-mm spot size. A clear,
colorless gel was applied to
the treatment area before the
laser therapy. The same laser
settings were used on both

sides of the neck at each

has been reported as an effective
However, to our knowledge, subsequent session. The de-
adjunct therapy in treating unwanted
there are no published data sired immediate end points
facial hairs in women.
in the literature concerning for the laser treatment were
the efficacy of combing laser d We found that patients with perifollicular erythema and
therapy with eflornithine for pseudofolliculitis barbae required two edema.
the treatment of PFB. fewer hair laser treatments with the After the first laser treat-
The main purpose of this addition of eflornithine hydrochloride as ment, patients received two
study was to determine if the an adjunct therapy. identical 30-g jars from the
addition of eflornithine hy- d Eflornithine hydrochloride should be Walter Reed Army Medical
drochloride 13.9% cream be- used in conjunction with hair laser to Center research pharmacist.
tween laser hair removal maximize overall treatment benefit in To distinguish the two jars of
treatments will decrease the patients with pseudofolliculitis barbae. medication, one jar was la-
number of detectable hairs beled ‘‘right’’ and the other
and inflammatory papules jar was labeled ‘‘left.’’ A thick
faster when compared with using laser therapy layer of contents was applied by the patient to the
with placebo cream in patients with PFB. corresponding areas of his bearded neck region
twice a day. One jar contained eflornithine hydro-
METHODS chloride 13.9% cream and the other jar contained a
This randomized, double-blinded, placebo- placebo cream. The patients were also instructed
controlled, paired comparison study was approved to wash their hands after each application.
by the Walter Reed Army Medical Center Human Use Randomization of the two jars was performed by
Committee/Institutional Review Board. In all, 33 the research pharmacist, with men assigned in a 1:1
male patients 18 years or older (Fitzpatrick skin ratio using a computer program based on random
type II-VI) with a clinical diagnosis of PFB and number generation. Both patients and physicians
without prior laser hair treatments were interviewed. were blinded as to which jar contained eflornithine
Six patients declined to participate after discussion of or placebo. The blinding was broken only after the
the study. The remaining 27 patients were enrolled in last patient received his laser hair treatment at week
the study (Fig 1). All patients provided written 16. Compliance was measured by the research
informed consent. pharmacist at each follow-up visit by weighing the
The bearded neck region was used for this study two jars from the previous visit. Patients were issued
because it is the most common site for the develop- two new jars of eflornithine and placebo at each
ment of PFB from shaving. Also, this area can be well follow-up visit.
delineated for bilateral comparison purposes. All Hair counts and inflammatory papules were
patients had to have predominantly dark-bearded assessed at baseline and at 4-week intervals in
hairs. The patients were instructed to shave regularly concurrence with the laser treatments. The number
throughout the duration of the study especially of hairs and inflammatory papules were counted
before each hair laser treatment. They were also within two 2-cm circles as a representation of the
asked to discontinue all other treatment modalities of total number of ingrown hairs and inflammatory
hair removal (eg, plucking, waxing, chemical depil- papules on the bearded neck region. The circles
atories) approximately 4 weeks before the first laser were measured at the junction of the chin and front
treatment. of neck (Fig 2). The measurement was done pre-
Each patient was scheduled for 4 laser treatments cisely so that the circles could be drawn in the same
at 4-week intervals to the entire bearded neck region. locations at each subsequent visit. To measure
696 Xia et al
Fig 1. Study outline.
Fig 2. Two 2- 3 2-cm circles measured at junction of chin
and front of neck. Number of hairs and inflammatory
papules were counted within two 2- 3 2-cm circles as
representation of total number of ingrown hairs and
inflammatory papules on bearded neck region.
interrater reliability of the counts of hairs and pap-
ules, assessments were completed independently by
the principal investigator (X. Y.) and a coinvestigator
J AM ACAD DERMATOL
OCTOBER 2012
(K. L. M.). Both were board-certified dermatologists.
The final assessment for each patient was performed
at his final visit at week 16.
Sample size justification was based on a previous
study in which the mean percentage reduction in
papules/pustules using laser treatment alone was
80% with a SD of 11.6%.1 Controlling the probability
of a type I error at alpha = 0.05, a sample of 17 men
would have 90% power to detect a difference of 10%
between treatments in the percentage reduction in
papules/pustules. Additional patients were obtained
to allow for loss to follow-up.
Interrater reliability is described by the intraclass
correlation coefficient (ICC) (2,1) using a two-way
random effects model based on absolute agreement
together with 95% confidence intervals (CI). The
average count of hairs and papules for both raters
was used in the analysis of efficacy. These counts
were not normally distributed and are presented
using medians with either the interquartile range or
with ranges (minimumemaximum) and compared
using the Wilcoxon signed rank test. Analysis was on
an intention-to-treat basis: all data from both sides of
J AM ACAD DERMATOL
VOLUME 67, NUMBER 4
Fig 3. Median and interquartile range for number of hairs
at each visit for placebo- and eflornithine-treated sides. *P
\ .0005 at each visit by Wilcoxon signed rank test.
the neck for all men returning for follow-up were
used in the analysis. Compliance is described using
an ICC (2,1) and weights were compared between
the eflornithine and placebo jars using the Wilcoxon
signed rank test. The association of cream use and
hair and papule counts was examined using
Spearman correlation coefficient. Data were ana-
lyzed using software (SPSS for Windows, v 17, SPSS
Inc, Chicago, IL).
RESULTS
In all, 27 patients ranging in age from 20 to 43
years consented to participate in the study and
underwent treatment. Of these, 24 patients were
African American and 3 patients were Caucasian.
There were no reported side effects in using the
medications. Both the patients and the investigators
noted no difference of the eflornithine cream in
regard to color, smell, or consistency as compared
with placebo.
Hair and papule counts were completed for all
men at the 4-week follow-up. In all, 26 patients
(96%) were available at the 8-week appointment and
24 patients (89%) returned for the 12- and 16-week
visits. Compliance data were available for 26 men
(96%) who returned both jars at the 4-week visit; this
number decreased to 21 (78%), 19 (70%), and 13
(48%) at subsequent visits. Use of creams varied
widely between patients, from 0.10 to 29.6 g remain-
ing in jars at each visit, but patients used a similar
amount of each cream on the right and left sides
(ICC = 0.94). Patients used slightly more eflornithine
cream, with a median difference of 1.8 g (range 7.5
to 6.4 g) between jars (P = .001). There was no
significant association between the difference in
amount of cream used and treatment differences
for either hair or papule count.
Overall interrater reliability was excellent for both
counts of hair with an ICC = 0.96 (95% CI 0.94-0.97)
and for papules with an ICC = 0.93 (95% CI
0.91-0.95).
Xia et al 697
Fig 4. Median and interquartile range for number of
papules at each visit for placebo- and eflornithine-
treated sides. *P \ .008 at each visit by Wilcoxon signed
rank test.
There was no significant difference in the baseline
number of hairs, with a median count of 42 hairs
(range 32-84) on the eflornithine-treated side com-
pared with 46 hairs (range 26-90) on the placebo-
treated side (P = .25). There was a significant
decrease in the median number of hairs on the
eflornithine-treated side when compared with the
placebo-treated side at each follow-up (P \ .0005)
for all visits (Fig 3). The eflornithine-treated side had
statistically significantly fewer hairs at 8 weeks com-
pared with the placebo-treated side at 16 weeks (P =
.038). At 16 weeks, the eflornithine-treated side had a
median 99.5% reduction from baseline (range 48.5%-
100.0%), whereas the placebo-treated side had 85.0%
median hair reduction from baseline (range 50.5%-
94.5%). The eflornithine-treated side provided a
median additional reduction in hairs from baseline
of 10.6% (interquartile range 8.4%-18.9%) and was
more effective in 22 of 24 patients (92%; 95% CI
73%-99%).
Baseline papule counts were similar between
eflornithine- (median = 21, range 7-51) and placebo-
(median = 21, range 6-43) treated sides (P = .33).
There was a significant decrease in the number of
inflammatory papules on the eflornithine-treated
side when compared with the placebo-treated side
at each follow-up (P\.008) for all time points (Fig 4).
DISCUSSION
We noted a more substantial decrease in the
number of hairs and inflammatory papules on the
eflornithine side at the first follow-up visit. This trend
became more clinically evident at each subsequent
follow-up visits (Fig 5). We also found that the
number of hairs on the eflornithine-treated side
was significantly less at week 8 than the number of
hairs on the placebo-treated side at week 16.
In looking at the trends reflected by Figs 3 and 4,
we hypothesize that the initial decrease in the
698 Xia et al
Fig 5. Bearded neck region of 33-year-old man at baseline (A) and 16 weeks (B). In this patient,
eflornithine (E ) was applied to right side and placebo (P) was applied to left side. His hair
density was considerably less on E side (red circles) versus P side ( green circles) at week 16.
number of hairs at week 4 for both sides was
predominantly the effects of the hair laser. From
weeks 8 to 16, the differences in the number of hairs
between the two sides are likely because of the
effects of eflornithine. This correlates well with
previous reports of clinically significant hair reduc-
tion often seen starting at week 8 of eflornithine
use.6,8 The addition of eflornithine likely halts the
regrowth of the remaining viable hair follicles after
initial laser destruction of the follicles through selec-
tive photothermolysis.9 The slight increase in the
number of hairs on the placebo-treated side at week
12 may be attributed to the paradoxical hair growth
from repeated hair laser treatments. The number of
inflammatory papules decreased steadily for both
eflornithine and placebo from weeks 8 to 16. This is
likely the result of fewer remaining hairs that re-enter
the skin to cause the inflammatory papules.
Our patients with PFB achieved a greater clear-
ance of their ingrown hairs after two laser treat-
ments in combination with eflornithine as
compared with 4 laser treatments alone. The results
from our study may have significant positive impli-
cations for patients with PFB, to include our active
duty military soldiers and those patients who desire
reduced hair growth. Although the standard treat-
ment for PFB in the military is 4 to 6 laser treatments
spaced 4 to 6 weeks apart, our patients may not
have the time to complete a full treatment cycle
because of deployments, training, or relocations.
Having to treat patients for a shorter duration with
the combination therapy may also be equally effec-
tive in reducing the number of potential complica-
tions from PFB to include scarring, keloids, and
infections.
J AM ACAD DERMATOL
OCTOBER 2012
The addition of eflornithine could result in sub-
stantial cost savings to both patients and the health
care system. Our data indicated the patient would
require two fewer laser hair therapies with the
combination treatment. The average amount of
eflornithine cream used on the entire bearded neck
region was 30 g every 4 weeks. A 30-g tube of
eflornithine costs $90 to $130. The estimated cost for
eflornithine use for the first 8 weeks would be $180
to $260. Individual hair laser treatment can range
from $200 to $300 per session. Therefore, the cost
savings of using eflornithine for the first 8 weeks and
foregoing the final two laser treatments would be
$220 to $340 per patient.
The limitation of the study was that patients
were not followed up beyond 16 weeks and we did
not evaluate whether eflornithine could be used as
a stand-alone adjunctive therapy after the laser
treatment was complete. We believe that if eflorni-
thine was stopped at the end of the last laser
treatment, a patient’s PFB could worsen as viable
hair follicles become active again. Therefore, pa-
tients with PFB may need to continue to use
eflornithine therapy after the conclusion of hair
laser treatments. It would be beneficial to know if
eflornithine therapy alone will sustain the clinical
response after the initial laser hair treatments. A
longer study will be undertaken in the future to
answer this question.
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