Journal of Cosmetics, Dermatological Sciences and Applications, 2012, 2, 179-183
http://dx.doi.org/10.4236/jcdsa.2012.23034 Published Online September 2012 (http://www.SciRP.org/journal/jcdsa)
179
Treatment of Acne Vulgaris with 5-Alpha Avocuta Cream
2% in Comparison with Tretinion Cream 0.025% (Single
Blind Comparative Study)*
Khalifa E. Sharquie1#, Hayder R. Al-Hamamy2, Adil A. Noaimi2, Ali F. Tahir3
1Scientific Council of Dermatology and Venereology-Iraqi Board for Medical Specializations, Baghdad, Iraq; 2Department of Der-
matology and Venereology, College of Medicine, University of Baghdad, Baghdad, Iraq; 3Department of Dermatology and Vener-
eology, Baghdad Teaching Hospital, Baghdad, Iraq.
Email: #ksharquie@yahoo.co.uk
Received March 15th, 2012; revised April 20th, 2012; accepted May 2nd, 2012
ABSTRACT
Background: Acne vulgaris is a common skin disease. Its pathogenesis is multifactorial, and therapy can now be
directed at many of these factors. Among these factors are androgen hormones which play an important role in the
pathogenesis of acne. Accordingly, many antiandrogens have been developed to treat acne by systemic and topical ways.
Five-Alpha Avocuta 2% cream is a new topical 5-Alpha reductase inhibitor extracted from the tropical fruit “avocado”.
Objectives: To evaluate the effectiveness and safety of 5-Alpha Avocuta cream and compare it to tretinoin 0.025%
cream, in the treatment of acne vulgaris. Patients & Methods: This single blinded comparative study was done in
Department of Dermatology—Baghdad Teaching Hospital, from July 2009 through October 2010. All demographic
points related to the disease were obtained from each patient to evaluate severity of acne. Sixty-eight patients with acne
were divided into two groups and instructed to apply the drugs for three months. Group A uses 5-Alpha Avocuta 2%
(Teen-derm K) cream and Group B uses tretinoin (Acretin) 0.025% cream. Severe acne was excluded from the study.
The clinical improvement was evaluated by counting the number of inflammatory lesions before and after treatment and
compare between them by paired t-test. Results: Fifty-eight patients completed the study, their age ranged from 12 - 30
years with a mean of 18.21 ± 4.64 years. In Group A there was a significant reduction of the mean number of papules
from 29.7 before treatment to 15.5 after treatment (p < 0.0001), while the mean number of pustules decreased from 4.9
to 0.6 (p = 0.019). In Group B the mean number of papules was reduced from 28.5 to 14.9 (p < 0.0001), while the
mean number of pustules dropped from 5.3 before treatment to 0.7 after treatment (p = 0.009). The mean difference of
papules after 14 weeks in Group A was 15.55 ± 6.95 while in Group B, the mean difference was 14.86 ± 6.99. This
result was statistically not significant (p = 0.708, t-test). The difference in the mean percentage of reduction of
inflammatory lesions at week 14 between the two groups was not statistically significant (p-value = 0.999).The side
effect was negligible in Group A and not required stopping the drug while in Group B treatment stopped in 2 patients.
Conclusions: 5-Alpha Avocuta was an effective mode of therapy in treatment of acne vulgaris, and it was comparable
to tretinoin, with little side effects.
Keywords: Acne; 5-Alpha Avocuta; Tretinoin; Treatment; Iraq
1. Introduction
Acne vulgaris is an extremely common skin disorder
whose incidence peaks at 18 years of age, but substantial
numbers of men and women aged 20 - 40 years are also
affected by the disorder [1]. Although most patients im-
prove with time acne is a cause of suffering for many
young people; in addition it may lead to a life-long scar-
ring. Many therapies had been introduced to control acne
vulgaris which are based on etiological factors, these
drugs are either topical such as (erythromycin, clindamy-
cin, azaleic acid, benzyl peroxide and retinoic acid) or
systemic which include: Antibiotic such as tetracycline,
erythromycin, co-trimoxazole and others, oral retinoid and
hormonal therapy [2]. However many have side effects.
Topical treatments were sometimes associated with irri-
tation and systemic are not without unwanted effects and
precautions.
Acne patients, males and females secrete an average
more sebum than normal subjects; sebaceous activity is
*This study was an independent study and not funded by any of the
drug companies.
#Corresponding author.
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Treatment of Acne Vulgaris with 5-Alpha Avocuta Cream 2% in Comparison with Tretinion Cream 0.025%
(Single Blind Comparative Study)
180
predominantly dependent on androgen sex hormones of
gonadal or adrenal glands [3]. Since 5-Alpha Avocuta
reduces sebum secretion [4] it was tested in the present
study for the treatment of acne in comparison with to-
pical tretinoin.
So, this study was carried out to evaluate the effect-
tiveness and safety of 5-Alpha Avocuta cream and com-
pare it to tretinoin 0.025% cream, in the treatment of
acne vulgaris.
2. Patients and Methods
The single-blinded comparative clinical trial was con-
ducted at the Department of Dermatology in Baghdad
Teaching Hospital during the period from July 2009
through October 2010. Sixty-six patients participated in
the study however 8 patients defaulted for unknown rea-
sons and 58 completed the study.
Full history was taken from each patient including age,
duration of the disease, previous treatment and ensured
that every patient had stopped any systemic and topical
treatment at least 3 months before starting the present
therapy. Close physical examination was done to evalu-
ate the severity of acne. Scoring the severity of acne was
chosen according to P. Habif et al. [5].
1) Mild acne in which the count of papules is less than
10 and the count of pustules is less than 20;
2) Moderate acne in which the count of papules ranges
from 10 - 30 and the count of pustules ranged from 20 - 40;
3) Severe acne in which the count papules are more
than 30 and/or the count of pustules is more than 40.
Ethical approval was taken from the Scientific Council
of Dermatology and Venereology-Baghdad/Iraq before
the beginning with the study.
Formal consent was taken from each patient after full
explanation about the nature, course, treatment complica-
tion and prognosis of the disease.
Severe acne and nodulo-cystic types were excluded
from the study.
Digital photography was done for all patients (one
front and two side photos: Figures 1 and 2) at the first
visit and at each visit after, using Sony H50 nine mega
pixel digital cameras in a good illumination and same
place.
Patients were divided into two groups:
1) Group A:
In this group 29 patients were treated with topical 5-
Alpha Avocuta 2% creams (Teen Derm K@ Manufac-
tured by Modern cosmetic Co./Syria/Isis Pharmaceu-
ticals/France) twice daily application for 14 weeks.
2) Group B:
In this group 29 patients were treated with topical
tretinoin 0.025% cream (Acretin@ Manufactured by Jam-
(a) (b)
Figure 1. Twenty-eight years old female with 1 year history
of acne vulgaris on 5-Alpha Avocado for 14 weeks before (a)
and after (b) treatment.
(a) (b)
Figure 2. Seventeen years old female with 4 years history of
acne vulgaris on 5-Alpha Avocado for 14 weeks before and
after treatment.
jom Pharmaceuticals, Jeddah, Saudi Arabia), patient in-
structed to apply the cream at night for 2 hours, every an-
other day at the first 2 weeks and then daily overnight
thereafter.
Clinical evaluation of response to treatment was done
at week 2, 6, 10, 14. The assessment was carried out by
counting the inflammatory lesions (papules and pustules)
and recording any side effects. Follow up was carried out
for 2 months after stopping treatment.
Comparison of the mean difference in outcome after
14 weeks between two the groups was calculated in the
following:
The mean number of papules after treatment was de-
duced from the mean number before treatment for both
groups. The same was done for the number of pustules
for the 2 groups. These differences were then compared
in both groups.
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Treatment of Acne Vulgaris with 5-Alpha Avocuta Cream 2% in Comparison with Tretinion Cream 0.025%
(Single Blind Comparative Study)
181
Satisfaction of Patients to treatment was assessed as
such:
1) Full satisfaction;
2) Partial satisfaction;
3) No satisfaction.
All adverse events experienced during the trial were
recorded. Patients experiencing significant adverse events
were withdrawn from the study at the discretion of the
investigator. If severe irritation occurred, the dosing fre-
quency of study medication could be reduced to every
other night. If irritation was not alleviated by reduced
dosing frequency, a facial moisturizer chosen by the in-
vestigator was used.
All data were coded and entered to the computer by
using Microsoft Excel 2010 and Epi-info version 6. Com-
parison between all groups was done by using analysis of
variance. The number of lesions before and after treat-
ment in each group was compared using t-test and p-
value < 0.05 was considered to be significant.
3. Results
Fifty-eight patients completed the course of treatment (29
patients in each group). 5-Alpha Avocuta group in-
cluded 22 females and 7 males, their age ranged between
13 - 30 years with a mean of 20.24 ± 5.03 years, while
tretinoin group included 21 females and 8 males, their
age ranged between 12 - 28 years with a mean of 19.03 ±
4.24 years.
In 5-Alpha Avocuta group there was a significant re-
duction of the mean number of papules from 29.7 before
treatment to 15.5 after treatment (p < 0.0001). While the
mean number of pustules decreased from 4.9 to 0.6 (p =
0.019). See Table 1. In tretinoin group the mean number
of papules was reduced from 28.5 to 14.9 (p < 0.0001),
while the mean number of pustules dropped from 5.3
before treatment to 0.7 after treatment (p = 0.009). See
Table 2. The mean percentage of reduction of inflamma-
tory lesions over the treatment period was 33.8%, 44.3%,
and 51.529% at week 6, 10 and 14 respectively. Regard-
ing tretinoin group the mean percentage of reduction of
Table 1. Mean and SD of number of papules and pustules
before and after treatment with 5-Alpha Avocuta.
Pustules Papules
After Before After Before
Mean
0.62 4.93 15.55 29.72
SD
1.44 2.85 6.95 9.66
Variance
2.10 8.13 48.32 93.49
p-value
0.019 <0.0001
t-test
6.701 0.240968604
Table 2. Mean and SD of number of papules and pustules
before and after treatment with Tretinoin.
Pustules Papules
After Before After Before
Mean
0.72 5.344 14.86 28.51
SD
1.19 3.02 6.99 8.06
variance
1.42 9.16 48.90 65.11
p-value 0.008 <0.0001
t-test
4.32432E–09 5.84099E–09
inflammatory lesions was 38.7%, 47.1%, and 51.522% at
week 6, 10 and 14 respectively. The mean difference of
papules after 14 weeks in group A was 15.55 ± 6.95
while in tretinoin group; the mean difference was 14.86 ±
6.99. This result was statistically not significant (p =
0.708, t-test) Table 1. The mean difference of pustules
after 14 weeks in 5-Alpha Avocuta was 0.62 ± 1.44
while in group B the mean difference was 0.724 ± 1.19.
This result was statistically not significant (p = 0.766,
t-test) Table 2.
The difference in the mean percentage of reduction of
inflammatory lesions at week 14 between the two groups
was not statistically significant (p-value = 0.999).
Twenty (68.9%) patients in 5-Alpha Avocuta group
were fully satisfied and six (20.7%) patient showed par-
tial satisfaction and three (10.3%) patients were not satis-
fied. In tretinoin group nineteen (65.5%) patients were
fully satisfied and six (20.6%) patients showed partial
satisfaction and four (13.7%) patients were not satisfied.
Regarding side effects in 5-Alpha Avocuta group one
patient (3.4%) had mild facial erythema and one patient
(3.4%) had burning sensation which both didn’t required
stop the treatment. While in tretinoin group three patients
(10.3%) had mild-moderate facial erythema, one patient
(3.4%) had dryness, one patient (3.4%) had mild peeling,
two patients (6.8%) had burning sensation, and three
patients (10.3%) had itching, treatment stopped in two
patients because of erythema and itching and then it was
re-introduced after two weeks.
4. Discussion
Five-Alpha Avocuta is an original patented active ingre-
dient derived from avocado pears, it inhibits 5-Alpha-
reductase type I activity with proven efficiency on hu-
man scalp and skin disorders related to hyper-sebor-
rhoea [4]. Avocado used as: anti-inflammatory (in the
treatment of psoriasis combined with vitamin B12 in a
cream) [6], management of cutaneous disorders associ-
ated with itchy and dry skin (anti-itching) [7], reduce
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Treatment of Acne Vulgaris with 5-Alpha Avocuta Cream 2% in Comparison with Tretinion Cream 0.025%
(Single Blind Comparative Study)
182
UVB-induced damage and inflammation in skin. [8], and
as Effective inducer of cutaneous defensive functions in
atopic dermatitis [9].
However the only study about the efficacy of 5-Alpha
Avocuta a multi-centric clinical evaluation, under derma-
tologist control, was conducted on 27 volunteers by Pic-
cardi N. et al. who concluded that after 3 weeks of twice
daily application it was able to reduce the sebum produc-
tion of the face and to reduce the number of open come-
dons [4].
In the present study 5-Alpha Avocuta was investigated
in the treatment of 58 patients with inflammatory acne in
comparison with a well-known topical anti-acne medica-
tion (tretinoin). Good response to treatment with avocuta
was evident in 58% of our patients after 14 weeks of
treatment; this was comparable to patients treated with
tretinoin. There was no statistically significant difference
regarding the reduction in the number of papules and
pustules between patients treated with avocuta and those
treated with tretinoin. However 5-Alpha Avocuta was
better tolerated, it was not necessary to stop the therapy
in any patient. Two patients showed mild side effects;
one patient had mild facial erythema and one patient had
burning sensation, while in the tretinoin group ten patient
showed side effects in the form of erythema, dryness,
burning sensation and itching. Patients applied avocuta
cream overnight on a daily base from the start while with
tretinoin cream patients were asked to apply it every
other day in the begging and for 2 hours and then to in-
crease the duration and frequency of application later to
avoid irritation.
On comparing our results with other studies Shalita et
al. compared adapalene gel 0.1% and tretinoin gel
0.025% in the treatment of acne vulgaris in a multi-cen-
ter trial. After 12 weeks of treatment there was a 48%
reduction in the number of inflammatory lesions with
adapalene and 38% with tretinoin. Side effects in the
form of erythema and burning were also noted in their
patients [10]. While in the present study there was
51.229% reduction of the mean percentage of inflamma-
tory lesions in those treated with 5-Alpha Avocuta and
51.522% reduction of the mean percentage of inflamma-
tory lesions in those treated with tretinoin at week 14.
Burke et al. conducted a double-blind clinical study in
94 subjects comparing benzoyl peroxide 5% cream and
erythromycin 1.5% lotion. There was a significant re-
ducetion in the inflammatory lesions starting at the 4th
week of treatment and more pronounced at the 8th week.
Both benzoyl peroxide and erythromycin produced a
reduction in total inflammatory lesions at the 4th and 8th
weeks (the benzoyl peroxide by 33% and 37% and the
erythromycin by 42% and 39% subsequently) [11]. How-
ever side effects in the form of erythema and itching
were noticed in both groups. One patient on benzoil per-
oxide developed dermatitis [11]. While in our work both
5-Alpha Avocuta and tretinoin produced a reduction in
total inflammatory lesions at the 6th and 10th week (the
5-AA by 33.88% and 44.83%, and the tretinoin by 38.75%
and 47.14%). These changes were significant at the 6th
and the 10th weeks for both preparations.
Finestride 0.01% solution was compared to clindamy-
cin 1.5% solution by Matloob et al. [12]. Both formula-
tions were found to be effective in reducing the number
of acne lesions. Side effects were few. However fine-
stride is contraindicated in women in the child bearing
age.
The mode of action of 5-Alpha Avocuta is not well
known, however, it could be attributed to its effects on
hyper-seborrhea. The drug was shown to reduce sebum
production in a controlled trial [4]. Also it can inhibit
5-Alpha reductase enzyme (type-1) thus inhibiting pe-
ripheral testosterone conversion [4].
The present work, showed that 5-Alpha Avocuta is an
effective drug in the treatment of acne vulgaris especially
in mild and moderate acne and was comparable to topical
tretinoin with few side effects.
To the best of our knowledge and as revealed from our
search of the medical literature, this is the first study which
investigated the use of 5-Alpha Avocuta in the treatment
of acne vulgaris.
In conclusion, 5-Alpha Avocuta approved as an effec-
tive safe easily applied remedy for treatment of mild and
moderate acne vulgaris with negligible side effects.
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