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Research Article
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Efficacy of 10% Azelaic Acid Gel with Hydro-alcoholic or Alcohol-free Bases
in Mild to Moderate Acne Vulgaris; the First Clinical Trial |
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Effat Khodaeinai,
Shahla Babaeinejad,
Mehdi Amirnia,
Javad Shokry,
Elham Razzagh Karimi,
Daniel F. Fouladi
and
Kamran Sedaghat
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ABSTRACT
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Azelaic Acid is a very effective topical medication for treating acne vulgaris.
This study aims to compare the efficacy of 10% azelaic acid gel with hydro-alcoholic
and alcohol-free bases in mild-to-moderate acne vulgaris. This randomized, double
blind, clinical trial, 40 patients with mild-to-moderate acne vulgaris were
recruited from Sina Hospital from November 2009 through March 2011. They randomized
in two equal age and sex-matched groups, receiving 10% azelaic acid gel with
either hydro-alcoholic base or alcohol-free base once at night on their face
for eight consecutive weeks. All the patients were revisited on weeks 1, 2,
4, 6 and 8 after treatment and facial acne lesions were counted on each session.
Possible complications, as well as the effect of skin type were investigated.
Total, inflammatory and noninflammatory acne lesion counts decreased significantly
in both groups by the end of study period. However, there was no significant
difference between the two groups in this regard (p<0.05). There were minor,
self-limited complications, including 3 cases of mild itching in both groups.
For the count of inflammatory lesions, azelaic gel with alcoholic base was significantly
more effective than azelaic gel with alcohol-free base in patients with oily
facial skin (p = 0.02). All the patients (100%) were very satisfied with their
treatments. In conclusion, both 10% azelaic gels with hydro-alcoholic and alcohol-free
bases were comparably effective against mild-to-moderate acne vulgaris. In patients
with oily skin, however, 10% azelaic acid with hydro-alcoholic base was superior
to the medication with alcohol-free base in patients with oily skin.
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How
to cite this article:
Effat Khodaeinai, Shahla Babaeinejad, Mehdi Amirnia, Javad Shokry, Elham Razzagh Karimi, Daniel F. Fouladi and Kamran Sedaghat, 2014. Efficacy of 10% Azelaic Acid Gel with Hydro-alcoholic or Alcohol-free Bases
in Mild to Moderate Acne Vulgaris; the First Clinical Trial. Journal of Medical Sciences, 14: 87-91. DOI: 10.3923/jms.2014.87.91 URL: https://scialert.net/abstract/?doi=jms.2014.87.91
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Received: October 15, 2013;
Accepted: November 09, 2013;
Published: January 16, 2014
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INTRODUCTION
Acne vulgaris is a very common skin disease all over the world. Patients are
usually adolescents and young adults. Although there are diverse options in
treating acne vulgaris (Babaeinejad et al., 2011;
Fouladi, 2012; Khodaeiani
et al., 2012, 2013; Babaeinejad
and Fouladi, 2013), the first-line in mild-to-moderate disease includes
topical medications (Gollnick and Krautheim, 2003;
Krautheim and Gollnick, 2004; Firooz
and Fouladi, 2012). Azelaic acid is a natural dicarboxylic acid with known
antibacterial, anti-inflammatory and anti-proliferative properties (Fleischer,
2006; Gupta and Gover, 2007). This is a safe medication
with no prominent systemic complications or teratogenic effects. No photodynamic
reaction has been ever observed in using azelaic acid. With high rate of tolerance
among consumers, no significant induction of bacterial resistance has been reported
with this medication (Graupe et al., 1996). In
acne vulgaris, in particular, azelaic acid prohibits growth of propionibacterium
acne through inhibiting protein synthesis. In addition, this compound prevents
follicular keratinization, which in turn inhibits comedone formation (Fluhr
and Degitz, 2010). Antiproliferative effect of azelaic acid on hyperactive
or abnormal but not normal melanocytes leads to prevention of skin hyperpigmentation
(Healy and Simpson, 1994). It has been shown that azelaic
acid prevents aggregation of propionibacterium acne, diminishes abnormal shedding
of cells in the pilosebaceous ducts and ameliorates inflammation in acne patients
(Thiboutot, 2000). Overall, azelaic acid is effective
against both inflammatory and noninflammatory lesions of acne vulgaris (Graupe
et al., 1996). The present study aims to investigate the efficacy of
10% azelaic acid gel in patents with mild-to-moderate acne vulgaris, with emphasis
of comparing compounds with hydro-alcoholic and alcohol-free bases for the first
time in the literature.
MATERIALS AND METHODS
In this randomized, double blind, clinical trial, 123 patients with mild-to-moderate
acne vulgaris (acne grade I-III) (Burke and Cunliffe, 1984)
were studied in Tabriz Teaching Sina Hospital from November 2009 through March
2011. This study was approved by the ethics committee of Tabriz University of
Medical Sciences. Informed written consents were obtained from the participants.
The exclusion criteria were using medications such as contraceptives containing
antiandrogens, systemic or topical steroids and systemic or topical antibiotics
within 30 days before enrollment and documented sensitivity to azelaic or similar
compounds. Using Randlist software (ver. 1.2), the patients were randomized
into two groups, receiving 10% azelaic acid gel with either hydro-alcoholic
base or alcohol-free base once at night on their face for eight consecutive
weeks. Azelaic gels were prepared by a pharmacist noninvolved in the study.
The medication was filled in similar tubes, which were marked as A
or B. The contents were revealed only after data analysis. All the
patients were revisited on weeks 1, 2, 4, 6 and 8 after topical treatment commencement
and high-quality photographs were taken from their face in each session. Total
number of inflammatory and noninflammatory facial acne lesions were counted
and compared with the counts at baseline. Possible complications and final patients
satisfaction were documented, as well. The facial skin type (oily, non-oily)
was determined by using a standard sebumeter (Sebumeter® SM 815, Courage
and Khazaka, Cologne, Germany) according to available guidelines (Khodaeiani
et al., 2012). All the patients were instructed to avoid sun exposure,
strenuous exercises and using particular foods/medications during the study
period (Fouladi, 2012). Within the study period, 43
patients dropped out of the study due to noncompliance (16), using other medications
(16), irregular visits (9) and miscellaneous causes (2); leaving 40 patients
in each group.
Statistical analysis: The SPSS Software for Windows (ver.16.0, SPSS
Inc., IL, USA) was used for analysis. Independent samples t test and the Chi-square
(χ2) or Fishers exact tests were used. A p-value ≤0.05
was considered statistically significant.
RESULTS
Patients characteristics and general data are summarized in Table
1. The two groups were comparable in terms of sex, age, skin type and family
history of acne vulgaris. The total count of acne lesions decreased significantly
in both groups within 8 weeks of treatment (p<0.001) (Fig.
1).
Table 1: |
Demographic and other variables in the studied patients with
mild-to-moderate acne vulgaris |
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Data are presented as mean±standard deviation or frequency
(%), p<0.05 is significant |
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Fig. 1: |
Total count of facial acne lesions in the studied groups with
acne vulgaris |
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Fig. 2: |
Percentage resolution of total facial acne lesions in the
studied groups with acne vulgaris |
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Fig. 3: |
Count of facial inflammatory acne lesions in the studied groups
with acne vulgaris and oily skin |
Percentage resolution of total acne lesions in both groups is shown in Fig.
2. There was no significant difference between the two groups in this regard
(p = 0.17). The count of noninflammatory acne lesions decreased significantly
in both groups by the end of study period (p<0.001); however, there was no
significant difference between the two groups in this regard (p = 0.46). Similar
trend was also present for the count of inflammatory acne lesions, which decreased
significantly in both groups (p<0.001), with no significant inter-group difference
(p = 0.15). Hyperpigmentation of previous acne lesions ameliorated significantly
in both groups by the end of study (p<0.001), with no significant difference
between the two groups (p = 0.64). No effect was seen on old scars.
Regarding complications, there was only one case (2.5%) with mild itching in
the patients who received azelaic gel with alcoholic base and 2 cases (5%) with
mild itching in the other group (p = 0.50). All the patients in both groups
(100%) were very satisfied with the results of their treatment.
Comparing overall outcome of treatment in patients with oily and non-oily facial
skin, no significant difference was found (p = 0.81). Similarly, there was no
significant difference between the patients with oily and non-oily facial skin
in terms of the count of noninflammatory acne lesions (p = 0.27). For the count
of inflammatory lesions, however, azelaic gel with alcoholic base was significantly
more effective than azelaic gel with alcohol-free base in patients with oily
facial skin (p = 0.02) (Fig. 3).
DISCUSSION
The first line in treating mild-to-moderate acne vulgaris is using topical
medications. Antibiotics play a pivotal role in this regard. However, emerging
bacterial resistance has dramatically limited their liberal use in acne vulgaris
(Bojar et al., 1993; Simpson,
2001; Bettoli et al., 2006). In the present
work, efficacy of 10% azelaic gel with hydro-alcoholic or alcohol-free base
was examined in patients with mild-to-moderate acne vulgaris. Accordingly, both
preparations were similarly effective against inflammatory and noninflammatory
acne lesions (Fig. 1 and 2). This is line
with results of previous studies that showed high efficacy of 20% azelaic gel
in acne vulgaris (Fitton and Goa, 1991; Graupe
et al., 1996; Gollnick et al., 2001;
Iraji et al., 2007). Gupta
and Gover (2007) also reported effectiveness of 15% azelaic gel in treating
facial inflammatory lesions. To the best of our knowledge, however, this is
the first study that examined the efficacy of 10% azelaic gel in these patients.
Pazoki-Toroudi et al. (2010) showed that combination
of 5% azelaic and 2% erythromycin gels is as effective as a combination of 20%
azelaic and 2% erythromycin gels in treating mild-to-moderate acne vulgaris.
According to the results of the present study, however, 10% azelaic acid gel
can be effectively used alone in such patients. Thiboutot
(2008) showed that 10% azelaic acid is as effective as benzoyl peroxide
in acne patients. They concluded that due to higher satisfactions of patients
toward azelaic acid, it is superior to similar medications. All the patients
in the present study were also completely satisfied with the results of their
treatment. This is also in conformity with the results of another study by Gollnick
and Krautheim (2003) that concluded many anti-acne medications can be replaced
by azelaic acid. Lack of bacterial resistance against this medication was another
suggested preference of azelaic acid over similar medications in this report.
Furthermore, unlike many famous ant-acne medications, azelaic acid is safe in
pregnant and lactating patients (Fluhr and Degitz, 2010).
In the present work, there was not a significant difference between azelaic
acid with hydro-alcoholic or alcohol-free base against acne lesions. However,
the medication with hydro-alcoholic base was significantly more effective against
inflammatory lesions in patients with oily skin. This difference may be attributed
to pharmacodynamic specifications or the ability of medication in solving oily
layer of the skin in patients with oily skin and hence, more facilitated access
to inflammatory lesions, which are more frequent in such patients comparing
with those with normal or dry skin type (Khodaeiani et
al., 2012). Finally, both medications were along with minor complications,
i.e., mild itching in the site of application only in 2.5 and 5% of the patients
in two groups. Significant complications have been reported as the major source
of patient=s non-adherence to any medication, particularly in young patients
with acne vulgaris (Khodaeiani et al., 2013).
CONCLUSION
Both 10% azelaic gels with hydro-alcoholic and alcohol-free bases are comparably
effective against mild-to-moderate acne vulgaris. In patients with oily skin,
however, 10% azelaic acid with hydro-alcoholic base is superior to the medication
with alcohol-free base in patients with oily skin.
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