Safety and Efficacy of Low-Dose Isotretinoin in The Treatment of Moderate To Severe Acne Vulgaris

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Safety and Efficacy of Low-Dose Isotretinoin in the Treatment of
Moderate to Severe Acne Vulgaris
Indian J Dermatol. 2014 May-Jun; 59(3): 316.
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Indian Journal of Dermatology <http://dx.doi.org/10.4103/0019-5154.131455>
Medknow Publications
Safety and Efficacy of Low-Dose Isotretinoin in the Treatment of
Moderate to Severe Acne Vulgaris
Parinitha K Rao, Ramesh M Bhat, [...], and Ganesh H Kamath
Additional article information <#__ffn_sectitle>
Abstract
Background:
Isotretinoin is indicated for moderate to severe cases of acne which are
unresponsive to conventional therapy. The classical recommended dose is
0.5 to 1.0 mg/kg/day. As the side effects are dose related, low-dose
isotretinoin therapy for acne is an attractive option; however, but
little data exists on the safety and efficacy of this strategy.
Materials and Methods:
In this prospective, non-comparative study, 50 participants, both male

and female, having moderate to severe acne vulgaris were enrolled and
treated with isotretinoin at a dose of 20 mg/day (approximately 0.3-0.4
mg/kg/day), for a period of 3 months. Participants were evaluated by
means of clinical and laboratory investigations before starting
isotretinoin. Investigations were repeated at the end of the first and
third months following completion of treatment, and participants were
followed up for 6 months to look for any relapse.
Results:
At the end of the treatment, very good results were observed in 90% of
participants. Cheilitis was the most common among the side effects
observed and was seen in 98% of the participants. One participant
developed vitiligo as a side effect, which is a new finding, and has not
reported in literature before. Elevated serum lipid levels were observed
in 6% of the participants, and relapse occurred in 4% of the
participants over a 6 month follow up period.
Conclusion:
Three months of treatment with low-dose isotretinoin (20 mg/day) was
found to be effective in the treatment of moderate to severe acne
vulgaris, with a low incidence of serious side effects. This dose also
was more economical than the higher doses.
*Keywords: */Acne/, /low-dose isotretinoin/, /safety and efficacy/
Introduction
*What was known?*
Isotretinoin is known to cause most of its side effects at a higher
dose(0.5-1 mg/kg/day) which is the classical recommended dose. As the
side effects are dose related, low-dose (0.3-0.4 mg/kg/day) of
isotretinoin seems to be an attractive option, but little data exists on
the safety and efficacy of this strategy.
Acne is a chronic inflammatory disease of the pilosebaceous units, and
is primarily seen in adolescents. It can have a significant
psychological and social impact. Most cases of acne present with a
pleomorphic variety of lesions consisting of comedones, papules,
pustules and nodules, and in some cases are accompanied by scarring.[1
<#ref1>] Retinoids are a key component of anti-acne therapy. The
introduction of isotretinoin, a first generation synthetic retinoid, for
the treatment of patients with moderate to severe acne vulgaris is
regarded as a major therapeutic advance in dermatology.[2 <#ref2>]
Isotretinoin is indicated for severe acne and moderate cases of acne
that are unresponsive to conventional therapy. The classical recommended
dose is 0.5 to 1.0 mg/kg/day for 4 to 8 months. As the side effects are
dose related, the idea of low-dose isotretinoin therapy for acne is
attractive; however, little data exists on the safety and efficacy of
this strategy in Indian participants.[3 <#ref3>] We have undertaken this
study to evaluate the safety and efficacy of low-dose isotretinoin in
the treatment of moderate to severe acne vulgaris, and thus determine an
effective modality of treatment with a low incidence of severe side
effects, in a more cost effective manner.

Materials and Methods
Source of data
A total of 50 participants diagnosed as having moderate to severe acne
vulgaris, and attending the dermatology Out Patient Department (OPD) at
Fr. Muller Medical college Hospital, Mangalore, were studied. The
participants were recruited over a period of two years, from September
2009 to September 2011, and were followed up for three months to know
the safety and efficacy of low-dose isotretinoin in the treatment of
moderate to severe acne vulgaris.
Methods of collection of data
In this prospective non-comparative study, 50 participants having
moderate to severe acne vulgaris were selected after taking an informed
written consent using purposive sampling technique. The participants
diagnostic and clinical data including age, sex, site of acne, duration
and severity of acne and indications for isotretinoin therapy was noted
down. The initial assessment of acne was done using the global acne
grading system (GAGS) [Table 1
</pmc/articles/PMC4037971/table/T1/?report=objectonly>].[4 <#ref4>] This
system divides the face, chest and back into six areas (forehead, each
cheek, nose, chin, chest and back) and assigns a factor to each area on
the basis of size. Baseline investigations including complete blood cell
counts, liver function tests, lipid profile and urine pregnancy test
(for female participants of child bearing potential) were done before
starting the participant on isotretinoin, and follow up investigations
were carried out at the end of first and third month following
completion of the treatment. Female participants were started on
treatment only after their next menstrual period to ensure that they are
not pregnant at the time of initiation of the treatment. The
participants were also followed up for 6 months after completion of
treatment to look for any relapse. The dose of isotretinoin used was 20
mg/day over a period of 3 months. The response to treatment was
evaluated at end of 1 month and at the end of 3 months following
completion of treatment and, was assessed on scales 0-4.
Table 1 </pmc/articles/PMC4037971/table/T1/?report=objectonly>
Global acne grading system
Scale definition
*
*
*
*
*
0 completely cleared 100% lesion clearance

1 marked improvement > 75% lesion clearance
2 moderate improvement 50-75% lesion clearance
3 mild improvement 25-50% lesion clearance
4 insignificant improvement < 25% lesion clearance
The efficacy of the drug was assessed by lesion counts at each visit.
The participants were also evaluated for safety and efficacy of the drug
on each follow up visit.
Data analysis
Data was analyzed by the Friedman test and /t/-test and Statistical
Package for Social Sciences (SPSS)-version 13 software was used to
generate the analysis.
Inclusion criteria
*
*
*
Age above 12 years and of both the sexes

Participants having moderate to severe facial acne vulgaris
Participants willing to undergo treatment and follow ups
Exclusion criteria
*
*
*
*
*
*
Age less than 12 years

Participants having mild facial acne vulgaris
Pregnant women and women who intend to become pregnant during the
course of treatment
Participants who intend to consume alcohol during the treatment course
Presence of any renal or hepatic compromise or any pre-existing
hyperlipidemia
Participants not willing for the necessary investigations
Results
Out of the total number of 50 participants, 38 participants (76%) were

males and 12 participants (24%) were females. There was an overall male
preponderance, the male to female ratio being 3.1:1. Majority of the
participants, 35 in number (70%), were in the age group of 21-30 years,
the mean age calculated as 26.36 years (Standard Deviation, S.D-5.90).
Nodulocystic acne was the most common indication for treatment and was
seen in 22 participants (44%), followed by the reason of acne being
resistant to treatment in 20 participants (40%), and frequent relapses
in 8 participants (16%). On cutaneous assessment, it was found that at
week 0, 6 participants (12%) had grade II acne, 28 participants (56%)
had grade III acne and 16 participants (32%) had grade IV acne. At the
end of 12 weeks, that is, on the completion of treatment, 3 participants
(6%) had grade 0 acne, 45 participants (90%) had grade I acne and 2
participants (4%) had grade II acne. During the follow up after 6
months, it was found that 3 participants (6%) had grade 0 acne, 44
participants (88%) had grade I acne, 2 participants (4%) had grade II
acne and 1 participant (2%) had grade III acne. Relapse was seen in 2
participants (4%); 1 participant falling in the range of grade I to

grade II acne, and 2^nd participant in the range of grade II to grade
III acne [Table 2
</pmc/articles/PMC4037971/table/T2/?report=objectonly>]. A significant
reduction in the grade of acne was found at the end of treatment, and
the reduction in the grade of acne was found to be statistically
significant (Friedman Test, ^2 = 146.23, /P/ < 0.0001, Highly
Significant) [Table 3
</pmc/articles/PMC4037971/table/T3/?report=objectonly>]. At the end of
12 weeks post treatment, 3 participants (6%) had 100% lesion clearance
(scale 0), 45 participants (90%) had > 75% lesion clearance (scale 1)
and 2 participants (4%) had 50-75% lesion clearance (scale 2) [Table 4
</pmc/articles/PMC4037971/table/T4/?report=objectonly>] [Figures
[Figures1a1a </pmc/articles/PMC4037971/figure/F1/?report=objectonly>,
,bb </pmc/articles/PMC4037971/figure/F1/?report=objectonly> and and2a2a
</pmc/articles/PMC4037971/figure/F2/?report=objectonly>, ,bb
</pmc/articles/PMC4037971/figure/F2/?report=objectonly>].
Grade of acne in the patients in the study
Results-grade of acne in the patients in the study at the end of treatment
Post treatment-scale of acne in the patients in the study
Figure 1 </pmc/articles/PMC4037971/figure/F1/?report=objectonly>
(a) Pretreatment photograph (b) Post treatment photograph
The adverse effects observed on treatment with isotretinoin were as follows:
Cheilitis was the most common among the adverse effects observed, and
was seen in 49 participants (98%) [Figure 3a
</pmc/articles/PMC4037971/figure/F3/?report=objectonly>], followed by
Xerosis in 42 participants (84%), dandruff in 6 participants (12%),
erythema of the face [Figure 3b
</pmc/articles/PMC4037971/figure/F3/?report=objectonly>] and hair rough
and dry in 4 participants each (8%), dryness of mouth, abnormal levels
of total cholesterol and serum triglycerides, abnormal levels of liver
enzymes in 3 participants each (6%). Hair loss and headache were
observed in 2 participants (4%). One participant (2%) developed lesions
of vitiligo. [Figure 3c
</pmc/articles/PMC4037971/figure/F3/?report=objectonly> and Table 5
</pmc/articles/PMC4037971/table/T5/?report=objectonly>]. When the lab
investigations were performed, a significant increase was seen in the
level of total cholesterol and serum triglycerides, and a raise above
normal values was seen in 3 participants (6%). There was a significant
increase in the level of liver enzymes before and after treatment and a
raise above normal values was seen in 3 participants (6%). However, no
significant changes were observed in the levels of hemoglobin, white
blood cells count and platelet count before and after treatment [Table 6
</pmc/articles/PMC4037971/table/T6/?report=objectonly>].
(a) Side effect: Cheilitis (b) Side effect: Erythema of the face (c)
Side effect: Development of vitiligo in a patient in the study
Side effects observed in the patients in the study
Results of Lab investigations of the patients in the study
Discussion
Several studies have been conducted to study the safety and efficacy of
low-dose isotretinoin in the treatment of moderate to severe acne
vulgaris.[3 <#ref3>,5 <#ref5>,6 <#ref6>,7 <#ref7>,8 <#ref8>,9 <#ref9>,10
<#ref10>] In a study conducted by Amichai /et al/.,[3 <#ref3>] good
results were seen in 93% of the participants and relapse was seen in 4%
of the participants. Cheilitis was the most commonly observed side
effect and was seen in 91% of the participants. Abnormal values of liver
enzymes were observed in 4.8% of the participants and abnormal serum
lipid values were observed in 4.2% of the participants. The results
obtained in our study was similar to the study done by Amichai /et
al/.[3 <#ref3>] In our study, excellent results were seen in 6% of the
participants, very good results were seen in 90% of the participants and
relapse was observed in 4% of the participants. Chelitis was the most
common among the side effects observed, and was seen in 98% of the
participants, with abnormal values of liver enzymes in 6% of the
participants and abnormal values of serum lipids in 6% of the
participants. An analysis of the studies revealed that due to the
intrinsic superlative efficacy of isotretinoin in acne, the efficacy was
as high as 88.52%, and a mean of 90% efficacy was maintained.[11
<#ref11>,12 <#ref12>,13 <#ref13>] Thus, the comparative analysis can be
logically based on the dose of isotretinoin discounting the varying
protocols. In conclusion, the efficacy of the drug ranged from 69 to
99%.[5 <#ref5>,6 <#ref6>,7 <#ref7>,8 <#ref8>,9 <#ref9>,10 <#ref10>,11
<#ref11>,12 <#ref12>,13 <#ref13>,14 <#ref14>] There was no difference
between the weekly and the daily/alternate day regimens.[8 <#ref8>,9
<#ref9>] In our study, the efficacy of isotretinoin in the treatment of
moderate to severe acne vulgaris was found to be 90%.
Hermes /et al/.,[6 <#ref6>] (8.3 months; 10 mg/d up to 0.43 mg/kg)
reported very good results in 62.8% and good results in 31.9% of the
participants. Mandekou-Lefaki /et al/.,[10 <#ref10>] achieved excellent
results in 68% and fair to good results in 31.2% (dose of 0.15-0.4
mg/kg/d; 8 months). In a study from India,[9 <#ref9>] a low-dose
isotretinoin treatment (0.15-0.28 mg/kg/d) lead to clinically
significant results in 87.54% of the participants, including 68.20% very
good and 19.34% of good results. However in our study, excellent results
were seen in 6% of the participants, and very good results were seen in
90% of the participants (20 mg/d up to 3 months).
Goulden /et al/.[15 <#ref15>] followed their participants for four
months and stated that 85% were free of acne during this period.
Nonetheless, two points of the isotretinoin therapy cannot be ignored:
1) Slow response to treatment, and 2) Flare-up of the lesions. Some
researchers believe that macrocomedones and nodules are the most common
factors showing the slow response and flare ups. The flare-up (defined
as the worsening of lesions, mandating prescription of prednisolone)
rate was found to be zero in the study. Similarly, in our study there
was no flare up of acne following treatment with low-dose isotretinoin.
Our study demonstrated that the adverse effects of isotretinoin were not
serious and could be treated by conservative measures in most instances.
In a study done by Zane /et al/.,[16 <#ref16>] it was observed that
among the side effects, Cheilitis was the most common and occurred in
76% participants, followed by xerosis in 24% participants. Laboratory
parameters had little alterations with limited rise in total
cholesterol, serum triglyceride and liver enzyme levels. Abnormalities
in hematological tests were not seen. These results were similar to the
results obtained in our study, where cheilitis was the most common side
effect observed in 98% of the participants, followed by xerosis in 84%
of the participants. Abnormal values of liver enzymes and serum lipids
were seen in 6% of the participants for each category and no
abnormalities in the hematological tests were seen. One participant in
our study developed lesions of vitiligo during the course of treatment
with isotretinoin. This was a new finding which has not been reported in
any of the previous studies with low-dose isotretinoin.
Previous studies have shown that treatment with isotretinoin can cause
many adverse psychiatric effects including depression, psychosis, mood
swings, violent behavior, suicide and suicide attempts.[17 <#ref17>]
However, in our study no such adverse psychiatric effects were observed.
On comparison with previous studies of low-dose isotretinoin in acne, it
was observed that the efficacy of low-dose isotretinoin in the treatment
of acne, varied from 69% to 99%, and the relapse rate varied from 5% to
39% [Table 7 </pmc/articles/PMC4037971/table/T7/?report=objectonly>].[3
<#ref3>,5 <#ref5>,6 <#ref6>,7 <#ref7>,8 <#ref8>,9 <#ref9>,10 <#ref10>,12
<#ref12>,14 <#ref14>,15 <#ref15>] However in the present study, the
efficacy of low-dose isotretinoin in the treatment of moderate to severe
acne vulgaris was found to be 90%, and the relapse rate was found to be
4% over a follow up period of 6 months.
Comparison of previous studies carried out with low-dose isotretinoin
Very few studies which highlight the safety and efficacy of low-dose
isotretinoin in acne have been published in Indian literature. In an
Indian study published by Sardana /et al/. the in Journal of European
Academy of Dermatology Venereology and Leprosy, a fixed dose of 20 mg
isotretinoin was administered for a duration of 24 weeks along with
topical clindamycin.[9 <#ref9>] In two other studies, different doses of
isotretinoin and addition of azithromycin were used, respectively.[18
<#ref18>,19 <#ref19>] In our study the drug was administered daily for a
duration of 12 weeks without any topical medication. We also observed
vitiligo in one patient as a side effect during the treatment, which is
a new observation and hasnt been reported before.
Conclusion
vulgaris. The benefits accrued to the society from using isotretinoin
outweigh the risks, and thus low-dose isotretinoin can be used in the
treatment of moderate to severe acne vulgaris as an effective modality
of treatment, with a low incidence of severe side effects and at a
lesser cost. We recommend judicious use of low-dose isotretinoin in
patients with moderate to severe acne, because acne not only scars the
face, but also the mind and the heart.
*What is new?*
vulgaris, with a low incidence of serious side effects. This dose also
was more economical than the higher doses.
Footnotes
*Source of Support:* Nil
*Conflict of Interest:* Paper was presented at the World Congress of
Dermatology (WCD) 2011, Seoul. WCD 2011 Scholarship Awardee
Article information
Indian J Dermatol. 2014 May-Jun; 59(3): 316.
doi: 10.4103/0019-5154.131455
<http://dx.doi.org/10.4103%2F0019-5154.131455>
PMCID: PMC4037971
Parinitha K Rao </pubmed/?term=Rao%20PK%5Bauth%5D>,^Ramesh M Bhat
</pubmed/?term=Bhat%20RM%5Bauth%5D>,^^B Nandakishore
</pubmed/?term=Nandakishore%20B%5Bauth%5D>,^Sukumar Dandakeri
</pubmed/?term=Dandakeri%20S%5Bauth%5D>,^Jacintha Martis
</pubmed/?term=Martis%20J%5Bauth%5D>,^and Ganesh H Kamath
</pubmed/?term=Kamath%20GH%5Bauth%5D>^
/From the Department of Dermatology, Father Muller Medical College,
Mangalore, Karnataka, India/
/*Address for correspondence:* Dr. Ramesh M. Bhat, Department of
Dermatology, Father Muller Medical College, Kankanady, Mangalore - 575
002, Karnataka, India. E-mail: moc.oohay@amredhsemar <mailto:dev@null>/
Received May 2012; Accepted February 2013.
Copyright </pmc/about/copyright.html> : Indian Journal of Dermatology
This is an open-access article distributed under the terms of the
Creative Commons Attribution-Noncommercial-Share Alike 3.0 Unported,
which permits unrestricted use, distribution, and reproduction in any
medium, provided the original work is properly cited.
Articles from Indian Journal of Dermatology are provided here courtesy
of *Medknow Publications*
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Table 1
An external file that holds a picture, illustration, etc. Object name is
IJD-59-316c-g001.jpg
Global acne grading system

Table 2
Grade of acne in the patients in the study
Table 3
Results-grade of acne in the patients in the study at the end of treatment
Table 4
Post treatment-scale of acne in the patients in the study
Figure 1
Figure 2
Figure 3
(a) Side effect: Cheilitis (b) Side effect: Erythema of the face (c)
Side effect: Development of vitiligo in a patient in the study
Table 5
Side effects observed in the patients in the study
Table 6
Results of Lab investigations of the patients in the study
Table 7
Comparison of previous studies carried out with low-dose isotretinoin
*

Safety and Efficacy of Low-Dose Isotretinoin in The Treatment of Moderate To Severe Acne Vulgaris

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Safety and Efficacy of Low-Dose Isotretinoin in The Treatment of Moderate To Severe Acne Vulgaris

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In this prospective, non-comparative study, 50 participants, both male

effects, in a more cost effective manner.

0 completely cleared 100% lesion clearance

Age above 12 years and of both the sexes

Age less than 12 years

Out of the total number of 50 participants, 38 participants (76%) were

participants (4%); 1 participant falling in the range of grade I to

isotretinoin combined with tretinoin is effective to correct

Global acne grading system

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