Adv. Pharmacol. Toxicol.

13 (2) 2012, 65-70

ISSN - 0973 - 2381
EFFECT OF RIFAMPICIN AND CLOFAZIMINE OINTMENT
IN TREATING SKIN ULCERS, FOOTCRACKS AND
DISABILITY GRADING OF LEPROSY PATIENTS.
M. C. Prabhakar1*, D. Santhikrupa2, N. Manasa3 and O. Umamaheswara Rao1
1. Shri Vishnu College of pharmacy, BHIMAVARAM, A.P
2. Sri Sai Aditya College of Pharmaceutical Sciences and Research, Surampalem,
KAKINADA, A.P
3. Anurag College of Pharmacy, Ananthagiri, NALGONDA, A.P
Leprosy mainly affects mucosa of the upper respiratory tract, the eyes,
the skin and also the peripheral nerves. Skin act as one of the reservoir for
M.leprae and Skin ulceration is the commonest serious problem in leprosy
patients. Though the patients can be cured of infection by multidrug therapy,
the immunopathological sequelae responsible for the characteristic deformities
of leprosy can continue during and even after antimicrobial therapy. In our
present study apart from the use of MDT, the leprosy patients were asked to
apply rifampicin and clofazimine ointment on ulcer affected area for four
weeks continously and the prominent cure of skin ulcer was observed after the
treatment. The use of RCO had also treated the foot cracks in some patients.
Based on the prevention of disability profile (POD) of the patients in our study
(n=130) we had observed 98% of the patients having any one of disabilities
regarding hand, foot, eye and nerve. 4% of the people had got one of their legs
amputated and 90% of the observed people are having nerve involvement and
thought of having neuritis. 3% of the male patients are observed with
gynacomastia. 4% of the patients are found to have foot drop. 15% of the
patients have eye involvement; most of them are having unilateral or bilateral
lagophthalmos. This assessment of grading will give a better picture to realize
the importance of POD activities, early diagnosis of the disease and prevention
of secondary disabilities.
INTRODUCTION
Leprosy is a chronic infectious disease caused by Mycobacterium leprae, an acidfast, rod-shaped bacilli. It has long latent, induction period, usually three to six years in the
tuberculoid form of disease and three to ten years in the multi bacillary form. Its transmission
rate greatly exceeds the clinical attack rate (Goulart and Goulart, 2009) .Skin forms one of
the largest tissues where the M. lepraeare concealed (Drutz, 1974; Prabhakar et al., 1994).
* Corresponding Author

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Unlike many other infectious diseases, in MB patients the M. leprae are found at many sites
to which the blood circulation could be either poor (skin)(Prabhakar et al., 1983). Skin
ulceration is the commonest serious disability in leprosy and they occur in about 1020% of
leprosy patients. The moment an ulceration occurs, this foot or hand becomes 'ulcer-prone'
and a vicious cycle of scar-ulcer-scar sets in (Nienhuis et al., 2004). Anaesthesia,
unprotective walking, poor quality of scar resulting from previous ulceration, excessive load
on this scar and persisting foci of infection are some of the main reasons for recurrence of
ulcers. In spite of recent advances and emergence of new drug therapy for combating leprosy
per se, treatment of these ulcers has taken a backseat (Ramu, 1981). Leprosy is a leading
cause of permanent physical disability. A cumulative total of the number of individuals who,
over the millennia, have suffered its chronic course of incurable disfigurement and physical
disabilities can never be calculated (Sundar Rao, 2006).Timely diagnosis and treatment of
cases, before nerve damage has occurred, is the most effective way of preventing disability
due to leprosy (Anton , 1994). Only some of those affected go on to experience active forms
of disease leading to nerve impairment with the possibility of M. leprae invasion of Schwann
cells of the peripheral nervous system (Richards, Finlay., 1996). Based on WHO Disability
Grading and Prevention of disability activities grades are attributed to each eye, hand and
foot, where the highest value attributed to these points represents the maximum disability
grade of the individual and is used as an indicator of the severity of impairment (WHO
Expert Committee on Leprosy, 1988).
MATERIAL AND METHODS
Method of preparation of Rifampicin and ClofazimineOintment (Venkateswarulu et al.,
1984):
Paraffin ointment base B.P.
Hard paraffin
3g
White bees wax
2g
Cetosteryl alcohol
5g
White soft paraffin
90g
Rifampicin and Clofazimine 1g each.
The first four ingredients were melted together by heating on a water bath. The
molten base was slowly triturated with Rifampicin and Clofazimine in a clean dry mortar.
The ointment was allowed to cool to room temperature and filled into collapsible tubes and
labelled. The patients having skin ulcers and foot cracks were asked to apply this ointment
on the ulcer effected area or cracks for four weeks continuously. The research work protocols
were approved by the Institutional ethical committee prior to the beginning of study.
Disability grading of the leprosy patients living in and around bhimavaram.
The number of patients involved in this study are n=100 from the leprosy colony and
leprosy centre, Bhimavaram (Andhrapradesh). Based on POD activity profile the percentage
disabilityof the patients involved in the study are determined.

Effect of Rifampicin and Clofazimine Ointment

67

RESULTS
Effectiveness of Rifampicin and Clofazimine Ointment Fortopical Ulcers:

Before treatment with RCO

After treatment with RCO

Before treatment with RCO

After treatment with RCO

DISABILITY GRADING OF THE LEPROSY PATIENTS

In our present study among the 130 patients, we had observed 98% of the patients
having any one of disabilities regarding hand, foot, eye and nerve. About 4% of the people
had got one of their legs amputated and 90% of the observed people are having nerve
involvement and thought of having neuritis. 3% of the male patients are observed with
gynacomastia. 2% of the patients are found to have filariasis. 4% of the patients are found to
have foot drop. 15% of the patients have eye involvement; most of them are having unilateral
or bilateral lagophthalmos. We had treated few patients to takeTearsol eye drops to reduce the
dryness of the eyes.

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DISCUSSION
Effect of Rifampicin and Clofazimine Ointment in the treatment of topical ulcers
The PB and MB type of leprosy is distinguished from other types by the presence of
patches in tuberculoid and presence of ulcers in MB patients. The patients were more worried
about these ulcers, than disease itself (Weir et al., 1994).For such a localized lesion topical
treatment would serve better than systemic treatment (Prabhakar,1989). In our study we had
found about 80% of the patients weresuffering with the topical or plantar ulcers. We treated
the patients with rifampicin and clofazimine ointment in combination for about few weeks
and observed distinguishable result after the treatment. Rifampicin and Clofazimine
ointment was found to be effective in treating the topical ulcers. In these patients M. leprae
are localized in the ulcers and patches. The blood flow to the skin is low; hence oral therapy
may not result in the availability of adequate amounts of drug at the effected site. To obtain
the high concentrations of the drug at the patch or topical ulcer, an ointment is more suitable
because large amounts of the drug can be made available at the local site and these high local
concentrations of drug can attack M. leprae more effectively. This study clearly indicates
that the infection is prevailing inspite of MDT for such a long period. As leprosy is
multifaceted disease the therapy should be aimed at different sites in order to get rid off this
dreaded disease.
Disability grading of the Leprosy patients living in and around Bhimavaram.
The prevention of primary impairment is important to prevent the disability, but
steroids are of limited efficacy and only three good trials have been done on the effectiveness
of steroids in treating nerve damage. Hugh Cross highlights that the paradox of leprosy
programs apparently practicing a very high level of prevention of disability (POD) activities
but seemingly having very little to show for all these activities and no evidence on how
sustainable this is (Reddy, 1987). The prevention of peripheral nerve dysfunction is
primarily dependent on early detection (Cornbrooks,1983).The prevention of secondary and
tertiary disability is now reconsider as a significant concern by the WHO, which in ratifying
it revised strategy in 2006, finally bought the issue of disability prevention and management
squarely in to the domain of leprosy control. Richard (1996) had stressed that progress of
disease at an early stage will significantly reduce the risk of impairment, MDT perse appears
to have very limited efficacy. Prevention of primary impairments includes reduction of
reactions in neuritis.In our present study among the 130 patients we had observed 98% of the
patients having any one of disabilities regarding hand, foot, eye and nerve. About 4% of the
people had got one of their legs amputated and 90% of the observed people are having nerve
involvement and thought of having neuritis. 15% of the patients have eye involvement; most
of them are having unilateral or bilateral lagophthalmos. We had treated few patients to take
Tearsol eye drops to reduce the dryness of the eyes. 3% of the male patients are observed with
gynacomastia. 2% of the patients are found to have filariasis. 4% of the patients are found to
have foot drop.Though they had treated with MDT their disabilities remain helpless. We had
helped them to prevent the further damage which may occur due to increase in number of M.
leprae in the nose and eye with our rational therapy

Effect of Rifampicin and Clofazimine Ointment

69

CONCLUSION
Rifampicin-clofazimine ointment gave a better distinguishable result, within 4 or 5
weeks regular application of ointment on the topical ulcers. RCO has also decreased the
cracks on legs within 4 days of continuous application. In combination (rifampin and
clofazimine), erythema, inflammation, and oedema are considerably reduced
(Venkateswarlu, 1988). It is suggested that topical therapy with rifampin and
clofazimineointments would be economical and beneficial in tuberculoid leprosy, and
external massage with neem oil for neuritis pian, use of turmeric with lemon juice for patches
gave better results and to the fullest satisfaction of the patients.It was concluded from the
disability grading of leprosy patients that most of the patients are suffering with disabilities,
even though they are treated with MDT for longer periods. This assessment of grading will
give a better picture to realize the importance of POD activities and early diagnosis of the
disease.
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