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| ORIGINAL ARTICLES |
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| Year : 2023 | Volume
: 11
| Issue : 1 | Page : 14-20 |
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Evaluation of efficacy and safety of Amarantha footcare cream in subjects suffering from cracked heels (xerosis of the feet): A randomized, open labeled, multi-centric, comparative, interventional, prospective, clinical study
Sanjay U Nipanikar1, Narendra B Mundhe2, Kamlakar V Gajare3, Pranita Joshi Deshmukh4
1 Ari Healthcare Pvt. Ltd., Pune, India
2 Department of Kayachikitsa, KVTR Ayurvedic College, Dhule, India
3 Department of Surgery, MAM’s SS Ayurveda Mahavidyalaya, Pune, India
4 Sane Guruji Aarogya Kendra, Pune, Maharashtra, India
| Date of Submission | 23-Nov-2022 |
| Date of Decision | 16-Feb-2023 |
| Date of Acceptance | 23-Feb-2023 |
| Date of Web Publication | 15-Apr-2023 |
Correspondence Address:
Sanjay U Nipanikar
Ari Healthcare Pvt. Ltd., No. 107, 1st Floor, S.No. 1, World Trade Center, Tower One, Opp. EON SEZ, Kharadi, Pune 411014, Maharashtra
India
 Source of Support: None, Conflict of Interest: None
DOI: 10.4103/jism.jism_96_22
Xerosis of the foot can lead to cracks in plantar surface with discomfort, pain, and predisposition to infection. This study was conducted to evaluate the comparative efficacy and safety of Amarantha footcare cream (AFC) in subjects suffering from cracked heels (xerosis of feet). A total of 79 subjects (26 in AFC group, 26 in marketed cracked heal cream [MCHC] group, and 27 in Amarantha wound healing cream [AWHC] group) were completed the study. All trial subjects were advised to apply sufficient quantity of given creams, twice daily for 28 days or till complete clearance of the cracked heel, whichever was earlier. Study subjects were called for follow-up visits on days 7, 14, 21, and 28. Clinical trial registry of India registration number is CTRI/2020/11/028829. The mean days required for complete healing of cracked heel were 16.69, 22.96, and 25.74 in AFC, MCHC, and AWHC groups respectively. The mean xerosis score was significantly reduced (P < 0.01) in AFC group than other groups from baseline to end of study. Overall clinical cutaneous score was significantly (p < 0.01) reduced in AFC group as compared to other two groups on day 7, 14 and 21. AFC group showed overall very much improvement than other two groups at the end of the study. Few adverse events were reported; however, none was related to study drugs. AFC is safe and effective for the treatment of cracked heels (planter xerosis). Keywords: Amarantha footcare cream, AWHC (Amarantha wound healing cream), hyperkeratosis, MCHC (marketed cracked heal cream), planter xerosis, xerosis assessment scale
How to cite this article:
Nipanikar SU, Mundhe NB, Gajare KV, Joshi Deshmukh P. Evaluation of efficacy and safety of Amarantha footcare cream in subjects suffering from cracked heels (xerosis of the feet): A randomized, open labeled, multi-centric, comparative, interventional, prospective, clinical study. J Indian Sys Medicine 2023;11:14-20 |
How to cite this URL:
Nipanikar SU, Mundhe NB, Gajare KV, Joshi Deshmukh P. Evaluation of efficacy and safety of Amarantha footcare cream in subjects suffering from cracked heels (xerosis of the feet): A randomized, open labeled, multi-centric, comparative, interventional, prospective, clinical study. J Indian Sys Medicine [serial online] 2023 [cited 2023 Jun 7];11:14-20. Available from: https://www.joinsysmed.com/text.asp?2023/11/1/14/374261 |
| Introduction | |  |
The skin is the largest organ of the body which plays an important role in protecting the body against pathogens.[1] Skin varies in its morphology and function depending upon its location. Although the skin on the plantar surface of the foot is very thick, it is highly viscoelastic in nature. It is able to cope with the high levels of frictional, compressive, and shear stress applied to it during weight bearing.[2]
Normal skin is soft with a pliable texture to its water content. The outer layer of skin contains oil, which slows evaporation and holds moisture in the deeper layers of skin which helps to decrease water loss. If the oil is depleted, the skin becomes dry. Xerosis is a medical term used to describe dryness in the epidermal layers of skin.[3],[4] Xerosis is caused due to a lack of moisture in the skin. Because of this, skin becomes very dry, rough, scaly, and itchy.[3]
Xerosis of the foot is a common condition, which can lead to discomfort, pain, and predisposition to infection. Hence, there is an increased risk of cellulitis and foot ulceration.[4] Risk factors for xerosis include friction, prolonged standing, obesity, diabetes, hypothyroidism, sunlight, low humidity, excess use of soaps, and lack of minerals and vitamins such as iron. Xerosis also presents as a symptom of cutaneous conditions such as psoriasis, dermatitis, and ichthyosis.[5],[6] The most common symptoms of dry, cracked heels and feet include red flaky patches, peeling and cracked skin, and itchy skin with bleeding or discharge from cracks. When the fissures or cracks are deep, they are very painful to stand on.[7] Treatment of xerosis is rehydrating the stratum corneum. Emollients containing urea or alpha-hydroxy acids are particularly effective in reducing dryness. Moisturizing ointments or creams containing petroleum jelly, mineral oil, or glycerin can also be used for xerosis.[8],[9]
According to Ayurveda, dry skin is caused by Vata Dosha. When Vata Dosha increases in the body, it makes the skin very dry and wrinkled. The aggravated Vata gives rise to peculiar painful cracks (Dari in the affected parts) which are called Padadari. When the feet become too dry, heel fissures can develop quite easily. In ancient Ayurvedic texts, many herbs are described with excellent Vranaropak (wound healing activity). Jatyadi Taila, Ral (Shuddha), Tila Taila, and Goghrit may help to keep the skin hydrated, soft which helps in proper healing of cracks and reducing symptoms.[9],[10],[11]
Ari Healthcare Pvt. Ltd. has conceptualized and developed AHPL/AYTOP/0817 in cream dosage form to be used for the treatment of cracked heels (xerosis of the feet). AHPL/AYTOP/0817 is marketed in India under the brand name of Amarantha Footcare cream (AFC). AFC contains Madhuka Taila, Jatyadi Taila, Sarjaras Exudate, Tankan Bhasma, and Pudina Satva. Ingredients of AFC moisturize and nourish dry skin of cracked heels. Ingredients possess anti-microbial, anti-inflammatory, and analgesic properties. Also, ingredients help to heal the fissures of the feet. Thus, by virtue of synergistic action of the ingredients, AFC heals a cracked heel.[12],[13],[14],[15],[16],[17]
Looking at the activities of ingredients of formulation, a hypothesis was postulated that AFC would be helpful in the management of cracked heels. The present clinical study was planned to test this hypothesis.
| Materials and Methods | | |
Study Site
The study was conducted at two trial sites viz. MAM’s SS Ayurveda Mahavidyalaya and Sane Guruji Aarogya Kendra, Malwadi, Hadapsar, Pune, Maharashtra, India and at KVTR Ayurved College and Hospital, Boradi, Dhule, Maharashtra, India.
Ethical Consideration and Approval
The study protocol and related documents were reviewed and approved by the institutional ethics committee (IEC) of MAM’s SS Ayurveda Mahavidyalaya and Sane Guruji Aarogya Kendra, Malwadi, Hadapsar, Pune and IEC of KVTR Ayurved College and Hospital, Boradi, Dhule. The study was conducted in accordance with good clinical practices guidelines (issued by AYUSH in 2013). The present clinical study is registered on clinical trial registry of India. The Clinical trial registry of India registration number is CTRI/2020/11/028829 [registered on: 03/11/2020]. The study was initiated after IEC approvals and Clinical trial registry of India registration.
Study Design
An open labeled, prospective, randomized, comparative and multi centre clinical study.
Study Objectives
The primary objective of this study was to evaluate the efficacy of AFC in comparison to Amarantha wound healing cream (AWHC) and competitor’s product, that is, marketed cracked heal cream (MCHC) in subjects suffering from cracked heels (xerosis of the feet) by assessing the number of days required for complete healing/complete clearance of index cracked heel. The secondary objectives were to evaluate the efficacy and safety of AFC compared to AWHC and MCHC by assessing changes in the xerosis assessment scale, changes in skin roughness using a graded scale, changes in hyperkeratosis using a graded scale, changes in overall clinical cutaneous score (OCCS), drug compliance at every follow-up visit, global assessment of overall change by investigator and subject at the end of the study, and changes in the tolerability of trial drugs by patient and by physician at the end of the study by assessing adverse events/adverse drug reactions.
Sample Size
The sample size was calculated as per the following method
α = significance level
β = power of test (80.0%)
x1 = average days required for healing in the ref. group = 24.0 days
x2 = average days required for healing in the test group = 16.0 days
SD = standard deviation = 10.0
d = actual difference (x2 – x1) = 8 days
Based on the above assumptions, a total sample size of 69 completed cases and 23 cases in each group were needed to assess the study objective at 80% power. Considering 20% dropout, a total of 95 cases (32, 31, and 32 cases in AFC, MCHC, and AWHC groups, respectively) were enrolled in this study with the allocation of 1:1:1 case in each arm.
Subject Selection
Male and female subjects between 21 and 65 years of age (both inclusive) suffering from moderate to severe xerosis of foot [xerosis assessment scale (XAS) score > 3 and <7], attending outpatient department at respective study sites, willing to follow study procedures mentioned in protocol, and who voluntarily signed the informed consent forms were screened for the study. Subjects, who had not used any moisturizers or keratolytic agents since the last week of screening visit, were included in study. Subjects having foot lesions (ulcer, skin infection); very severe hyperkeratosis requiring chiropody treatment; and skin disorders affecting the foot such as infections (e.g., Athlete’s foot), dermatitis, psoriasis, un-healed skin wounds (including open heel fissures), ulcers or blisters were excluded from the study. Subjects with systematic disease including peripheral vascular disease or musculoskeletal disorders of the foot or ankle, or subjects with major debilitating diseases or disorders (as per investigator’s opinion), which can interfere with skin health were excluded from the study. Subjects with known hypersensitivity to trial medicines or their components; pregnant and lactating
women were excluded from the study.
Investigational Drug
The investigational products including AFC and AWHC were manufactured by the sponsor, that is, Ari Healthcare Pvt. Ltd., following GMP and all applicable regulatory guidelines. The composition of the drug is given in [Table 1] and [Table 2], respectively. The comparative product MCHC was procured from the market. As per randomization list, subjects were allocated to one of the three study groups in 1:1:1 ratio. Subjects were asked to wash their feet with lukewarm water, dry the feet, and apply a sufficient quantity of given cream twice daily for 28 days or complete healing/complete clearance of the index cracked heel, whichever was earlier.
Number of Visits
After screening visit/baseline visit (day 0), all the subjects were called at the study site for follow-up visits in following manner viz. visit 1 (day 7), visit 2 (day 14), visit 3 (day 21), and visit 4 (day 28). If the cracked heel was resolved earlier than this (as per the investigator’s opinion) subject was declared as completed and had to make no more follow-up visits.
Study Procedure
On screening visit/baseline visit (day 0), subjects suffering from moderate-to-severe xerosis were screened for the study. A written informed consent was obtained from the subjects for their participation in the study. Subjects’ demographic data and medical history were recorded. Subjects’ physical and systemic examinations were performed. Subjects were recruited in the study, if they met the eligibility criteria. Subjects’ xerosis was assessed on XAS. Subjects’ skin roughness and hyperkeratosis were evaluated on a graded scale. OCCS was calculated. OCCS is the sum of xerosis assessment scale, skin roughness, and hyperkeratosis.
On the baseline visit, all the subjects were randomized to one of the three study groups. On baseline visit and every follow-up visit, subjects were given one tube of the assigned product for use for the next 7 days. Subjects were advised to apply given study products on both the feet; however, only one foot (index foot) was evaluated for efficacy and safety assessment. Subjects were asked to wash their feet with lukewarm water, dry the feet, and apply a sufficient quantity of given cream twice daily for 28 days or complete healing/complete clearance of the index cracked heel, whichever was earlier.
On every visit, used medication tubes were collected from the subject and the remaining medicines were weighed to check the missed dosage. If 80% study medication was used over 80% time, the subject was considered compliant. If <80% of study medication used over 80% of time, the subject was considered as non-compliant. If the subject was non-compliant, she/he was withdrawn from the study. Subjects were allowed to come for follow-up either 2 days prior or after the scheduled follow-up visit.
On every visit, all the subjects were closely monitored for any adverse event, and a proper record of adverse event, serious adverse event, and adverse drug reaction (if any) was maintained. The subjects were advised to continue the diet and exercise regimen (which they were already following) during the entire study period. On every visit, the subjects’ general and systemic examinations were performed. The subjects were assessed on XAS scale, skin roughness, hyperkeratosis grades, and OCC score. All the clinical parameters were recorded by the same investigator throughout the study.
Global assessment of the overall change and tolerability of trial drugs (assessed by subject and by investigator) were performed at the end of the study.
Statistics
A consultant statistician performed the analysis of the data using the statistical software Statistical Package for Social Sciences (SPSS) 10.0 for Windows. Data describing quantitative measures were expressed as median or mean ± SD or SE or the mean with range. Qualitative variables were presented as count and percentages. The primary efficacy variable, that is, the number of days required to heal the cracked heel was analyzed by using ANOVA. If mean changes were significant, a post hoc test was applied to assess the significant difference between the groups by the Bonferroni test. For secondary efficacy variables such as, changes in XAS score, skin roughness score, hyperkeratosis score, OCCS, and assessment of improvement were analyzed between and within groups using the Chi square test. All P-values were reported based on two-sided significance test, and all the statistical tests were interpreted at 5% level of significance.
| Results | | |
A total of 95 subjects (32 in AFC group, 31 in MCHC group and 32 in AWHC group) were recruited in the study. There were no screen failures. Out of the 95 recruited subjects, 79 subjects completed the study. There were 16 dropouts in the study. In the AFC group, six subjects were dropped out due to drug noncompliance. In the MCHC group, five subjects (three subjects due to drug noncompliance and two subjects due to lost to follow-ups) were dropped out. In the AWHC group, five subjects (four subjects due to drug noncompliance and one subject due to lost to follow-up) were dropped out. No statistically significant difference (P > 0.05) was observed between groups with respect to sex-wise distribution and average age of the subjects. The demographic details of the subjects are presented in [Table 3].
The mean days required for complete healing of the index cracked heel were 16.69 ± 5.74, 22.96 ± 5.76, and 25.74 ± 3.37 in the subjects from AFC, MCHC, and AWHC groups, respectively. When a comparison was made between the groups, AFC group took significantly (P < 0.01) less number of days than other groups for healing of cracked heels. The details are presented in [Table 4] and [Figure 1]. Also, it was observed that all the subjects of the AFC group were reported significant (P = 0.001), complete healing of the cracked heel within 28 days of the study treatment as compared to MCHC and AWHC groups. | Table 4: Comparison of the mean duration of days required for healing of the index cracked heel between the groups
Click here to view |
 | Figure 1: Comparison of the mean duration of days required for healing of the index cracked heel between the groups
Click here to view |
The mean score of xerosis was reduced significantly (P < 0.01) from 5.46 ± 0.81 at baseline to 3.23 ± 1.70, 1.50 ± 1.75, 0.23 ± 0.59, and 0.04 ± 0.20 on days 7, 14, 21, and 28, respectively, in AFC group; from 5.69 ± 0.55 at baseline to 4.58 ± 1.10, 3.35 ± 1.92, 2.23 ± 2.08, and 1.73 ± 2.11 on days 7, 14, 21, and 28, respectively, in MCHC group; and from 5.48 ± 0.85 at baseline to 4.93 ± 0.96, 34.04 ± 1.32, 2.96 ± 2.01, and 2.30 ± 2.22 on days 7, 14, 21, and 28, respectively, in AWHC group. When compared between the groups, a statistically significant (P < 0.01) reduction in the mean score of xerosis was observed on all the follow-up visits in AFC group than other two groups. There was no statistically significant difference between MCHC and AWHC groups on all visits.
According to the xerosis assessment scale, not a single case had normal skin among all the groups at the baseline visit; and no single case from MCHC group and AWHC group had a normal skin on days 7 and 14. The difference between the groups was insignificant (P > 0.05). On days 7 and 14, 7.7% and 42.3% (P < 0.01) of cases from AFC group had a normal skin, respectively. On day 21, 84.6% of cases from AFC group, 30.8% from MCHC group, and 7.4% of the cases from AWHC group had a normal skin, which was significantly (P < 0.01) more compared to baseline except in AWHC group. On day 28, 96.2% of cases from AFC group, 50.0% from MCHC group, and from 37.0% AWHC had normal skin, which was significantly (P < 0.01) more compared to baseline. If compared between the groups, AFC group was having significantly (P < 0.05) a greater number of cases of normal skin compared to other two groups on days 14, 21, and 28.
The mean skin roughness score was reduced significantly (P < 0.01) from 1.50 ± 0.76 at baseline visit to 0.77 ± 0.65, 0.15 ± 0.46, 0.08 ± 0.27, and 0.00 on days 7, 14, 21, and 28, respectively in AFC group; from 1.54 ± 0.76 at baseline visit to 1.08 ± 0.74, 0.81 ± 0.85, 0.35 ± 0.63, and 0.23 ± 0.43 on days 7, 14, 21, and 28, respectively, in MCHC group; and from 1.63 ± 0.63 at baseline visit to 1.30 ± 0.78, 1.07 ± 0.78, 0.63 ± 0.74, and 0.41 ± 0.64 on days 7, 14, 21, and 28, respectively, in AWHC group. When compared between the groups, no significant difference (P > 0.05) was observed between AFC and MCHC groups on day 7. However, AFC group has shown significantly more reduction in skin roughness score than AWHC group on day 7. If compared between the groups, statistically significant (P < 0.05) more reduction in mean score of skin roughness was observed on day 14 in AFC group than other two groups. There was no significant difference (P > 0.05) between any groups on days 21 and 28. There was no statistically significant difference (P > 0.05) between MCHC group and AWHC group on all visits.
The changes in the proportion of cases with skin roughness were assessed on supple skin, stiff skin, and rough skin parameters. The percentage of cases who had supple skin was improved from 15.4% cases at baseline to 34.6%, 88.5%, 92.3%, and 100.0% on days 7, 14, 21, and 28 respectively in AFC group; from 15.4% cases at baseline to 23.1%, 46.2%, 73.1%, and 76.9% on days 7, 14, 21, and 28, respectively, in MCHC group; and from 7.4% cases at baseline to 18.5%, 25.9%, 51.9%, and 66.7% on days 7, 14, 21, and 28, respectively, in AWHC group. If compared, there was no significant difference (P > 0.05) between any groups on day 7. However, the change was significantly (P < 0.05) more among AFC group than other two groups on days 14 and 28. On day 21, the change was significantly (P < 0.05) more among AFC group than AWHC group. The change was more among AFC group than MCHC group, but the difference was insignificant (P > 0.05).
The mean hyperkeratosis score was reduced from 0.04 ± 0.20 at baseline visit to 0.00 ± 0.00 on day 7 and remained 0.00 on days 14, 21, and 28, respectively, in AFC group; from 0.08 ± 0.27 at baseline visit to 0.08 ± 0.27 each on days 7, 14, and 21, respectively, and 0.04 ± 0.20 on day 28 in MCHC group; and from 0.07 ± 0.27 at baseline visit to 0.04 ± 0.19 on day 7 and 0.00 ± 0.00 on days 14, 21, and 28, respectively, in AWHC group. When compared between the groups, no statistically significant difference (P > 0.05) was observed on all follow-up visits.
The changes in proportion of cases with hyperkeratosis were assessed on no hyperkeratosis, hyperkeratosis (but not severe), and severe hyperkeratosis parameters. The percentage of cases who had no hyperkeratosis was improved from 96.2% cases at baseline to 100.0% cases on day 7 in AFC group; from 92.3% cases at baseline to 92.3% cases on day 7 in MCHC group; and from 92.6% cases at baseline to 96.3% cases on day 7 in AWHC group. If compared, the difference between the groups was statistically insignificant (P > 0.05). The same trend was observed on days 14, 21, and 28.
The mean OCCS was reduced significantly (P < 0.01) from 7.00 ± 0.94 at baseline visit to 4.00 ± 2.00, 1.73 ± 2.09, 0.31 ± 0.84, and 0.04 ± 0.20 on days 7, 14, 21, and 28, respectively, in AFC group; from 7.31 ± 0.88 at baseline visit to 5.73 ± 1.25, 4.23 ± 2.47, 2.65 ± 2.45, and 2.00 ± 2.45 on days 7, 14, 21, and 28, respectively, in MCHC group; and from 7.19 ± 0.96 at baseline visit to 6.22 ± 1.19, 5.11 ± 1.28, 3.59 ± 2.37, and 2.70 ± 2.60 on days 7, 14, 21, and 28, respectively, in AWHC group. When compared between the groups, the change was significantly (P < 0.05) more in AFC group as compared to other two groups on days 7, 14, and 21. On day 28, the change was nonsignificantly more in AFC group as compared to MCHC group and significantly more than AWHC group. If compared, the change was more in MCHC group than AWHC group, but difference was insignificant (P > 0.05).
All (100%) the cases showed drug compliance to trial medicines in all visits except at day 7 visit, 96.3% cases in AWHC group showed drug compliance. If compared, the difference between groups was insignificant (P > 0.05).
As per the global assessment for the overall change done by the physician at the end of the study, among AFC group 96.2% cases had very much improvement, and 3.8% cases had much improvement, whereas among MCHC group, 42.3% cases had very much improvement, 23.1% cases had much improvement, 30.8% cases had minimal improvement, and 03.8% cases had no change in the cracked heel. Also, among AWHC group, in total, 25.9% cases had very much improvement, 22.2% cases had much improvement, 37.0% cases had minimal improvement, and 14.8% cases had no change in the cracked heel. As per the global assessment for the overall change done by the subject at the end of the study, among AFC group 96.2% cases had very much improvement, and 3.8% cases had much improvement, whereas among MCHC group, 42.3% cases had very much improvement, 26.9% cases had much improvement, 23.1% cases had minimal improvement, and 7.7% cases had no change in the cracked heel. Also, among AWHC group, in total, 25.9% cases had very much improvement, 22.2% cases had much improvement, 40.7% cases had minimal improvement, and 11.1% cases had no change in cracked heel. When compared among the groups, AFC group showed statistically significant (P < 0.05) overall change assessed by the physician and by subject in cracked heel condition than other two groups.
As per global assessment of the overall tolerability of study drugs assessed by physician and subjects at the end of the study, it was observed that 84.6% cases reported excellent tolerability, and 15.4% subjects reported good tolerability to AFC group. In total, 73.1% cases were reported to have excellent tolerability and 26.9% cases were reported to have good tolerability to MCHC. In total, 81.5% cases were reported excellent tolerability and 18.5% cases were reported good tolerability to AWHC.
A total of four subjects in AFC group were reported adverse events including disturbed sleep, burning micturition, cold, and knee joint pain; seven subjects in MCHC group reported adverse events including headache, burning,mouth ulcer, vomiting, and fever, and four subjects in AWHC group were reported adverse events including the color of cream was not easily washable, foreign body in left eye with pain, and loose motion. All of these adverse events were mild in nature, subsided with treatment, and did not require to stop the study drug application. As per the investigator, adverse events were unrelated to any of the study drugs. No serious adverse event was recorded during the whole study period.
Also, no statistically significant (P > 0.05) change from baseline to end of therapy values in any of the vital signs (pulse rate, body temperature, respiratory rate, and systolic and diastolic blood pressure) was observed in all the groups.
| Discussion | | |
In the present clinical study, AFC was compared with AWHC and competitor’s marketed product in cracked heels (xerosis of feet). In the present clinical study, it has been observed that subjects from AFC group required mean 16.69 days for healing of index cracked heel which was significantly less as compared to mean 22.96 and 25.74 days required for healing of index cracked heel of MCHC and AWHC groups, respectively [Figure 1]. This indicates that drug AFC scored over the other two comparator creams in the management of cracked heel (xerosis of feet).
Statistically significant (P < 0.01) more reduction in mean score of xerosis was observed on all follow-up visits in AFC group than MCHC and AWHC groups. There was statistically significant (P < 0.01) reduction in skin roughness, and OCCS in the subjects of AFC group than MCHC and AWHC groups. On day 28, 96.2% of cases from AFC group, 50.0% from MCHC group and from 37.0% AWHC had a normal skin, which was significantly more compared to baseline. If compared, AFC group was having significantly (P < 0.01) more number of cases of normal skin as compared to competitor’s product group and AWHC group. Early healing of cracked heels, reduction in hyperkeratosis, and roughness of skin may be contributed to have normal skin in the subjects of AFC group as compared to competitor’s and AWHC groups.
As per the global assessment for overall change assessed by physician and subjects at the end of the study, all the subjects of AFC group showed much to very much improvement, whereas almost half of the subjects of MCHC group and AWHC group reported minimal improvement or no change in the condition suggesting significant superiority in terms of efficacy of AFC over competitor’s product and AWHC.
Deficiency in moisture-binding substances collectively known as the natural moisturizing factor, deficiencies in the skin barrier lipids, ceramides, and a deficiency of the skin’s own moisture network in the viable epidermis are a few of the factors that lead to xerosis of feet.[1],[2],[3],[4],[5],[6],[7],[8] Majority of the ingredients of AFC possess hydrating and/or moisture barrier properties. Oil extracted from seeds of Madhuca indica possesses skin moisturizing, anti-inflammatory, anti-microbial, and wound healing properties.[12]Sarjaras possesses emollient, wound healing, and analgesic properties. It protects skin from atmospheric aggressions.[13]Jatyadi Taila has been used for the effective management of wound and ulcers. It keeps skin moisturizing and also free from microbes and thus helps in healing of cracked heels.[14]Tankan Bhasma is used in the process of repair that follows injury to the skin and other soft tissues. It heals wound in the shortest time possible, with minimal pain, discomfort, and scarring to the patient.[15]Pudina Satva provides cold sensations as well as an analgesic effect at cracked feet. It helps in wound healing by increasing blood flow at application site.[16] Thus, synergistic action of ingredients of AFC may have resulted in early and better healing of cracked heels.[17]
There were four (15.4%) adverse events in AFC group, seven (26.9%) in competitor’s product group, and four (14.8%) in AWHC group reported during the study period. All these adverse events were mild in nature and subsided with treatment and did not require stopping the study drug application. As per investigator, these adverse events were unrelated to the study drugs. It was observed that pulse rate, systolic and diastolic blood pressure, and respiratory rate were within normal limits at baseline visit and at every follow-up visit till the end of the study in all the groups. Majority of the subjects of all the groups reported excellent tolerability to study drugs suggesting excellent safety of all the three study drugs.
| Conclusion | | |
It can be concluded from the results of the study that AFC is safe to use in subjects suffering from cracked heels. AFC is significantly better effective in early healing of cracked heels, alleviating skin roughness, hyperkeratosis of skin, and making skin soft than marketed competitor’s product and AWHC. Thus, AFC is a safe and effective treatment option for cracked heels.
Financial Support and Sponsorship
This work was supported by Ari Healthcare Pvt. Ltd.
Conflicts of Interest
There are no conflicts of interest.
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[Figure 1]
[Table 1], [Table 2], [Table 3], [Table 4]
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