|Year : 2023 | Volume
| Issue : 1 | Page : 13-17
Positioning of low alcohol or alcohol-free minoxidil formulation for the management of androgenetic alopecia: Indian perspective
Satish Udare1, Anita Baruah2, Anurag Mathur3, TR Dayananda4, Kapil Jain5, Manas Ranjan Puhan6, Pawan Bajaj7, Richa Sharma8, Sanjay Ramanbhai Gamit9, V Ramesh10, V Venugopal11, Vignesh Karthik12, Monil Yogesh Neena Gala13, Snehal Muchhala13, Amey Mane13
1 Sparkle Skin and Aesthetic Centre, Navi Mumbai, Maharashtra, India
2 Department of Dermatology, New Era Hospital, Nagpur, Maharashtra, India
3 Department of Dermatology, IADVL, IMA, Meerut, Uttar Pradesh, India
4 Sarvad Skin and Laser Center, Mysore, India
5 Skin Prayag - The Skin and Hair Clinic, Delhi, India
6 Niki Skin Care, Bhubaneshwar, Odisha, India
7 Derma Clinic, Dibrugarh, Assam, India
8 Twacha Skin Clinic, New Delhi, India
9 Department of Dermatology, SRV Mamta Hospital, Dombivli, Maharashtra, India
10 Skin Laser Clinic, Hanamkonda, Telangana, India
11 Sankers Hospital, Kollam, Kerala, India
12 MGM Health Care, Chennai, Tamil Nadu, India
13 Dr. Reddy's Laboratories, Hyderabad, Telangana, India
|Date of Submission||17-May-2022|
|Date of Acceptance||31-Aug-2022|
|Date of Web Publication||19-Apr-2023|
Monil Yogesh Neena Gala
No. 8-2-337, Road No. 3, Banjara Hills, Hyderabad - 500 034, Telangana
Source of Support: None, Conflict of Interest: None
| Abstract|| |
Topical minoxidil is used for treating different hair disorders. Even though it is an effective therapy, many patients show poor compliance due to the cost, side effects, and duration of treatment. Topical minoxidil is the mainstay treatment for androgenetic alopecia (AGA). Recently, low alcohol or alcohol-free topical minoxidil formulation has proven to be an alternative for patients suffering from AGA, including those with poor compliance with other therapies. Thus, the current article provides the positioning of low alcohol or alcohol-free topical minoxidil to manage AGA in Indian clinical practice.
Keywords: Androgenetic alopecia, hair loss, male pattern hair loss, minoxidil
|How to cite this article:|
Udare S, Baruah A, Mathur A, Dayananda T R, Jain K, Puhan MR, Bajaj P, Sharma R, Gamit SR, Ramesh V, Venugopal V, Karthik V, Neena Gala MY, Muchhala S, Mane A. Positioning of low alcohol or alcohol-free minoxidil formulation for the management of androgenetic alopecia: Indian perspective. Int J Trichol 2023;15:13-7
|How to cite this URL:|
Udare S, Baruah A, Mathur A, Dayananda T R, Jain K, Puhan MR, Bajaj P, Sharma R, Gamit SR, Ramesh V, Venugopal V, Karthik V, Neena Gala MY, Muchhala S, Mane A. Positioning of low alcohol or alcohol-free minoxidil formulation for the management of androgenetic alopecia: Indian perspective. Int J Trichol [serial online] 2023 [cited 2023 May 28];15:13-7. Available from: https://www.ijtrichology.com/text.asp?2023/15/1/13/374397
| Introduction|| |
Androgenetic alopecia (AGA) affects almost 80% of men and 50% of women. A progressive reduction in the diameter and length of the hair causes AGA. Hair thinning results from the testosterone metabolite dihydrotestosterone (DHT) effects on androgen-sensitive hair follicles. AGA manifests as diffuse thinning of the crown region while maintaining the front hairline. Premenopausal women with AGA suffer from hyperandrogenism, hirsutism, and acne, while men with AGA have a bitemporal recession of the frontal hairline followed by diffuse thinning at the vertex.
White patients are commonly affected, followed by Asians and African Americans, then Native Americans and Eskimos. The Asian prevalence of AGA is lower than in Caucasians; AGA is also a common disorder in Asia. According to the epidemiologic data, about 58% of the male population in India develop AGA at some point in their lives, and this incidence increases with advancing age.
The incidence approaches the age in Caucasian males, with 50% affected by 50 years and up to 80% affected by 70 years. In females, the disorder is relatively common, with an increase in incidence after menopause. The psychological effect of hair loss is tremendous, potentially affecting a person's quality of life (QOL). There is a lack of awareness among people regarding the impact of hair loss on QOL. There is a moderate effect of visible hair loss on a person's emotions, social, symptomatic, and psychology. Medical practitioners can play a role in the improvement of patient's QOL by recognizing and addressing the psychological impact of alopecia.
In the balding scalp, the concentration of 5α-reductase is increased, resulting in more DHT production. Due to increased androgen receptor concentration, more complexes are produced between androgen receptors and DHT, augmenting the regulation of androgen-dependent genes in the nucleus.
Role of minoxidil in androgenetic alopecia
Topical minoxidil is a vasodilator, an anti-inflammatory agent, an inducer of the Went/b-catenin signaling pathway, and an antiandrogen. Minoxidil may also affect the length of the anagen and telogen phases. Thus, minoxidil may exert an effect through multiple pathways. Minoxidil stimulates the release of vascular endothelial growth factors (VEGF) in the dermal papilla cells and activates the VEGF-related b-catenin signaling pathway. β-catenin, accumulated in the cytoplasm by the Wingless–Int pathway, acts as a transcriptional factor and plays a role in hair follicle regeneration. Its antiandrogenic property reduces the 5a-reductase type 2 gene expression. Minoxidil also increases DNA synthesis in the anagen bulb, which triggers secondary germ cells of telogen follicles, resulting in the earlier onset of the anagen phase. It extends the anagen phase, reduces the telogen phase's duration, or does both. Minoxidil has also been investigated for the autoimmune condition alopecia areata. It is hypothesized that topical minoxidil inhibits immunological events at the application site and helps hair growth in patients diagnosed with alopecia areata. Topical Minoxidil is approved by Central Drugs Standard Control Organization (CDSCO) for the indication of Androgenetic alopecia and Female pattern hair loss [Table 1]. Guidelines recommendations and expert opinions for topical minoxidil are stated in [Table 2].
|Table 2: Recommendations for minoxidil based on International and National guidelines for managing androgenetic alopecia|
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The serum concentration is usually below 5 ng/mL, sometimes even undetectable. Three percent minoxidil solution could detect the serum minoxidil level concentration between 0.4 and 7.5 ng/mL. Two-time applications of 5% topical minoxidil to the entire scalp could be equivalent to the oral dose of 5.4 mg. Approximately 1.4% of topical minoxidil is absorbed through the scalp, while increased absorption is associated with drug concentration and frequency of drug application. Absorption of topical minoxidil systematically is <99% when applied on the scalp. Minoxidil does not bind to plasma proteins or cross the blood–brain barrier. About 95% of the systemically absorbed drug and its metabolites are excreted through the kidney within 4 days.,
Place of topical minoxidil in guidelines
Limitations of alcohol-containing minoxidil formulations
Alcohol-based topical solutions, including minoxidil, commonly cause dryness of the skin/scalp. Dryness of the scalp occurs due to loss of moisture from the stratum corneum, leading to low skin hydration. Propylene glycol-containing preparations are known to cause scalp sensitivity, itching, burning, and local irritation, and it has been evidenced in the literature that patients sensitive to propylene glycol are most likely susceptible to contact dermatitis.
Evidence suggests that patients treated with alcohol-based minoxidil topical solutions often report local irritation of the scalp, pruritus, itching, burning, dryness, and redness. These adverse events are more familiar with 5% minoxidil formulations than 2% minoxidil formulations, as a higher percentage of propylene glycol is used in 5% than 2% formulation to solubilize minoxidil. The local irritation caused by the alcohol-based topical solutions affects patients' self-tolerability and impacts patients' compatibility and adherence to the treatment in the long term. Evidence suggests that 11% of patients reported allergic contact dermatitis (11%) after using alcohol-based minoxidil solution. Patients suffering from allergic contact dermatitis may benefit from patch testing to prevent it.
Limitation of various hair transplant therapy with alcohol-based minoxidil formulation
Although a combination therapy of hair transplant therapy such as microneedling, mesotherapy, light therapy, and topical minoxidil is beneficial for treating alopecia, these procedures induce adverse effects such as pinpoint bleeding, seborrheic dermatitis, irritation, and itching., The application of alcohol-based minoxidil potentially may aggravate the procedure-related side effects. Thus, alcohol-free or low alcohol-based minoxidil formulations may be used in such cases.
Clinical benefits for less alcohol/alcohol-free minoxidil formulation
A double-blind, randomized controlled trial was conducted in androgenetic patients comparing 5% novel minoxidil topical solution and 5% minoxidil alcohol-based topical solutions for a month. After 30 days of therapy, the mean hydration significantly increased in patients treated with a 5% novel minoxidil formulation topical solution was 9.74 but was significantly reduced in patients treated with an alcohol-based solution (3.28) (P = 0.001). Novel minoxidil formulation was better tolerated compared with alcoholic formulations. In another double-blind, randomized controlled study, AGA patients received 5% minoxidil topical propylene glycol-free foam for 52 weeks. Statistically significant increase in hair counts in the 5% MTF group versus placebo (P < 0.0001) and subjective assessment of improved hair loss condition (P < 0.0001) in the 5% MTF group versus placebo [Table 3].
|Table 3: Clinical evidence of topical alcohol-free minoxidil in androgenetic alopecia|
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The need of this position paper is to provide dermatologists consensus on the use of less alcohol or alcohol-free topical minoxidil formulation for patients with AGA.
| Methodology|| |
The primary target audience for this position paper is dermatologists. The recommendations are also to be used by policymakers to develop protocols and policies and support staff education. Twelve dermatologists practicing in India were chosen for the expert panel to represent a comprehensive and holistic view of alcohol-free minoxidil formulation for the treatment of AGA. The main aim is to give recommendations for better patient outcomes and services. Therefore, the experts were asked to deliberate on alcohol-free based minoxidil formulation to treat AGA from an Indian perspective.
Postdiscussion, a uniform consensus was said to have arrived if more than 75% of panel members agreed to the statement. The present paper is the outcome of aspects presented and discussed in the advisory board meetings.
| Results of the Panel Discussion|| |
Dermatologists consult more than 60 patients a month with hair loss complaints depending on the location and practice. Patients visit the clinics within 2–4 months after noticing excessive hair fall. Most patients try home/Ayurvedic/homeopathic treatment before consulting dermatologists. According to the panel members, 5% topical minoxidil is the drug of choice for the management of AGA. They usually recommend liquid topical formulation with an average duration of treatment of more than a year. Most of the panel members do not prescribe hair serums along with topical treatment. The percentage of agreement given by the expert panel has been mentioned in [Table 4].
| Conclusion|| |
Alcohol-free topical minoxidil provides remarkable benefits to patients with alopecia. It is approved by the CDSCO for AGA. The position paper assessed that alcohol-free or less alcohol minoxidil formulation improves hydration and reduces the scalp's dryness, redness, and itching. In contrast, alcohol-based formulations increase the dryness and redness of the scalp after 15 and 30 days of treatment in men with AGA. The novel minoxidil formulation was better tolerated compared to the alcoholic formulations. Hence, the alcohol-free minoxidil formulation could be a safer and most satisfactory alternative to alcoholic formulations in treating AGA, especially after hair procedure treatments.
All named authors meet the International Committee of Medical Journal Editors (ICMJE) criteria for authorship for this article, take responsibility for the integrity of the work as a whole, and have given their approval for this version to be published. The authors thank Intellimed Healthcare Solutions LLP, Mumbai for medical writing support.
Financial support and sponsorship
The publication fee was paid by Dr. Reddy's Laboratories, India.
Conflicts of interest
Satish Udare, Anita Barua, Anurag Mathur, Dayanand TR, Kapil Jain, Manas Puhan, Pawan Bajaj, Richa Sharma, Sanjay Gamit, V Ramesh, V Venugopal and Vignesh Karthik are members of the advisory board of Dr. Reddy's Laboratories. Monil Yogesh Neena Gala, Snehal Muchhala and Amey Mane are employees of Dr. Reddy's Laboratories.
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[Table 1], [Table 2], [Table 3], [Table 4]