|Year : 2021 | Volume
| Issue : 2 | Page : 67-71
Comparative clinical assessment of 5% minoxidil topical application with supplemental intradermal meso-solution administration for the management of androgenetic alopecia in men
Neha Gupta1, Sarvraj Kohli2
1 Department of Dermatology, Venerology and Leperology, NSCB Government Medical College & Hospital, Jabalpur, Madhya Pradesh, India
2 Jabalpur Hospital & Research Centre, Jabalpur, Madhya Pradesh, India
|Date of Submission||25-Mar-2020|
|Date of Decision||19-Nov-2020|
|Date of Acceptance||08-Nov-2021|
|Date of Web Publication||14-Dec-2021|
Department of Dermatology, Venerology and Leperology, NSCB Government Medical College & Hospital, Jabalpur, Madhya Pradesh.
Source of Support: None, Conflict of Interest: None
Objectives: Androgenetic alopecia (AGA) is characterized by progressive patterned hair loss from the scalp affecting both men and women. The aim of this study was to evaluate the influence of intradermal administration of meso-solution (MS) along with topical application of 5% minoxidil lotion on hair re-growth. Materials and Methods: Sixty healthy adult men (32.6 ± 4.3 years of age) with a history of hair loss completed the 12-month study. They were equally randomized into two groups. Subjects enrolled in Group A (n1 = 30) received once-daily topical application of 5% minoxidil lotion, whereas those in Group B (n2 = 30) received additional intradermal injection of MS (Stem C’rum HL, Caregen Co. Ltd, Anyang-si, Gyeonggi-do, South Korea) using a mesogun every 15 days for 3 months and then once every month for 9 months. Hair re-growth was evaluated using a 7-point rating scale. Results: Data collected were subjected to chi-square test. Results indicate that there is a statistically significant (P < 0.05) increase in hair re-growth in individuals in Group B at 6 months. This progressed to a highly significant (P < 0.001) increase at 9 and 12 months. Conclusion: Intradermal administration of MS using a mesogun along with minoxidil yielded a statistically significant increase in hair re-growth as compared to only minoxidil application.
Keywords: Androgenetic alopecia, hair loss, mesotherapy, minoxidil
|How to cite this article:|
Gupta N, Kohli S. Comparative clinical assessment of 5% minoxidil topical application with supplemental intradermal meso-solution administration for the management of androgenetic alopecia in men. Indian J Drugs Dermatol 2021;7:67-71
|How to cite this URL:|
Gupta N, Kohli S. Comparative clinical assessment of 5% minoxidil topical application with supplemental intradermal meso-solution administration for the management of androgenetic alopecia in men. Indian J Drugs Dermatol [serial online] 2021 [cited 2022 May 20];7:67-71. Available from: https://www.ijdd.in/text.asp?2021/7/2/67/332417
| Introduction|| |
Androgenetic alopecia (AGA) is typically characterized by progressive patterned hair loss from the scalp. Studies to understand its pathogenesis and underlying genetic basis show that the miniaturization of the hair follicle with concomitant familial predisposition is the primary causal factors for the pathogenesis of AGA. Although the transition of some terminal hairs into vellus hair is a secondary sexual characteristic, it becomes a medical condition when the hair loss is excessive, premature, and distressing. The progressive loss of hair also has psychosocial implications for affected individuals, which may lead them to develop a negative image of themselves and thereby a reduced quality of life.
The combination of a strong genetic predilection (polysomal inheritance) and presence of androgens have been known to be causal agents for male AGA. The classical presentation of AGA shows patterned hair loss, beginning in the bitemporal region accompanied by a recession of frontal hair, which is followed by reduction over the vertex. The bald patch so formed enlarges and joins the receding frontal hairline, leaving an island of hair on the frontal scalp. Subsequently, this island of hair disappears and only a thin area remains over the parietal and temporal region. The amount of hair loss is not uniform, affected individuals often experience phases of increased hair loss. Studies show that AGA usually does not start till puberty and the rate of hair loss is extremely variable. It is also observed that by the age of 30 years, approximately 30% of men suffer from AGA, which may increase to 50% upon completing 50 years of age. Also dark-skinned men experience AGA lesser than fairer-skinned men.
Mesotherapy is a nonsurgical aesthetic medical treatment. It was first described by a French Physician Michael Pistor in 1952 as “an allopathic, mild, polyvalent and regional therapeutic procedure.” It was called “meso” therapy because it stands “between” two extreme concepts: on the one hand, there is allopathy, which is toxic, allergenic, and rapid in its side-effects; on the other hand, there is homoeopathy, which is safe, mild, and well-tolerated, and uses minimal doses, but sometimes is too slow in acting. The technique is called also referred to as mesotherapy (from the Greek mesos, meaning “middle”), because the injections are intended for tissues derived from the embryonic mesoderm layer, one of the three primary germ layers in the early embryo, which eventually becomes the supporting and nourishing layers of the skin, containing connective tissue, muscle, subcutaneous fat, and blood vessels. The therapeutic effects result from the chemical action of the products used and the reflex stimulation by the multiple punctures made in different sites. To achieve intended therapeutic results there are several modes of delivering the meso-solutions (MSs) such as mesoguns, mesoneedles, dermarollers, and electroporation machines. Using these devices, microdoses of the drug (MS) are deposited within superficial dermis where the action of drug is required. The injections should be limited to the region of the superficial papillary dermis (1.5–2 mm).
MSs are known to contain human adipocyte conditioned media extract, biotin, copper tri-peptide-1, sh-oligopeptide-2 (CG-interferon-like growth factor 1), sh-polypeptide-1 (CG-b fibroblast like growth factor), and sh-polypeptide-9 (CG-vascular endothelial growth factor). These factors have been proven to increase blood circulation to the dermal papilla (DP) cells and also aid in their survival thereby leading to hair re-growth.
This investigation was conducted to evaluate whether it is advantageous to supplement topical 5% minoxidil application with a commercially available MS (Stem C’rum HL, Caregen Co., South Korea). Stem C’rum HL is dispensed in two vials: one vial contains 100 mg of lyophilized powder and the other contains 5 mL of Stem C’rum HL solution. The ingredients of these two vials are mixed together gently and loaded onto the mesogun. The active ingredients of Stem C’rum HL are human adipocyte conditioned media extract, biotin, copper tripeptide-1, sh-oligopeptide-2 (CG-IGF1), sh-polypeptide-1 (CG-bFGF), and sh-polypeptide-9 (CG-VEGF). The concentration of each growth factor as stated by the manufacturer is 10 ppm per vial. The null hypothesis established was that there is no significant improvement in the management of AGA with intradermal injection of MS to 5% minoxidil lotion.
| Materials and Methods|| |
A total of 90 adult healthy men between 21 and 40 years of age who presented with mild-to-moderate vertex male pattern hair loss according to a modified Norwood/ Hamilton classification scale (III vertex, IV, V, and VI) at the Department of Dermatology, Government Medical College, Ahmedabad, India were recruited in this study. The exclusion criteria of the study were as follows: history of surgical correction of scalp hair, topical minoxidil use in the past 1 year, use of medication with androgenic or anti-androgenic properties, use of finastride, known systemic illnesses, significant aberrations on laboratory reports, or hair loss attributable to other reasons. The subjects were also advised to avoid hair dyes or change their hairstyle.
The study was approved by the Institutional Review Board at Government Medical College, Ahmedabad, India.
A prospective, parallel-arm, single-blind study was designed with two equally distributed groups using “throwing a dice” method (even = Group A, odd = Group B). The hair re-growth assessment was done by the second author. The subjects’ hair re-growth was evaluated over a period of 12 months. Group A (n1 = 45) consisted of subjects who applied topical 5% minoxidil lotion over the scalp once daily, whereas subjects in Group B (n2 = 45) received supplemental intradermal injections of MS (Stem C’rum HL, Caregen Co. Ltd, Anyang-si, Gyeonggi-do, South Korea) (5 mL prepared as explained earlier is evenly injected over 10 sites in the scalp) every 15 days for 3 months followed by once a month injections for 9 months using a U225 meso-injector (Timpac Healthcare Pvt. Ltd., New Delhi, India) along with topical application of 5% minoxidil lotion once daily. The MS used in this study is CE certified, which implies that it is in compliance with the essential requirements of the relevant European health, safety, and environmental protection legislation. Its use with needle mesotherapy is recommended. All photographs were taken by the same device and the subjects were placed at a fixed distance to the camera. The background was kept standardized. Institutional review board approval and informed consent were obtained before patients were entered into each study.
Patients (n = 90) were randomly assigned to the two treatment groups. Patients were asked to report to the department every 3 months for standardized photographs of scalp hair for assessment of hair growth. The assessment of hair re-growth was done by the primary investigator at every time point. Hair re-growth was assessed using a 7-point rating scale compared with baseline (–3 = greatly decreased, –2 = moderately decreased, –1 = slightly decreased, 0 = no change, +1 = slightly increased, +2 = moderately increased, +3 = greatly increased). This scale was adopted from previous investigations.,
Sample size was calculated a priori with adequate power (0.80) to detect a defined difference in hair growth between the two treatment groups. All statistical analyses were performed using the Statistical Package for the Social Sciences software program, version 10.0 for Windows (SPSS, Chicago, Illinois). Comparisons between the intervals were made using chi-square test [Table 1]. In this study, the level of significance was determined as P < 0.05.
|Table 1: Statistical analysis of data pooled from investigator assessment at 3, 6, 9, and 12 months|
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| Results|| |
Of the 90 patients enrolled in the study, 60 patients (Group A [n1 = 30], Group B [n2 = 30]) reported for periodic visits till the end of study period. A total of 24 patients were lost to follow up, 5 patients were removed as they had to receive medication mentioned in the exclusion criteria, and 1 patient developed contact dermatitis due to minoxidil reaction. The CONSORT flowchart is described in [Figure 1].
The mean age of the population was 32.6 ± 4.3 years. Patients had hair loss for a mean average of 4.6 years (3–9 years).
In this study, it was observed that there was no statistically significant difference in hair re-growth at 3 months. However, at 6 months there was a statistically significant increase in hair growth (P < 0.05); this change was progressive at both 9 and 12 months. At both 9 and 12 months, there was a highly significant (P < 0.001) difference between the two treatment groups [Table 1]. The null hypothesis established is thus rejected.
| Discussion|| |
Minoxidil is a potassium channel blocker and leads to new hair growth by causing a vasodilatation of the blood vessels supplying the scalp. Topical application of minoxidil has been previously investigated for the management of AGA and was found to be effective in 20%–40% of these studies. MS contains fibroblast growth factor 7, vascular endothelial growth factor, beta-catenin among other active ingredients. These genes have been identified as candidate genes for the expression of hair growth. They also strengthen the hair shaft.
In this study, it was observed that upon intradermal injection of MS using a meso-injector concomitantly with 5% topical minoxidil application there was a significant increase in hair re-growth as compared to application of 5% topical minoxidil only [Figure 2] and [Figure 3]. Upon using a meso-injector a wound is intentionally created, this causes infiltration of platelet-derived growth factor, epidermal growth factor due to platelet activation causing hair re-growth. Also, there is an activation of stem cells in the hair bulge area. Further, the administration of MS could increase the proliferation of DP cells and stimulate extracellular signal-regulated kinase and Akt signaling in a manner similar to platelet-rich plasma administration. The fibroblast growth factor 7 is a potent hair growth stimuli and upregulates the DP cells. Biomimetic peptides have been shown to promote hair follicle vascularization due to its effect on paracrine interactions between endothelial cells and hair follicle DP cells. Therefore, the MS injections could have caused faster telogen to anagen transition in the subjects in Group B. Our findings are corroborated by previous publications by Dhurat et al., Chaudhari et al. advocating usage of micro-needling and platelet-rich plasma, respectively, and, animal studies by Li et al. using platelet-rich plasma. Thus, it can be said that the addition of intradermal administration of MS promotes blood circulation in the scalp and revitalizes hair follicles, thereby inducing hair growth by increasing the size of hair follicle and staying the process of hair loss.
|Figure 2: Standardized pictures of a subject in Group A at different time intervals|
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|Figure 3: Standardized pictures of a subject in Group B at different time intervals|
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Only one instance of adverse clinical event (contact dermatitis) was reported. This is a known side effect of minoxidil application and has been mentioned previously in the literature. The symptoms subsided after cessation of minoxidil application.
It can be concluded from this study that concomitant injection of MS along with 5% topical minoxidil application leads to a statistically progressive increase in hair re-growth. However, the findings must be treated with caution because of the small sample size of this study. Also SCS may prove to be beneficial in cases that are refractory to minoxidil application; and, for individuals who refuse more invasive surgical interventions.
| Conclusion|| |
- The intradermal administration of SCS using a mesogun along with topical application of 5% minoxidil lotion yields a statistically significant increase in hair re-growth compared to topical application of 5% minoxidil lotion only at 6, 9, and 12 months.
- This is a safe and reliable treatment modality for individuals who do not respond to minoxidil application alone.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
Declaration of patient consent
The authors certify that they have obtained all appropriate patient consent forms. In the form the patient(s) has/have given his/her/their consent for his/her/their images and other clinical information to be reported in the journal. The patients understand that their names and initials will not be published and due efforts will be made to conceal their identity, but anonymity cannot be guaranteed.
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[Figure 1], [Figure 2], [Figure 3]