Dermoscopic evaluation of the efficacy of combination of topical spironolactone 5% and minoxidil 5% solutions in the treatment of androgenetic alopecia, comparative study.

INTRODUCTION

Androgenetic alopecia (AGA) is a common chronic dermatological illness that affects both men and women. ¹ Throughout their lives, it impacts up to 80% of men and 50% of women. ²

It is characterized by gradual thinning, miniaturization, and hair loss at the afflicted locations. The extent and intensity of hair loss vary greatly between frontotemporal recession and residual occipital band, and patients may go through several stages in between. ³

AGA has a multifactorial and polygenetic etiology. It's apparent that it's an androgen-dependent disorder. There is evidence of a hereditary predisposition. ⁴

Topical minoxidil solution or foam in men and minoxidil solution or foam in women is regarded as standard therapy for AGA ⁵. By causing telogen hairs

to enter the anagen stage and extending the anagen period, minoxidil increases hair growth. ⁶

According to current research, using spironolactone as a topical therapy leads to significant medication penetration to the active site while limiting the undesired side effects of oral spironolactone ⁷

Dermoscopy provides for the visualization of morphologic structures that aren't visible with the naked eye, such as perifollicular and interfollicular characteristics, and also alterations in hair shaft thickness and form. The term "trichoscopy" was first introduced in 2006 for the usage of dermoscopy in hair and scalp disorder diagnosis, and it is currently commonly adopted .Trichoscopy is an easy, non-invasive, in-office approach for determining the proper diagnosis in patients suffering from hair loss as well as inflammatory hair problems.⁸

The study's objective was to assess and compare dermoscopically the efficacy of a combination of topical minoxidil solution (5%) and topical spironolactone solution (5%) in treating androgenetic alopecia in both men and women.

PATIENTS AND METHODS

This was a cross-sectional, comparative study. From February 2021to March 2022, cases have been obtained from al-Azhar University Hospital's dermatology outpatient clinic. Patients are divided into three groups; each group is composed of 40 patients, as: Group A was given a 5% topical Minoxidil solution. Group B was given a 5% topical spironolactone solution. Group C received a 5% topical spironolactone solution mixed with a 5% topical Minoxidil solution.

Inclusion criteria: Age: 20–50 years old. Patients have had no treatment in the last 3 months for AGA, and all patients are given a diagnosis of AGA based on their history and clinical examination, with varying levels of hair loss according to the Norwood-Hamilton scale for men's pattern baldness and the Ludwig scale for women's pattern loss of hair.

Exclusion criteria: Patients with alopecia other than AGA, autoimmune diseases causing hair loss, male patients with a history of sexual dysfunction and infertility, pregnant and lactating women, patients with anuria, acute renal insufficiency, acute renal failure, Addisons disease and hypersensitivity to spironolactone and patients with cardiovascular disorders.

All patients will be subjected to the following: Thorough history taking with emphasis on sexual and CVS history. General examination, blood pressure, pulse, and heart rate monitoring, and full scalp examination.

The patients have been asked to apply the solution twice a day in a dose of 1 ml, gently massaging their scalps.

Dermoscopic evaluation (DermLite DL4) and imaging every two weeks for three months for the detection of signs of hair regrowth and a decrease in AGA activity. 

Method of preparation of solutions:

Preparation of spironolactone 5% solution: One gram of active ingredient spironolactone is dissolved in 20 ml of isopropylalcohol to get 5% solution. Clear solution occurred after shaking; gentle heating over waterbath 45-50 c, closure and labeling then solution is kept in room temperature for further use.

Preparation of mixture of minoxidil 5% solution and spironolactone 5% solution: 5ml of minoxidil (5%) is mixed with 5ml of spironolactone (5%). The solution is shaken for 10 minutes and put in a waterbath for 20 minutes until a clear solution is obtained, then closed, labeled and kept at room temperature for further use.

Data collection: All participants in this study were recruited from the Al Hussein and Sayed Galal University Hospitals' dermatology and venereology outpatient clinics at Al-Azhar University in Cairo.

Ethical Approval: Before beginning this research, approval from Al-Azhar University's medical ethics committee will be obtained.

The study procedures will be explained to all patients, and their written consent will be obtained.

Evaluation:

Quartile grading scale for improvement: Two independent blinded dermatologists were asked to compare digital images taken three months after therapy with baseline photos of hair condition using a quartile grading scale as follows: poor improvements (0–24%), mild improvements (25–50%), moderate improvements (51–75%), and great improvements (76–100%).

Patient satisfaction: The patients were requested to evaluate their own level of satisfaction by giving themselves a score of 0–3 points as follows: poor satisfaction equals 0, mild satisfaction equals 1, moderate satisfaction equals 2, and high satisfaction equals 3.

Statistical analysis: The Statistical Program for Social Science (SPSS) version 26 has been employed to analyze the data.

RESULTS

F: One way Anva  Test.                          NS: p-value > 0.05 is regarded as non-significant.

Table 1: Comparison of the studied groups in terms of age & duration

There have been no statistically significant differences (p-value > 0.05) between the examined groups in terms of age and duration of disease. Table (1)

X2: Chi square Test.                                               NS: p-value > 0.05 is regarded as non-significant.

Table 2: Comparison of the studied groups in terms of sex, onset & course

There have been no statistically significant differences (p-value > 0.05) between the examined groups in terms of sex, onset, & course. Table (2)

 F: One way Anva Test.                          NS: p-value > 0.05 is regarded as non-significant.

HS: p-value < 0.05 is regarded as highly significant.

Table 3: Comparison of the studied groups in terms of dermoscopic features (After one month and half)

There have been no statistically significant differences (p-value > 0.05) between the examined groups in terms of dermoscopic features after one month and half treatment (hair shaft diversity, yellow dots , peripilar sign, honeycomb hyperpigmentation, follicular unit with only one emerging hair & upright regrowing hair). There have been statistically significant differences (p-value < 0.05) between the examined groups in terms of dermoscopic features after one month and half treatment (vellus hair). Table (3)

Fig. 1: Comparison of examined groups in terms of diversity of hair shaft, yellow dots, peripilar sign, Vellus hair, honeycomb hyperpigmentation, follicular unit with only one emerging hair and upright regrowing hair (After three months)

There have been statistically significant differences (p-value < 0.05) between the examined groups in terms of dermoscopic features after three months of treatment (vellus hair). There have been no statistically significant differences (p-value > 0.05) between the examined groups in terms of dermoscopic features after three months of treatment (hair shaft diversity, yellow dots, peripilar sign, honeycomb hyperpigmentation, follicular unit with only one emerging hair & upright regrowing hair). Figure (1)

Fig. 2: Comparison between the diversity of hair shafts, yellow dots, peripilar sign, Vellus hair, honeycomb hyperpigmentation, follicular unit with only one emerging hair and upright regrowing hair (before , after one month, and half  & after three months) in group A

There have been no statistically significant differences (p-value > 0.05) among (yellow dots, peripilar sign, and honeycomb hyperpigmentation) before, after one month, and half & after three months of treatment in group A. There have been statistically significant differences (p-value < 0.001) among (hair shaft diversity, vellus hair, follicular unit with only one emerging hair & upright regrowing hair) before, after one month, and half & after three months of treatment in group A. Figure (2)

Fig. 3: Comparison between diversity of hair shaft, yellow dots, Peripilar sign, Vellus hair, honeycomb hyperpigmentation, follicular unit with only one emerging hair and upright regrowing hair (before, after one month, and half  & after three months) in group B.

There have been no statistically significant differences (p-value > 0.05) among (yellow dots, peripilar sign, honeycomb hyperpigmentation, and follicular unit with only one emerging hair) before, after one month, and half  & after three months of treatment in group B. There have been statistically significant differences (p-value < 0.001) among (diversity of hair shaft, vellus hair, and upright regrowing hair) before, after one month, and a half, & after three months of treatment in group B. Figure (3)

Fig. 4: comparison between the diversity of hair shaft, yellow dots, peripilar sign, Vellus hair, honeycomb hyperpigmentation, follicular unit with only one emerging hair and upright regrowing hair (before, after one month, and half & after three months) in group C.

There have been no statistically significant differences (p-value > 0.05) among (yellow dots, peripilar sign, and honeycomb hyperpigmentation) before, after one month, and half & after three months of treatment in group C. There have been statistically significant differences (p-value < 0.001) among (hair shaft diversity, vellus hair, follicular unit with only one emerging hair & upright regrowing hair), before, after one month and a half, & after three months of treatment in group C. Figure (4)

X2: Chi square Test.                HS: p-value > 0.001 is regarded as non-significant.

Table 4: Comparison of the studied groups in terms of the Quartile grading scale for improvement:

There have been statistically significant differences between the examined groups in terms of the degree of Quartile grading scale for improvement. Table (4)

X2: Chi square Test.    HS: p-value > 0.001 is regarded as non-significant.

Table 5: comparison between studied groups as to patient’s satisfacation

There have been statistically significant differences between the examined groups in terms of patient satisfaction. Table (5)

Fig. 5: A female patient, 39 years old, complained of 3 years of diffuse loss of hair. The clinical image (A) indicates diffuse hair thinning in the frontal, middle, and temporoparietal areas of the scalp, but the frontal hair line is retained (as per Ludwig's FPHL classification, grade II). The first visit's dermoscopy (B, C, D) reveals the diversity of hair shafts (blue arrows) and vellus hairs (red arrows), which is suggestive of androgenic alopecia. In comparison to the occipital area, which is seen in E (clinical photo), F (dermoscopic photo)

Fig. 6: represents group (B) after treatment and follow-up for three months. Clinical photos (G) showed moderate improvement. Dermoscopy (H, I, J) showed an increase in hair shaft diameter and a reduction in hair shaft diversity (green triangle), decreased vellus hairs, and the appearance of upright regrowing hair (blue dot). In comparison to the occipital area, which is seen in K (clinical photo), and L (dermoscopic photo).

Fig. 7: A female patient, 24 years old, with a year's worth of diffuse hair loss. The clinical image (A) indicates diffuse hair thinning in the frontal and middle areas of the scalp, but the frontal hair line is retained (as per Ludwig's FPHL classification, grade II). First visit dermoscopy (B, C, D) reveals hair shaft diversity (blue arrows) and vellus hairs (red arrows), which is suggestive of androgenic alopecia. In comparison to the occipital area, which is seen in E (clinical photo), F (dermoscopic photo).

Fig. 8: represents group (A) after treatment and follow-up for three months.

Clinical photos (G) showed moderate improvement. Dermoscopy (H, I, J) showed an increased hair shaft diameter, a reduction in hair shaft diversity (green triangle), decreased vellus hairs, and the appearance of upright regrowing hair (blue dot). In comparison to the occipital area, which is seen in K (clinical photo), L (dermoscopic photo).

Fig. 9: A female patient, 37 years old, complained of 3 years of diffuse loss of hair. The clinical image (A) indicates diffuse hair thinning in the frontal, middle, and temporoparietal areas of the scalp, but the frontal hair line is retained (as per Ludwig's FPHL classification, grade II). The first visit's dermoscopy (B, C, D) reveals the diversity of hair shafts (blue arrows), vellus hairs (red arrows), which is suggestive of androgenic alopecia. In comparison to the occipital area, which is seen in E (clinical photo), F (dermoscopic photo).

Fig. 10: represents group (C) after treatment and follow-up for three months. Clinical photos (G) showed high improvement. Dermoscopy (H, I, J) showed an increased hair shaft diameter, a reduction in hair shaft diversity (green triangle), a decrease in vellus hairs, and the appearance of upright regrowing hair (blue dot). In comparison to the occipital area, which is seen in K (clinical photo), L (dermoscopic photo).