Journal of Cosmetic Dermatology

<jats:title>ABSTRACT</jats:title><jats:sec><jats:title>Background</jats:title><jats:p>Society values a full head of hair. Therefore, androgenetic hair loss (AGA), though medically benign, can cause significant emotional distress. There is strong demand for alternative (nonconventional, over‐the‐counter) AGA treatments. It is important to have evidence on the efficacy of these treatments for AGA—especially in comparison with treatments that are approved by the United States Food and Drug Administration (FDA), such as oral finasteride and topical minoxidil.</jats:p></jats:sec><jats:sec><jats:title>Aims</jats:title><jats:p>Following a systematic review, we conducted a network meta‐analysis (NMA) to determine the relative efficacy of conventional monotherapies and selected alternative (nonconventional, over‐the‐counter) products for male AGA.</jats:p></jats:sec><jats:sec><jats:title>Methods</jats:title><jats:p>We conducted a Bayesian NMA under a fixed effect model with uniform priors; the NMA estimated relative effects—as per mean difference (MD), along with the 95% credible interval (CI)—and surface under the cumulative ranking curve (SUCRA) values. We also assessed study‐level evidence quality. Eligible studies were identified through systematic searches (without date restrictions) in PubMed and Scopus on April 30, 2025. The main outcome measure was change in total hair density at 24 weeks from baseline (in hairs/cm<jats:sup>2</jats:sup>).</jats:p></jats:sec><jats:sec><jats:title>Results and Conclusion</jats:title><jats:p>We found 24 eligible trials—where the relative efficacy of eight conventional monotherapies and seven alternative (nonconventional, over‐the‐counter) products was determined. The current NMA study confirms the efficacy of conventional monotherapies such as oral dutasteride, topical/oral minoxidil, and oral/topical finasteride for male AGA. We have provided guidance regarding the relative efficacy of some alternative (nonconventional, over‐the‐counter) agents (e.g., melatonin (topical) and rosemary oil (topical)) compared to conventional treatments.</jats:p></jats:sec>

publication_history

received

accepted

published

Multi‐Therapies in Androgenetic Alopecia: Review and Clinical Experiences

Dermatologic Therapy

Evidence for a Polygenic Contribution to Androgenetic Alopecia

British Journal of Dermatology

Female Pattern Hair Loss

Journal of the American Academy of Dermatology

Clinical Study to Evaluate the Efficacy and Safety of a Hair Serum Product in Healthy Adult Male and Female Volunteers With Hair Fall

Clinical, Cosmetic and Investigational Dermatology

The Psychosocial Consequences of Androgenetic Alopecia: A Review of the Research Literature

Psychosocial Impact of Androgenetic Alopecia on Men: A Systematic Review and Meta‐Analysis

Psychology, Health & Medicine

Experimental and Early Investigational Drugs for Androgenetic Alopecia

Expert Opinion on Investigational Drugs

Nutraceuticals for Androgenetic Alopecia

Journal of Clinical and Aesthetic Dermatology

Medical Treatments for Male and Female Pattern Hair Loss

Controversies in the Treatment of Androgenetic Alopecia: The History of Finasteride

The Booming Business of Hair Loss

Trends in Biotechnology

An Overview of Commonly Used Natural Alternatives for the Treatment of Androgenetic Alopecia, With Special Emphasis on Rosemary Oil

The PRISMA Extension Statement for Reporting of Systematic Reviews Incorporating Network Meta‐Analyses of Health Care Interventions: Checklist and Explanations

Annals of Internal Medicine

Automation of Duplicate Record Detection for Systematic Reviews: Deduplicator

Systematic Reviews

Risk‐Of‐Bias VISualization (Robvis): An R Package and Shiny Web App for Visualizing Risk‐Of‐Bias Assessments

Research Synthesis Methods

Automated Generation of Node‐Splitting Models for Assessment of Inconsistency in Network Meta‐Analysis

The Kilim Plot: A Tool for Visualizing Network Meta‐Analysis Results for Multiple Outcomes

Comparative Efficacy of Topical Finasteride (0.25%) in Combination With Minoxidil (5%) Against 5% Minoxidil or 0.25% Finasteride Alone in Male Androgenetic Alopecia: A Pilot, Randomized Open‐Label Study

International Journal of Trichology

Efficacy of the Association of Topical Minoxidil and Topical Finasteride Compared to Their Use in Monotherapy in Men With Androgenetic Alopecia: A Prospective, Randomized, Controlled, Assessor Blinded, 3‐Arm, Pilot Trial

Effects of Watercress Extract Fraction on R‐Spondin 1‐Mediated Growth of Human Hair

International Journal of Cosmetic Science

Efficacy and Safety of Topical Finasteride Spray Solution for Male Androgenetic Alopecia: A Phase III, Randomised, Controlled Clinical Trial

Journal of the European Academy of Dermatology and Venereology

Efficacy and Safety of Oral Minoxidil 5 Mg Once Daily in the Treatment of Male Patients With Androgenetic Alopecia: An Open‐Label and Global Photographic Assessment

Dermatology and Therapy (Heidelberg)

Comparison of Efficacy of Platelet‐Rich Plasma Therapy With or Without Topical 5% Minoxidil in Male‐Type Baldness: A Randomized, Double‐Blind Placebo Control Trial

Indian Journal of Dermatology, Venereology and Leprology

Superiority of Dutasteride Over Finasteride in Hair Regrowth and Reversal of Miniaturization in Men With Androgenetic Alopecia: A Randomized Controlled Open‐Label, Evaluator‐Blinded Study

A 6‐Month, Randomized, Double‐Blind, Placebo‐Controlled Study Evaluating the Ability of a Marine Complex Supplement to Promote Hair Growth in Men With Thinning Hair

Rosemary Oil vs Minoxidil 2% for the Treatment of Androgenetic Alopecia: A Randomized Comparative Trial

Skinmed

A Randomized, Active‐ and Placebo‐Controlled Study of the Efficacy and Safety of Different Doses of Dutasteride Versus Placebo and Finasteride in the Treatment of Male Subjects With Androgenetic Alopecia

Efficacy, Safety, and Tolerability of Dutasteride 0.5 Mg Once Daily in Male Patients With Male Pattern Hair Loss: A Randomized, Double‐Blind, Placebo‐Controlled, Phase III Study

Comparing the Therapeutic Effects of Finasteride Gel and Tablet in Treatment of the Androgenetic Alopecia

Investigation of the Topical Application of Procyanidin Oligomers From Apples to Identify Their Potential Use as a Hair‐Growing Agent

Clinical Dose Ranging Studies With Finasteride, a Type 2 5α‐Reductase Inhibitor, in Men With Male Pattern Hair Loss

Finasteride in the Treatment of Men With Androgenetic Alopecia. Finasteride Male Pattern Hair Loss Study Group

Ketoconazole Shampoo: Effect of Long‐Term Use in Androgenic Alopecia

Dermatology

Androgenetic Alopecia in Men: The Scale of the Problem and Prospects for Treatment

International Journal of Clinical Practice

Topical Minoxidil in Androgenetic Alopecia Scandinavian and Middle East Experience

International Journal of Dermatology

Treatment of Male Pattern Alopecia Using Topical Minoxidil in The Netherlands

The German Double‐Blind Placebo‐Controlled Evaluation of Topical Minoxidil Solution in the Treatment of Early Male Pattern Baldness

2% Topical Minoxidil Solution in Male‐Pattern Baldness: Preliminary European Results

Dermatologica

Dose‐Response Study of Topical Minoxidil in Male Pattern Baldness

Treatment of Male Androgenetic Alopecia With Topical Products Containing S Erenoa Repens Extract

Australasian Journal of Dermatology

Topical Melatonin for Treatment of Androgenetic Alopecia

Network Meta‐Analysis: A Technique to Gather Evidence From Direct and Indirect Comparisons

Pharmacy Practice (Granada)

Efficacy and Safety of Microneedling Radiofrequency in Patterned Hair Loss

Journal of Cutaneous and Aesthetic Surgery

Standardized Scalp Massage Results in Increased Hair Thickness by Inducing Stretching Forces to Dermal Papilla Cells in the Subcutaneous Tissue

Eplasty

A Systematic Review and Meta‐Analysis of Randomized Controlled Trials of United States Food and Drug Administration‐Approved, Home‐Use, Low‐Level Light/Laser Therapy Devices for Pattern Hair Loss: Device Design and Technology

Natural Products for Male Androgenetic Alopecia

Investigation of Topical Application of Procyanidin B‐2 From Apple to Identify Its Potential Use as a Hair Growing Agent

Phytomedicine

SULT1A1 (Minoxidil Sulfotransferase) Enzyme Booster Significantly Improves Response to Topical Minoxidil for Hair Regrowth

Minoxidil Sulfotransferase Enzyme (SULT1A1) Genetic Variants Predicts Response to Oral Minoxidil Treatment for Female Pattern Hair Loss

Sulfotransferase SULT1A1 Activity in Hair Follicle, a Prognostic Marker of Response to the Minoxidil Treatment in Patients With Androgenetic Alopecia: A Review

Postepy Dermatologii I Alergologii

Relative Efficacy of Minoxidil and the 5‐Alpha Reductase Inhibitors in Androgenetic Alopecia Treatment of Male Patients: A Network Meta‐Analysis

JAMA Dermatology

The Comparative Effects of Monotherapy With Topical Minoxidil, Oral Finasteride, and Topical Finasteride in Postmenopausal Women With Pattern Hair Loss: A Retrospective Cohort Study

Skin Appendage Disorders

Pumpkin Seed Oil vs. Minoxidil 5% Topical Foam for the Treatment of Female Pattern Hair Loss: A Randomized Comparative Trial

Safety and Efficacy of Rice Bran Supercritical CO2 Extract for Hair Growth in Androgenic Alopecia: A 16‐Week Double‐Blind Randomized Controlled Trial

Biological & Pharmaceutical Bulletin

Society values a full head of hair. Therefore, androgenetic hair loss (AGA), though medically benign, can cause significant emotional distress. There is strong demand for alternative (nonconventional, over-the-counter) AGA treatments. It is important to have evidence on the efficacy of these treatments for AGA-especially in comparison with treatments that are approved by the United States Food and Drug Administration (FDA), such as oral finasteride and topical minoxidil.
Following a systematic review, we conducted a network meta-analysis (NMA) to determine the relative efficacy of conventional monotherapies and selected alternative (nonconventional, over-the-counter) products for male AGA.
We conducted a Bayesian NMA under a fixed effect model with uniform priors; the NMA estimated relative effects-as per mean difference (MD), along with the 95% credible interval (CI)-and surface under the cumulative ranking curve (SUCRA) values. We also assessed study-level evidence quality. Eligible studies were identified through systematic searches (without date restrictions) in PubMed and Scopus on April 30, 2025. The main outcome measure was change in total hair density at 24 weeks from baseline (in hairs/cm
We found 24 eligible trials-where the relative efficacy of eight conventional monotherapies and seven alternative (nonconventional, over-the-counter) products was determined. The current NMA study confirms the efficacy of conventional monotherapies such as oral dutasteride, topical/oral minoxidil, and oral/topical finasteride for male AGA. We have provided guidance regarding the relative efficacy of some alternative (nonconventional, over-the-counter) agents (e.g., melatonin (topical) and rosemary oil (topical)) compared to conventional treatments.

Relative Efficacy of Conventional Monotherapies and Select Nonconventional, Over-the-Counter Products for Male Androgenetic Alopecia: A Network Meta-Analysis Study.

Relative Efficacy of Conventional Monotherapies and Select Nonconventional, Over‐the‐Counter Products for Male Androgenetic Alopecia: A Network Meta‐Analysis Study

<jats:sec id="ab-dcs240009-4"><jats:title>Importance</jats:title><jats:p>The results of small studies suggest that off-label use of low-dose oral minoxidil (LDOM) may be safe and effective for patients with hair loss, but larger trials and standardized guidelines are lacking.</jats:p></jats:sec><jats:sec id="ab-dcs240009-5"><jats:title>Objective</jats:title><jats:p>To create an expert consensus statement for LDOM prescribing for patients with hair loss.</jats:p></jats:sec><jats:sec id="ab-dcs240009-6"><jats:title>Evidence Review</jats:title><jats:p>The current literature on the pharmacological properties, adverse effect profile, and use of LDOM for patients with hair loss was reviewed. Topics of interest were identified, and a modified Delphi consensus process was created. A total of 43 hair loss specialist dermatologists from 12 countries participated in a modified Delphi process. Consensus was reached if at least 70% agreed or strongly agreed on a 5-point Likert scale.</jats:p></jats:sec><jats:sec id="ab-dcs240009-7"><jats:title>Findings</jats:title><jats:p>Over 4 survey rounds, 180 items in the first round, 121 items in the second round, 16 items in the third round, and 11 items in the fourth round were considered and revised. A total of 76 items achieved consensus including diagnoses for which LDOM may provide direct or supportive benefit, indications for LDOM compared to topical minoxidil, dosing for adults (18 years and older) and adolescents (aged 12 to 17 years), contraindications, precautions, baseline evaluation, monitoring, adjunctive therapy, and specialty consultation. Pediatric use and dosing items for children younger than 12 years, and LDOM titration protocols fell short of consensus.</jats:p></jats:sec><jats:sec id="ab-dcs240009-8"><jats:title>Conclusions and Relevance</jats:title><jats:p>This international expert consensus statement regarding the off-label prescribing of LDOM for patients with hair loss can help guide clinical practice until more data emerge. Hair loss experts with experience treating pediatric patients were underrepresented on this expert panel. Future research should investigate best practices for LDOM use in pediatric patients. Other critical topics for further investigation include the comparative efficacy of topical minoxidil vs oral minoxidil, the safety of oral minoxidil for patients with a history of allergic contact dermatitis to topical minoxidil, the long-term safety of LDOM, and the use of other off-label forms of minoxidil, such as compounded formulations of oral minoxidil and sublingual minoxidil. As additional evidence-based data emerge, these recommendations should be updated.</jats:p></jats:sec>

Hair loss: common causes and treatment.

Am Fam Physician

Treatment of hair loss.

N Engl J Med

Diagnosis and treatment of nonscarring hair loss in primary care in 2021.

JAMA

Topical and oral minoxidil for hair disorders in pediatric patients: what do we know so far?

Dermatol Ther

Hair disorders in cancer survivors.

J Am Acad Dermatol

Minoxidil: a comprehensive review.

J Dermatolog Treat

Oral minoxidil treatment for hair loss: a review of efficacy and safety.

Safety of low-dose oral minoxidil for hair loss: a multicenter study of 1404 patients.

Safety of low-dose oral minoxidil treatment for hair loss: a systematic review and pooled-analysis of individual patient data.

Prospective cardiovascular evaluation with 24-hour Holter and 24-hour ambulatory blood pressure monitoring in men using 5-mg oral minoxidil for androgenetic alopecia.

Combination tofacitinib and oral minoxidil treatment for severe alopecia areata.

Systemic minoxidil for hair disorders in pediatric patients: a safety and tolerability review.

Int J Dermatol

Low-dose oral minoxidil for treatment of androgenetic alopecia and telogen effluvium in a pediatric population: a descriptive study.

Treatment for central centrifugal cicatricial alopecia—Delphi consensus recommendations.

Survey of dermatology practitioners’ opinions and prescribing habits of oral minoxidil for the treatment of androgenetic alopecia.

J Drugs Dermatol

Female pattern hair loss: a pilot study investigating combination therapy with low-dose oral minoxidil and spironolactone.

Treatment of chronic telogen effluvium with oral minoxidil: a retrospective study.

F1000Res

Low-dose oral minoxidil improves hair density in traction alopecia.

Low-dose oral minoxidil for androgenetic alopecia is not associated with clinically significant blood-pressure changes: a retrospective study.

Low-dose oral minoxidil improves hair length and global hair density in short anagen syndrome.

Trichorrhexis nodosa improving with oral minoxidil: a case report.

Clin Exp Dermatol

Serious complication of low-dose oral minoxidil for hair loss.

JAAD Case Rep

Pericardial, pleural effusion and anasarca: a rare complication of low-dose oral minoxidil for hair loss.

The Delphi technique: myths and realities.

J Adv Nurs

SQUIRE 2.0 (Standards for QUality Improvement Reporting Excellence): revised publication guidelines from a detailed consensus process.

BMJ Qual Saf

The REDCap consortium: building an international community of software platform partners.

J Biomed Inform

The Alopecia Areata Consensus of Experts (ACE) study: results of an international expert opinion on treatments for alopecia areata.

The Alopecia Areata Consensus of Experts (ACE) study part II: results of an international expert opinion on diagnosis and laboratory evaluation for alopecia areata.

A global eDelphi exercise to identify core domains and domain items for the development of a Global Registry of Alopecia Areata Disease Severity and Treatment Safety (GRASS).

JAMA Dermatol

The Alopecia Areata Severity and Morbidity Index (ASAMI) study: results from a global expert consensus exercise on determinants of alopecia areata severity.

The International TREatment of ATopic Eczema (TREAT) Registry Taskforce: an initiative to harmonize data collection across national atopic eczema photo- and systemic therapy registries.

J Invest Dermatol

TREatment of ATopic eczema (TREAT) Registry Taskforce: protocol for an international Delphi exercise to identify a core set of domains and domain items for national atopic eczema registries.

Trials

TREatment of ATopic eczema (TREAT) Registry Taskforce: an international Delphi exercise to identify a core set of domains and domain items for national atopic eczema photo- and systemic therapy registries.

Br J Dermatol

How safe is prescribing oral minoxidil in patients allergic to topical minoxidil?

The results of small studies suggest that off-label use of low-dose oral minoxidil (LDOM) may be safe and effective for patients with hair loss, but larger trials and standardized guidelines are lacking.
To create an expert consensus statement for LDOM prescribing for patients with hair loss.
The current literature on the pharmacological properties, adverse effect profile, and use of LDOM for patients with hair loss was reviewed. Topics of interest were identified, and a modified Delphi consensus process was created. A total of 43 hair loss specialist dermatologists from 12 countries participated in a modified Delphi process. Consensus was reached if at least 70% agreed or strongly agreed on a 5-point Likert scale.
Over 4 survey rounds, 180 items in the first round, 121 items in the second round, 16 items in the third round, and 11 items in the fourth round were considered and revised. A total of 76 items achieved consensus including diagnoses for which LDOM may provide direct or supportive benefit, indications for LDOM compared to topical minoxidil, dosing for adults (18 years and older) and adolescents (aged 12 to 17 years), contraindications, precautions, baseline evaluation, monitoring, adjunctive therapy, and specialty consultation. Pediatric use and dosing items for children younger than 12 years, and LDOM titration protocols fell short of consensus.
This international expert consensus statement regarding the off-label prescribing of LDOM for patients with hair loss can help guide clinical practice until more data emerge. Hair loss experts with experience treating pediatric patients were underrepresented on this expert panel. Future research should investigate best practices for LDOM use in pediatric patients. Other critical topics for further investigation include the comparative efficacy of topical minoxidil vs oral minoxidil, the safety of oral minoxidil for patients with a history of allergic contact dermatitis to topical minoxidil, the long-term safety of LDOM, and the use of other off-label forms of minoxidil, such as compounded formulations of oral minoxidil and sublingual minoxidil. As additional evidence-based data emerge, these recommendations should be updated.

Low-Dose Oral Minoxidil Initiation for Patients With Hair Loss: An International Modified Delphi Consensus Statement.

Low-Dose Oral Minoxidil Initiation for Patients With Hair Loss

<jats:sec><jats:title>Importance</jats:title><jats:p>There has been increased interest in low-dose oral minoxidil for androgenetic alopecia (AGA) treatment. However, the efficacy of oral minoxidil for male AGA is yet to be evaluated in comparative therapeutic trials.</jats:p></jats:sec><jats:sec><jats:title>Objective</jats:title><jats:p>To compare the efficacy, safety, and tolerability of daily oral minoxidil, 5 mg, vs twice-daily topical minoxidil, 5%, for 24 weeks in the treatment of male AGA.</jats:p></jats:sec><jats:sec><jats:title>Design, Setting, and Participants</jats:title><jats:p>This double-blind, placebo-controlled randomized clinical trial was conducted at a single specialized clinic in Brazil. Eligible men with AGA aged 18 to 55 years classified using the Norwood-Hamilton scale as 3V, 4V, or 5V were included and randomized. Data were collected from January to December 2021, and data were analyzed from September 2022 to February 2023.</jats:p></jats:sec><jats:sec><jats:title>Interventions</jats:title><jats:p>Participants were randomized 1:1 into 2 groups: oral minoxidil, 5 mg, daily and topical placebo solution; or 1 mL of topical minoxidil, 5%, twice daily and oral placebo for 24 weeks.</jats:p></jats:sec><jats:sec><jats:title>Main Outcomes and Measures</jats:title><jats:p>The primary outcome was change in terminal hair density on the frontal and vertex regions of the scalp. The secondary outcomes were change in total hair density and photographic evaluation.</jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><jats:p>Among 90 enrolled participants, 68 completed the study; of these, the mean (SD) age was 36.6 (7.8) years. A total of 33 participants were enrolled in the oral minoxidil group and 35 in the topical treatment group. Both groups were homogenous in terms of demographic data and AGA severity. For the frontal area, the mean change from baseline to week 24 between groups was 3.1 hairs per cm<jats:sup>2</jats:sup> (95% CI, −18.2 to 21.5; <jats:italic>P</jats:italic> = .27) for terminal hair density and 2.6 hairs per cm<jats:sup>2</jats:sup> (95% CI, −10.3 to 15.8; <jats:italic>P</jats:italic> = .32) for total hair density. For the vertex area, the mean change from baseline to week 24 was 23.4 hairs per cm<jats:sup>2</jats:sup> (95% CI, −0.3 to 43.0; <jats:italic>P</jats:italic> = .09) for terminal density and 5.5 hairs per cm<jats:sup>2</jats:sup> (95% CI, −12.5 to 23.5; <jats:italic>P</jats:italic> = .32) for total hair density. According to the photographic analysis, oral minoxidil was superior to topical minoxidil on the vertex (24%; 95% CI, 0 to 48; <jats:italic>P</jats:italic> = .04) but not on the frontal scalp (12%; 95% CI, −12 to 36; <jats:italic>P</jats:italic> = .24). The most common adverse effects in the oral minoxidil group were hypertrichosis (22 of 45 [49%]) and headache (6 of 45 [14%]).</jats:p></jats:sec><jats:sec><jats:title>Conclusions and Relevance</jats:title><jats:p>In this study, oral minoxidil, 5 mg, once per day for 24 weeks did not demonstrate superiority over topical minoxidil, 5%, twice per day in men with AGA.</jats:p></jats:sec><jats:sec><jats:title>Trial Registration</jats:title><jats:p>Brazilian Registry of Clinical Trials Identifier: <jats:ext-link xmlns:xlink="http://www.w3.org/1999/xlink" ext-link-type="uri" xlink:href="https://ensaiosclinicos.gov.br/rg/RBR-252w9r">RBR-252w9r</jats:ext-link></jats:p></jats:sec>

Prevalence of male and female pattern hair loss in Maryborough.

J Investig Dermatol Symp Proc

Female pattern hair loss: a clinical and pathophysiological review.

An Bras Dermatol

The psychosocial consequences of androgenetic alopecia: a review of the research literature.

Relative efficacy of minoxidil and the 5-a reductase inhibitors in androgenetic alopecia treatment of male patients: a network meta-analysis.

Post-finasteride syndrome.

Is topical minoxidil solution effective on androgenetic alopecia in routine daily practice?

Oral minoxidil for hair loss: update and perspectives.

Hair Transplant Forum Int

Classification of male-pattern hair loss.

Int J Trichology

Estimating sample sizes for repeated measurement designs.

Control Clin Trials

Follicular map: a novel approach to quantitative trichoscopy.

Skin Appendage Disord

Efficiency of hair detection in hair-to-hair matched trichoscopy.

A randomized, double-blind, multicenter comparison of the efficacy and tolerability of Restylane versus Zyplast for the correction of nasolabial folds.

Dermatol Surg

Anomalous values and missing data in clinical and experimental studies.

J Vasc Bras

Assessing normality of data in clinical and experimental trials.

Analysis of longitudinal data from animals with missing values using SPSS.

Nat Protoc

P value and effect-size in clinical and experimental studies.

Reversal of baldness in patient receiving minoxidil for hypertension.

Efficacy and safety of oral minoxidil 5 mg once daily in the treatment of male patients with androgenetic alopecia: an open-label and global photographic assessment.

Dermatol Ther (Heidelb)

Post—COVID-19 hair loss: prevalence and associated factors among 5,891 patients.

Minoxidil 1 mg oral versus minoxidil 5% topical solution for the treatment of female-pattern hair loss: a randomized clinical trial.

Adverse effects of low-dose oral minoxidil for androgenetic alopecia in 435 patients.

A randomized, single-blind trial of 5% minoxidil foam once daily versus 2% minoxidil solution twice daily in the treatment of androgenetic alopecia in women.

There has been increased interest in low-dose oral minoxidil for androgenetic alopecia (AGA) treatment. However, the efficacy of oral minoxidil for male AGA is yet to be evaluated in comparative therapeutic trials.
To compare the efficacy, safety, and tolerability of daily oral minoxidil, 5 mg, vs twice-daily topical minoxidil, 5%, for 24 weeks in the treatment of male AGA.
This double-blind, placebo-controlled randomized clinical trial was conducted at a single specialized clinic in Brazil. Eligible men with AGA aged 18 to 55 years classified using the Norwood-Hamilton scale as 3V, 4V, or 5V were included and randomized. Data were collected from January to December 2021, and data were analyzed from September 2022 to February 2023.
Participants were randomized 1:1 into 2 groups: oral minoxidil, 5 mg, daily and topical placebo solution; or 1 mL of topical minoxidil, 5%, twice daily and oral placebo for 24 weeks.
The primary outcome was change in terminal hair density on the frontal and vertex regions of the scalp. The secondary outcomes were change in total hair density and photographic evaluation.
Among 90 enrolled participants, 68 completed the study; of these, the mean (SD) age was 36.6 (7.8) years. A total of 33 participants were enrolled in the oral minoxidil group and 35 in the topical treatment group. Both groups were homogenous in terms of demographic data and AGA severity. For the frontal area, the mean change from baseline to week 24 between groups was 3.1 hairs per cm2 (95% CI, -18.2 to 21.5; P = .27) for terminal hair density and 2.6 hairs per cm2 (95% CI, -10.3 to 15.8; P = .32) for total hair density. For the vertex area, the mean change from baseline to week 24 was 23.4 hairs per cm2 (95% CI, -0.3 to 43.0; P = .09) for terminal density and 5.5 hairs per cm2 (95% CI, -12.5 to 23.5; P = .32) for total hair density. According to the photographic analysis, oral minoxidil was superior to topical minoxidil on the vertex (24%; 95% CI, 0 to 48; P = .04) but not on the frontal scalp (12%; 95% CI, -12 to 36; P = .24). The most common adverse effects in the oral minoxidil group were hypertrichosis (22 of 45 [49%]) and headache (6 of 45 [14%]).
In this study, oral minoxidil, 5 mg, once per day for 24 weeks did not demonstrate superiority over topical minoxidil, 5%, twice per day in men with AGA.
Brazilian Registry of Clinical Trials Identifier: RBR-252w9r.

Oral Minoxidil vs Topical Minoxidil for Male Androgenetic Alopecia: A Randomized Clinical Trial.

Oral Minoxidil vs Topical Minoxidil for Male Androgenetic Alopecia

Papers