Clinical Research Directory

Clinical Study of DA-002 and DA-005 as a Treatment for Hair Loss

The primary objective of the study is to assess the safety and efficacy of DA-005 and DA-002 as a treatment for hair loss (androgenetic alopecia).

Evaluation of Efficacy and Safety of Oral Minoxidil 1 mg in Female Androgenetic Alopecia

This phase III clinical trial is evaluating whether oral minoxidil 1 mg is an effective and safe treatment for women with androgenetic alopecia (female pattern hair loss). Approximately 520 women is planned to take part in the study. Participants will be randomly assigned to receive either oral minoxidil, topical minoxidil 2% solution, or placebo. Neither the participants nor the study staff will know which treatment has been assigned. The study will last up to 36 weeks, including a treatment period of 24 weeks and a follow-up period. Participants will attend regular study visits to assess hair growth and monitor safety. Site investigators will evaluate changes in hair growth and hair density using scalp imaging, investigator assessments, and participant questionnaires. Safety will be monitored through physical examinations, vital signs, laboratory tests, electrocardiograms, and the recording of side effects throughout the study.

Phase 2 Efficacy and Safety of PP405 in Adult Females With Androgenetic Alopecia

The study is designed to evaluate safety and efficacy of PP405 in adult female participants with androgenetic alopecia

Phase 2/3 Efficacy and Safety of PP405 in Adult Males

The study is designed to validate efficacy and long term safety of PP405.

Efficacy and Safety of CosmeRNA-ARI Anti Hair Loss Tonic in Adults With Androgenetic Alopecia

This study evaluated the efficacy and safety of two concentrations of CosmeRNA-ARI Anti Hair Loss Tonic in adults with androgenetic alopecia. Participants were randomly assigned to receive the low-concentration investigational product, the high-concentration investigational product, or a vehicle control product without the active ingredient. Each assigned product was applied to the scalp once every 2 weeks for 24 weeks. Hair density, hair thickness, hair growth rate, expert-assessed changes in hair density, participant-reported outcomes, and scalp safety were evaluated. The study was designed to determine whether the investigational products improved hair growth-related outcomes compared with the vehicle control product.

A Split-Scalp Study Evaluating the Efficacy and Safety of Fractional Laser Therapy With and Without Exosomes in the Treatment of Androgenetic Alopecia

This trial aims to evaluate the efficacy, safety, and tolerability of fractional laser combined with topical exosome for hair regrowth in patients with androgenetic alopecia. This study is expected to recruit 30 participants. The experimental group will receive fractional laser treatment combined with human umbilical cord mesenchymal stem cell exosome solution; the control group will receive fractional laser treatment combined with a placebo. Participants will receive three fractional laser treatments and will be followed up for 6 months. At each follow-up visit, hair density, diameter, vellus hair to terminal hair ratio, and adverse reactions will be assessed using trichotomy; a global photographic assessment will be performed using standardized imaging equipment.

Safety, Pharmacokinetics and Efficacy of PP405 in Adults With AGA

The study is a two part study, designed to validate safety results from the Phase 1 PP405-001 trial while also characterizing longer term safety and PK. Part 1 of the trial is the randomized controlled portion that will focus on safety and PK following 28 days of blinded treatment administration with either PP405 or vehicle control. Part 2 of the trial is an open-label extension that will validate the results of Part 1 with 3 months of treatment administration.

A Study of the Safety, Tolerability, and Efficacy of Topical SM04554 Solution in Male Subjects With Androgenetic Alopecia (AGA)

The purpose of this study is to characterize the safety, tolerability, and efficacy of topical SM04554 solution (0.15% and 0.25%) applied to the scalp of male subjects with Androgenetic Alopecia (AGA).

Efficacy of Botulinum Toxin A Versus Nanofat in the Treatment of Androgenetic Alopecia: A Comparative Clinical Trial

The goal of this clinical trial is to learn whether botulinum toxin A (BTA) or autologous nanofat injection is more effective for treating male androgenetic alopecia. It will also assess the safety of both treatments. The main questions it aims to answer are: * Does botulinum toxin A or nanofat produce a greater increase in total hair count after 6 months? * How do the treatments affect terminal hairs, vellus hairs, hair shaft characteristics, and other dermoscopic features? * What side effects occur with each treatment? * How satisfied are participants with the improvement in their hair condition? Researchers will compare intramuscular botulinum toxin A injections with intradermal autologous nanofat injections in men aged 18 to 40 years with Norwood Hamilton grade II or III androgenetic alopecia. Participants will: * Be randomly assigned to receive either botulinum toxin A or nanofat * Receive one treatment session at the beginning of the study * Have clinical, dermoscopic, and photographic assessments at baseline, 3 months, and 6 months * Have changes in total hair count and other hair characteristics measured during follow-up * Report any treatment-related side effects and their satisfaction with the result

A Study of SM04554 Applied Topically to the Scalp of Male Subjects With Androgenetic Alopecia Analyzed by Biopsy of the Scalp Prior To and Post Dosing

This study will assess the safety, tolerability, and efficacy of SM04554 at concentrations of 0.15% and 0.25%. Improved knowledge of the changes in hair counts and immunohistochemical analysis associated with androgenetic alopecia (AGA) before and after treatment with SM04554 and compared to placebo may lead to a greater understanding of the underlying mechanisms of action of SM04554.

A Study Evaluating the Efficacy and Safety of SM04554 Topical Solution in Male Subjects With Androgenetic Alopecia

This multi-center, randomized, double-blind, placebo-controlled study, conducted in Turkey, will assess the efficacy and safety of topical SM04554 solution (0.15% and 0.25%) applied daily to the scalp of male androgenetic alopecia (AGA) subjects.

1470nm Laser for the Treatment of Androgenetic Alopecia and Scarring Alopecia

Single-center, open-label, baseline-controlled, pilot study evaluating the use of a Nonablative 1470 nm laser for the treatment of androgenetic alopecia and scarring alopecia.

Evidence-Based Integrated Protocol to Maximize Hair Follicle Survival in Follicular Unit Extraction (FUE)

Follicular unit extraction (FUE) is a widely used surgical technique for hair restoration, yet hair follicle survival rates vary depending on surgical instrumentation, graft handling, and perioperative care. The purpose of this clinical trial is to evaluate whether an evidence-based, integrated perioperative protocol maximizes hair follicle graft survival compared with standard departmental practice in male patients undergoing FUE for androgenetic alopecia or localized scarring alopecia. Participants will be randomly assigned to one of two groups: * Integrated Protocol Group: Patients receive FUE surgery guided by a standardized workflow featuring algorithmic punch selection (0.8-1.0 mm), pre-set extraction depth and angulation, chilled holding solutions maintained at 4 °C, strict graft out-of-body time limits (target ≤2-4 hours), and standardized recipient site implantation. * Standard FUE Practice Group: Patients receive FUE surgery according to routine departmental practice, where punch selection, harvesting parameters, and graft handling follow the operating surgeon's standard routine. Follicle survival and hair density will be tracked using digital trichoscopy in pre-marked 1×1 cm reference scalp areas over a 12-month follow-up period. Investigators will also assess intraoperative follicular transection rates, procedural complications, and patient satisfaction between the two groups.

Topical Rifamycin SV for Wound Healing After Sapphire FUE Hair Transplantation

This prospective, parallel-group controlled clinical study evaluated whether a single topical rifamycin SV protocol added to standardized care after sapphire follicular unit extraction (FUE) was associated with earlier recorded wound healing. One hundred candidates were assessed, and 70 men were individually allocated 1:1 using MedCalc. Five participants were excluded after allocation but before surgery and before receiving the assigned intervention because final preoperative serological testing met prespecified exclusion criteria. The analyzed sample comprised 34 participants in the rifamycin SV group and 31 in the control group. Healing was assessed through postoperative Day 14 using scheduled clinical review and serial photographs. Infection and hypersensitivity were monitored as safety outcomes.

A Phase 3 Study to Evaluate the Safety and Efficacy of CKD-843 in Male Patients With Androgenetic Alopecia

This is a multi-centers, randomized, double-blind, parallel-group, Phase 3 Trial to evaluate the efficacy and safety of CKD-843 in Male patients with Androgenetic Alopecia

Exosome Injection Versus Topical Minoxidil for Androgenetic Alopecia

Androgenetic alopecia (AGA) is a common form of hair loss characterized by progressive hair follicle miniaturization. This prospective randomized comparative study evaluates the efficacy and safety of intradermal exosome injections compared with 5% topical minoxidil in patients with AGA. Forty patients were randomly assigned to receive either intradermal exosome injections or topical minoxidil for three months, with clinical, trichoscopic, patient-reported, and safety outcomes assessed at baseline, after treatment, and at 3-month follow-up.

Safety and Efficacy of VDPHL01 in Females With Androgenetic Alopecia (AGA)

This study will evaluate the safety and efficacy of VDPHL01 in female subjects with Androgenetic Alopecia (AGA). AGA is a genetic disorder caused by an excessive (too much) hair follicle response to androgens (hormones) that causes hair loss. VDPHL01 is an investigational oral drug to treat AGA. This multi-center, double blind, study will last about 13 months and includes 11 study visits (screening, baseline (day 1), week 2, month 1, month 2, month 4, month 6, month 8, month 10, month 12, month 13).

XVIE to Treat Androgenetic Alopecia (AGA)

This study tests whether XVIE, an investigational injectable product made from processed human amniotic fluid, is safe and may help regrow hair in adults with androgenetic alopecia (common pattern hair loss). XVIE contains growth factors and extracellular vesicles that may stimulate hair follicle activity. Thirty participants will be randomly assigned to receive either XVIE or a saline placebo injected into the scalp in two treatment sessions, 90 days apart. Neither participants nor study staff will know which treatment is being given. Participants will be followed for 6 months. The main goal is to evaluate safety. A secondary goal is to assess whether hair count, density, or coverage improves.

A Study on the Efficacy and Safety of Microneedling for Male Androgenetic Alopecia

Androgenetic alopecia (AGA) is the most prevalent hair-loss disorder in clinical practice. With a high incidence rate, it not only severely impairs patients' appearance and quality of life, but may also trigger varying degrees of depression and compromise mental health, highlighting the critical importance of standardized management for AGA. Current therapeutic options for AGA include oral finasteride, topical minoxidil, physical therapies and others. Nevertheless, safety concerns over oral medications remain prominent. Finasteride, a first-line agent, is associated with adverse reactions such as decreased libido, erectile dysfunction and reduced ejaculate volume, which limits patient acceptance. In recent years, microneedling for AGA has attracted attention, clinical adoption and recognition among dermatologists, demonstrating favorable safety profiles and promising therapeutic outcomes in real-world clinical practice. Minoxidil is an effective hair-growth-promoting drug. Topical 2% or 5% minoxidil exhibits satisfactory efficacy and safety for AGA and is frequently combined with other interventions to enhance treatment benefits. Microneedling combined with topical minoxidil represents a commonly-used regimen for AGA in clinical settings. However, substantial heterogeneity exists regarding microneedling parameters including needle depth, treatment frequency and total treatment duration across medical institutions and clinical studies. Needle depth is closely correlated with patient perception, therapeutic efficacy and adverse events such as bleeding; treatment frequency is strongly linked to patient compliance and clinical outcomes. Despite the widespread clinical use of microneedling, standardized treatment protocols are still lacking, which greatly undermines the standardization, treatment efficacy and patient compliance of physical therapy for androgenetic alopecia. This study plans to enroll 190 male patients with AGA. Participants will be stratified into different groups according to microneedling depth and treatment frequency, and receive standardized intervention for 24 weeks. The primary objective is to explore the optimal microneedling regimen (including needle depth and treatment frequency). We will also evaluate how disease course, hair-loss classification and severity grading influence therapeutic efficacy and safety among AGA patients. Findings from this trial will provide evidence-based references for dermatologists to deliver precise and individualized AGA care, support the development of clinical guidelines, and facilitate standardized clinical implementation of this combination therapy.

Comparing Standard Platelet-Rich Plasma and Light-Enhanced Platelet-Rich Plasma for Treating Hair Loss in Androgenetic Alopecia: A Randomized Controlled Trial

The goal of this clinical trial is to compare 3 different types of PRP in androgenetic alopecia patients. The main questions it aims to answer: Does Redlight enhanced, Blue light enhanced, or traditional PRP result in higher hair density and health? Does Redlight enhanced, Blue light enhanced, or traditional PRP result in other improved hair metrics. Participants will consent to a PRP treatment but will be blinded to the type. They will then be asked to return for Tricholab analysis at set post-operative timepoints to record changes in hair metrics (Baseline, 1 month, 3 months, 6 months, 9 months, 12 months).

THERAVEX® REGENERA Tissue Care Plus for Hair Regeneration and Follicular Microenvironment Modulation

To evaluate the safety and clinical performance of THERAVEX® REGENERA Tissue Care Plus as an adjunctive regenerative support therapy in patients undergoing hair restoration procedures and regenerative scalp treatment protocols. This clinical investigation assessed the use of a bioactive mineral-ionic formulation during follicular graft preparation, postoperative scalp care, and regenerative scalp support applications in participants presenting with hair loss and follicular density reduction. Clinical follow-up evaluations included assessment of scalp tissue response, postoperative recovery, follicular density changes, tolerability, and longitudinal photographic documentation under standardized clinical conditions. The study also explored the feasibility of supportive regenerative scalp procedures including Dermapen-assisted and mesotherapy-assisted scalp applications.

Study of EPI-001 in Patients With Androgenetic Alopecia

This is a Phase I/IIa clinical study to evaluate the safety, tolerability, and preliminary efficacy of EPI-001 in patients with androgenetic alopecia. In the Phase I portion, a traditional 3+3 dose-escalation design will be used to determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of EPI-001. Subjects will be followed for up to 24 weeks after administration. In the Phase IIa portion, subjects will be randomized in a 2:1 ratio to receive either EPI-001 or placebo. Safety and efficacy will be evaluated through hair count assessment, hair diameter measurement, clinical photography, investigator assessment, expert panel assessment, and subject self-assessment during a follow-up period of up to 48 weeks.

Efficacy & Safety of Minoxidil SL Tablets in Men With AGA

This is a phase 3, multicentre, randomised, double-blinded, placebo-controlled study examining the safety and efficacy of 2.5 mg sublingual (SL) minoxidil tablets taken twice daily in the treatment of androgenetic alopecia (AGA) in men. The duration of study participation is 32 weeks including screening and safety follow up. The primary efficacy objective is to determine whether treatment with 2.5 mg SL tablets twice daily increases the number of hairs in men with AGA over 24 weeks. The primary safety objective is to evaluate the safety and tolerability of 2.5 mg SL tablets administered twice daily over 24 weeks.

JAK2 Expression in Androgenetic Alopecia Before and After Topical Minoxidil

Androgenetic alopecia is a common form of progressive hair loss. This prospective single-arm pre-post interventional study aims to assess tissue Janus Kinase 2 (JAK2) expression in patients with androgenetic alopecia by comparing balding and non-balding scalp at baseline, and to evaluate changes in JAK2 expression in balding scalp after 3 months of topical minoxidil 5% therapy. Clinical response will be assessed using standardized trichoscopic parameters.