Clinical Research Directory

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.

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.

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

The goal of this clinical trial is to learn about oral minoxidil 1mg in the treatment of women with androgenetic alopecia, a type of hormone-imbalanced hair loss. The main questions to answer are to know about that minoxidil 1mg is as effective as minoxidil 2% topical solution (comparator product) and is more effective than placebo; and to ensure treatment with oral minoxidil is safe. Participants will be assigned randomly to receive one of the following treatment combinations: * the test product (oral minoxidil 1 mg, once/day) and the vehicle solution (vehicle means it looks like the comparator product, but it does not contain an active ingredient, 2 times/day), or * the placebo tablet (placebo means it looks like the test product, but it does not contain an active ingredient, once/day) and the comparator product (2% minoxidil solution, 2 times/day), or * the placebo tablet (once/day) and the vehicle solution (2 times/day). The clinical trial will take up to 36 weeks. During this time, patients will come to the clinical trial centre for 5 times for examinations and will be called by phone twice. At the visits, the following examinations will be performed: photos of the hair will be taken to determine hair density, assessment of changes in scalp hair growth, measurement of blood pressure, pulse, and body temperature, a physical examination, blood withdrawal to determine any abnormalities in the blood, urine sampling and analysis, performance of ECG, and evaluation of hypertrichosis (i.e., excessive hair growth over the body). Furthermore, patients will be asked daily whether they had experienced any side effects or took any new medications (or changed the dose of a known medication) or underwent any medical procedure. Also, women of childbearing potential must undergo pregnancy tests in blood and urine.

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.

Phase 3 Study to Evaluate the Efficacy and Safety of Oral Minoxidil (N1087) in Men With Androgenetic Alopecia.

This study is a Phase 3 clinical trial designed to evaluate the efficacy and safety of N1087 compared with placebo in adult men with androgenetic alopecia (male pattern hair loss). The study will include male participants aged 18 to 60 years who have a clinical diagnosis of androgenetic alopecia classified as stages 3V, 4, or 5 on the Norwood-Hamilton scale. Participants will be randomly assigned, in a 2:1 ratio, to receive either N1087 or placebo. Neither the participants nor the study team will know which treatment each participant receives. The study treatment will be taken orally once daily for a total of 24 weeks. During the first 8 weeks, the dose will be gradually increased (titration period) up to a maximum tolerated dose, not exceeding 5 mg. Participants will then continue treatment at the maximum tolerated dose for the remaining 16 weeks. The main purpose of the study is to assess whether oral minoxidil improves hair growth. The primary outcome measure is the change from baseline in the density of non-vellus hairs in a defined target area of the scalp (vertex) after 24 weeks of treatment, measured using digital phototrichogram analysis. Secondary objectives include evaluating changes in hair density at earlier time points, hair thickness, the proportion of terminal hairs, clinical improvement assessed by the investigator, quality of life related to hair loss, and participant satisfaction with treatment. The safety and tolerability of oral minoxidil will also be evaluated by monitoring adverse events, vital signs, and events of special interest throughout the study. An independent Data and Safety Monitoring Committee will oversee participant safety during the trial. This is a multicenter study conducted in Brazil, with approximately 372 participants expected to be enrolled.

Clinical Study of DA-001 as a Treatment for Hair Shedding Reduction and Hair Re-Growth

The primary objective of the study is to assess the safety and efficacy of DA-001 as a treatment for Hair Shedding Reduction and Hair Re-Growth

The Effect of Nanofat Injection on Androgenetic Alopecia

Androgenetic alopecia is a condition that bothers a lot of people. The disadvantage of the FDA approved topical minoxidil is that the patient needs to be compliant every day for extended periods of time. This is the main reason why this study is being conducted, to see if a single nanofat injection is superior to applying either topical Minoxidil or PRP

Assessment of Dutasteride Topical Solution in Male Androgenetic Alopecia

This is a randomized, open-label phase 1/2a study designed to evaluate the pharmacokinetics, pharmacodynamics, and safety of AD-303A (topical formulation) and AD-3031 in male patients with androgenetic alopecia. The study aims to compare pharmacological characteristics and safety profiles to support dose selection for further clinical development.

Harnessing Artificial Intelligence for Diagnosing Androgenetic Alopecia: A Training and Validation Study

The aim of this study is to develop and validate deep learning models in diagnosis of male and female pattern hair loss, and assessment of its severity based on clinical and trichoscopic image by handheld dermoscopy and administrative data (age and sex).

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.

Efficacy and Safety of 5% Minoxidil Foam in Female Androgenetic Alopecia

The primary objective of this study is to evaluate the efficacy of once-daily 5% minoxidil foam versus placebo in female androgenetic alopecia, using the Target Area Terminal Hair Count (TAHC) as the primary endpoint.

Secretome vs. PRP Injections for Hair Density and Growth in Androgenetic Alopecia Patients

This study aims to compare the effectiveness of secretome injection and intradermal platelet-rich plasma (PRP) injection on hair density and the terminal-to-vellus hair ratio in patients with androgenetic alopecia at Prof. Dr. I.G.N.G. Ngoerah General Hospital.

Safety and Efficacy of VDPHL01 in Males With AGA

This study will evaluate the safety and efficacy of VDPHL01 in male subjects with Androgenetic Alopecia (AGA). AGA (or male pattern baldness) is a genetic disorder caused by an excessive (too much) hair follicle response to androgens (hormone) that causes hair loss. VDPHL01 8.5 mg Tablet is an investigational oral drug to treat male pattern baldness. 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).

Efficacy and Safety of Finlândia Hair Lotion Association on Androgenetic Alopecia

The purpose of this study is to evaluate the efficacy of Finlândia hair lotion association in the treatment of androgenetic alopecia.

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 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).

Safety and Efficacy of VDPHL01 in Males and Females With AGA

This study will evaluate the safety and efficacy of VDPHL01 in male and female subjects with Androgenetic Alopecia (AGA). AGA (or pattern of hair loss) is a genetic disorder caused by an excessive (too much) hair follicle response to androgens (hormone) that causes hair loss. VDPHL01 8.5 mg Tablets for males and VDPHL01 4.5 mg Tablets for females are an investigational oral drug to treat male and female pattern baldness. This multiple center, open-label, 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). Male subjects that meet the study eligibility criteria will be administered VDPHL01 once daily for 12 months. Female subjects that meet the study eligibility criteria will be administered VDPHL01 either once or twice daily for 12 months.

Efficacy and Safety of VDPHL01 in Males With AGA

This study will evaluate the safety and efficacy of VDPHL01 in male subjects with Androgenetic Alopecia (AGA). AGA (or male pattern baldness) is a genetic disorder caused by an excessive (too much) hair follicle response to androgens (hormone) that causes hair loss. VDPHL01 8.5 mg Tablet is an investigational oral drug to treat male pattern baldness. 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). The first 7 visits will be part of the placebo-controlled period. The next 3 visits will be part of the treatment extension phase. All subjects will receive active drug in the treatment extension phase.

Evaluation of Exosomes Injection in Treatment of Male Androgenetic Alopecia: Clinical and Immunohistochemical Study

Intradermal injection of exosomes in treatment of male androgenetic alopecia, clinically and using a immunohistochemical marker

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.

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

Six-Month Single-Blind, Placebo-Controlled Study of a Dietary Supplement Supplement on Hair Growth in 45 Volunteers

This clinical study is designed to evaluate the efficacy and safety of a dietary supplement CL-P24113a for the management of androgenetic alopecia (AGA) in male subjects aged 18 to 45 years who suffer from alopecia with low hair density, classified as mild to moderate (Hamilton-Norwood stages II, III, and IV). The product is a formulation based on a blend of botanical ingredients and other well-established compounds, including Pumpkin Seed Oil (Curcubita pepo), Saw Palmetto Oil (Serenoa repens), L-Cystine, Prunus africana Bark Extract (Pygeum africanum), Horsetail Extract (Equisetum arvense), Olive Leaf Extract, among other excipients. These components have a well-documented history of safe use in both topical and oral applications with supporting safety information from international bodies such as EFSA. In this instrumental, single-blind, placebo-controlled study, 45 volunteers will be divided into two groups, with 30 subjects receiving the supplement and 15 subjects receiving a placebo. All participants will ingest one capsule per day, preferably in the morning with a glass of water, over a 6-month treatment period. Prior to study initiation, subjects must complete a 30-day washout period using a neutral shampoo and agree not to apply any other topical or oral hair treatments in the target area throughout the study. The study will evaluate efficacy through both instrumental and subjective assessments. Instrumental evaluations will be conducted at 3 and 6 months using the TrichoScan HD Professional 4.0 system to measure hair growth parameters such as total hair count, hair density per cm², proportion of hairs, terminal hair count and density, proportion of terminal hairs, as well as the percentages of anagen and telogen hairs. Additionally, measurements of hair thickness including hair mass per cm², median and mean hair thickness in micrometers, overall scalp hair density, and median hair length will be recorded. Subjective evaluations will be performed via questionnaires administered at 1.5, 3, 4.5, and 6 months to capture participants' perceptions regarding hair growth and hair loss. The study is overseen by Principal Investigator at Dermaclaim Lab S.L. Regulatory compliance will be ensured by obtaining written informed consent for both study participation and data protection, and all subjects will be thoroughly briefed on study requirements and potential risks. This study aims to provide robust clinical evidence on the effectiveness of the oral supplement in promoting hair growth and reducing hair loss in men affected by androgenetic alopecia, potentially offering a safe and well-tolerated alternative to existing hair loss therapies while ensuring continuous monitoring for any adverse events throughout the treatment period.

Various Procedural Treatment Options for Androgenetic Alopecia

Androgenetic alopecia (AGA)is the most common form of alopecia. It predominantly affects males, but there has been a significant surge in female preponderance too, over the last decade Minoxidil belong to the anti-hypertensive class but it also affects the potassium channels present in vascular smooth muscles and hair follicles. This potassium channel activity may stimulate the microcirculation around the hair follicles and induces arteriolar vasodilation, thereby encouraging conditions conducive to hair growth Topical administration of finasteride offers the potential to reduce systemic effects related to its mechanism of action by preferentially inhibiting 5-a reductase in the scalp, as has been suggested in recent years so in this study we are going to compare efficacy of topical minoxidil versus topical finasteride in treatment of androgenetic alopecia

The Effectiveness of Allogenic Mesenchymal Stem Cells Therapy on Hair Regrowth in Androgenetic Alopecia.

The goal of this study is to learn if mesenchymal stem cell therapy (treatment group) can effectively treat adrogenic alopecia or male-pattern baldness, when compared to normal saline (given to placebo group). It will also assess the differences in patient satisfaction. The main focus will be to: 1. Compare the average hair regenerative effect of mesenchymal stem cells versus Placebo, in treatment of androgenetic alopecia. 2. To determine and compare the investigators assessment and patient satisfaction in both groups. Patients in treatment group will receive single session of MSC therapy injected in the scalp and placebo group will receive 0.9% saline solution. The participants will be followed for 12 weeks. The hair density and thickness will be mesured along with clinicians assessment and participant's satisfaction level.