Clinical trials

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.

The goal of this pilot study is to learn about the effect of the nutritional supplementation based on AM3 in combination with probiotics on imflammatory and metabolic mediators in adult subjects diagnosed with metabolic syndrome. The hypothesis the investigators are testing focuses on the fact that the continued use of the nutritional supplement with AM3 and probiotics is capable of minimizing the risk factors associated with metabolic syndrome, by reducing the development of the derived chronic pathologies. A total of 48 subjects with a diagnosis of metabolic syndrome is planned to be recruited from two investigational sites in the Comunity of Madrid (Spain). These subjects will be randomized into three treatment groups (active, placebo, and control). The dosage will be of 2 capsules/day in a single intake in the morning for 12 weeks. Two interventional visits are planned to be performed: at baseline and at week 12.

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.