Brittle Nail Syndrome
Conditions
Interventions
Group 1: Pycnogenol, 150 mg per day over 24 weeks
Group 2: Placebo control group
Sponsors
IUF - Leibniz-Institut für umweltmed. Forschung GmbH
Eligibility
Sex/Gender
All
Age
20 Years to 65 Years
Inclusion criteria
Inclusion criteria: ? Women must agree to a pregnancy test being carried out at the start of the study participation; ? Signs of brittle and weakened nails on at least one finger (Only subjects with signs of brittle nails on their fingers are included. The moist ‘climate’ in footwear predisposes to fungal nail infections, which cannot always be clinically distinguished from primary (idiopathic) brittle nail syndrome); ? Age 20-65 years, both inclusive; ? Healthy with no clinically significant abnormality identified by medical history and clinical examination, in particular no evidence of underlying diseases responsible for brittle nails (diabetes, cancer, renal, pulmonary, cardiac, hepatic, neurological, inflammatory or immunosuppressive diseases); ? Must agree not to use dietary supplements (e.g., herbal, vitamin (C, E, B6, biotin), minerals (zinc, magnesium, iron, copper), amino acids) from the beginning of the study at the screening visit and throughout the study; ? Must agree not to change their dietary habits and to avoid changes to detergents or household cleaning products likely to come into contact with hands/nails for the duration of the study; ? Compliant to follow the study protocol and the instructions of the investigator throughout the study;
Exclusion criteria
Exclusion criteria: ? Application of topical preparations and care products (incl. nail polish) to the test areas 28 days before and during the treatment phase of the study; ? Pregnant or lactating women; ? Female participants of childbearing potential who are not willing or able to use a highly effective method of contraception (e.g., hormonal contraception, intrauterine device, intrauterine hormone-releasing system, bilateral tubal occlusion) during the study period; ? Skin disease such as eczema, psoriasis, lichen ruber, lichen striatus, alopecia areata; ? Members of professional groups (such as hairdressers, cleaners, etc.) whose nails are constantly exposed to external stressors such as prolonged contact with water, microtraumas, chemicals and other irritants (as these would confound the study due to the inability to eliminate the underlying cause of brittle nails); ? Known vitamin deficiency or deficiency of trace elements and iron; ? Known allergy or intolerance (if possible documented in allergy pass card) to any component of the test preparations or other products administered during the study; ? History of malignancy not curatively treated at least 5 years before screening visit with exception of basal cell carcinoma which may have been curatively treated within 1 year; ? Any systemic or topical medication, including herbal supplements, within 14 days before participating in the study, apart from paracetamol; ? Subjects following any special diet including, but not limited to liquid, high or low protein, raw food, vegetarian or vegan, etc. (as these lifestyles predispose to vitamin and nutrient deficiencies if no additional supplementation is available); ? Participants with a current or past diagnosis of an eating disorder (e.g., anorexia nervosa, bulimia nervosa); ? Alcohol consumption of more than one unit of hard spirits/day ? History or current use of illegal or “recreational” drugs; ? Individuals diagnosed with communicable diseases (e.g., hepatitis, HIV, Covid-19, Mpox) ? Participation in a clinical research trial within 30 days prior to randomization; ? Unable to understand and comply with protocol requirements and timetables, instructions and protocol-stated restrictions; ? Any condition which, in the opinion of the investigator, might put the subject at risk by participating in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in clinical signs of brittle nails and nail growth rate from baseline to week 12 and week 24 (assessed by study personnel) | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in nail thickness, transonychial water loss, nail glow, nail surface roughness, clinical signs of nail health (assessed via participant questionnaire), and frequency of cracked nail (diary) from baseline to week 12 and week 24 | — |
Countries
Germany
Contacts
Public ContactNatalie Aue
IUF - Leibniz-Institut für umweltmed. Forschung GmbH
Outcome results
None listed