Alopecia Dermatitis, Seborrheic
Conditions
Interventions
Single arm (intervention): dietary supplement based on pumpkin seed oil combined with a probiotic, an amino acid, vitamins, and minerals, presented as 1 capsule and 1 tablet, administered orally and c
Sponsors
Divcom S/A
Medcin Pesquisa Clínica LTDA
Bioma Genetics
Eligibility
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: Participants of both sexes; aged 18 to 55 years; with an equal distribution of females (50%) and males (50%); diagnosis of androgenetic alopecia classified as grade II to IV in men according to the Hamilton–Norwood scale and grade I to II in women according to the Ludwig scale, with at least 20 participants presenting a documented medical history of seborrheic dermatitis of the scalp; intact scalp in the product evaluation area; agreement to refrain from the use of hair loss treatments, including laser therapy, intradermal drug delivery techniques, microneedling, or other similar interventions, throughout the study period; availability to undergo blood collection and scalp swab collection when required
Exclusion criteria
Exclusion criteria: Pregnancy or lactation; use of anti-inflammatory, immunosuppressive, or antihistamine drugs within three weeks prior to selection; presence of cutaneous marks in the evaluation area that may interfere with the analysis, including vascular malformations, scars, increased hair growth, multiple nevi, or sunburn; history of allergy to any component of the product formulation; presence of active dermatological conditions and/or skin lesions in the evaluation area, except for seborrheic dermatitis; hair growth treatment within the previous six months; immunosuppression due to medication use or active disease within the previous six months; presence of uncontrolled endocrinopathies; clinically relevant history or current evidence of abuse of alcohol, tobacco, or other substances; known history or suspected intolerance to products of the same category; intense sun exposure within fifteen days prior to evaluation; previous hair transplantation; use of oral treatment or supplementation for hair disorders within the previous six months; use of medications or supplements intended for hair loss, hair growth, hair strengthening, dandruff control, or oiliness control during the study period
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluate the variation in terminal hair density (number of terminal hairs per cm²), measured by phototrichogram, after 180 days of dietary supplement use, compared with baseline, in adults with androgenetic alopecia | — |
Secondary
| Measure | Time frame |
|---|---|
| Variation in the proportion of terminal hairs relative to vellus hairs (terminal/vellus ratio), assessed by phototrichogram, after 45, 90, 135, and 180 days of dietary supplement use, compared with baseline;Variation in mean hair shaft thickness (µm), measured by phototrichogram, after 45, 90, 135, and 180 days of dietary supplement use, compared with baseline;Variation in the absolute count of terminal hairs and total hairs, assessed by phototrichogram, after 45, 90, 135, and 180 days of dietary supplement use, compared with baseline;Variation in terminal and total hair density (number of hairs per cm²), measured by phototrichogram, after 45, 90, 135, and 180 days of dietary supplement use, compared with baseline;Variation in scalp oiliness, measured by an instrumental method (Sebumeter®), after 45, 90, 135, and 180 days of dietary supplement use, compared with baseline;Occurrence of adverse events and participant-reported discomfort, assessed under real-world conditions after 45, 90, 135, and 180 days of product use;Variation in clinical scalp parameters, assessed by dermatological examination using a 5-point ordinal scale, after 45, 90, 135, and 180 days of dietary supplement use, compared with baseline ;Variation in participant-perceived efficacy, assessed using a structured self-perception questionnaire, after 45, 90, 135, and 180 days of continuous dietary supplement use;Variation in systemic hormonal parameters (free testosterone, dihydrotestosterone, and dehydroepiandrosterone sulfate), assessed by blood collection at baseline and after 180 days of dietary supplement use, in a subgroup of 20 male participants;Variation in scalp microbiota composition across frontal, occipital, and temporal regions assessed by amplicon metagenomics (16S rRNA and ITS), from baseline to 180 days of dietary supplement use | — |
Countries
BR
Contacts
Public ContactFernanda Bayan
Divcom S/A
Outcome results
None listed