Evaluation of the Dietary Supplement Effect on Improvement of Hair Condition in Subjects With Occasional Hair Loss.
Prospective, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Tolerability of an Oral Dietary Supplement for Occasional Telogen Effluvium in Adult Men and Women.
The goal of this study is to learn if dietary supplement works to help with improving hair condition in subjects with occasional hair loss. It will also learn about its safety. The main question it aims to answer is:
• Does the dietary supplement reduce the number of hair lost by participants? Researchers will compare dietary supplement to a placebo (a look-alike substance that contains no drug) to see if it works to reduce hair loss.
Participants will:
- Take dietary supplement or a placebo every day for 3 months
- Visit the clinic every month for evaluations
Studieoversikt
Status
Status
Forhold
Forhold
Intervensjon / Behandling
Intervensjon / Behandling
Studietype
Studietype
Registrering (Antatt)
Registrering
Fase
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
Studiekontakt
- Navn: Chávez Bourgeois, Dr.
- Telefonnummer: +34 937 37 64 00
- E-post: marionminisa@gmail.com
Studiesteder
-
-
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Barcelona, Spania
- Cosmocare
-
Ta kontakt med:
- Fernández Botello
- Telefonnummer: +34 937 37 64 00
- E-post: alfonsofernandez@cosmocare.eu
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Men and women aged 18 to 70 years.
- Self-perceived occasional telogen effluvium, with a count of 100 or more shed hairs in the standardized wash and combing test, confirmed at the screening visit (Visit 0), of recent onset (less than 6 months) and attributable to factors such as stress, nutritional deficiency, pollution, or seasonality.
- Good general health, in the investigator's judgment, with no relevant uncontrolled systemic disease.
- Availability and willingness to attend the three study visits and comply with study procedures over a 90-day period.
- Agreement to receive study-related communications electronically (email and/or SMS), where expressly authorized.
- Ability to understand the study and provide written informed consent.
Exclusion Criteria:
-
Refusal to provide informed consent to participate in the study.
- Inability to understand the study language.
- Pregnancy or breastfeeding.
- Established androgenetic alopecia (Hamilton-Norwood classification or other pattern hair loss disorders) or other forms of alopecia (alopecia areata, scarring alopecia, trichotillomania, or others) diagnosed or suspected by the investigator.
- Use of specific pharmacological or cosmetic treatments for hair loss (minoxidil, finasteride, topical or systemic corticosteroids, other dietary supplements, or hair lotions) within the 3 months prior to enrollment.
- Uncontrolled endocrine disease (e.g., thyroid disorders), diagnosed severe nutritional deficiency, untreated anemia, or a recent history (< 6 months) of severe febrile illness, major surgery, or childbirth.
- Active scalp dermatological conditions (psoriasis, moderate-to-severe seborrheic dermatitis, fungal or bacterial infections) that may interfere with clinical assessment or instrumental evaluation techniques.
- Any disease, treatment, or characteristic that, in the investigator's opinion, may preclude participation due to unnecessary risk or interference with the study and/or interpretation of the results, particularly:
- Use of aspirin or related compounds, antibiotics, anti-inflammatory drugs, corticosteroids, antidepressants, antihistamines, or immunosuppressive treatments.
- Ongoing allergen desensitization therapy (allergy immunotherapy).
- Presence of dermatological abnormalities in the study area, such as irritation, erythema, scars, pigmentation disorders, numerous freckles, or nevi.
- History of intolerance or allergy to medications or other substances that may pose an unjustified risk.
- Use of a nutricosmetic supplement within the 3 months prior to study initiation or during the entire study period.
- History of intolerance or allergy to cosmetic products of the same type as the investigational product.
- Receipt of a vaccination within the previous month or planned vaccination during the study period.
- Surgical intervention in the study area within the month prior to study initiation or during the study.
- Undergoing aesthetic procedures that may affect the scalp during the study, such as oxidative root hair coloring, perming, Japanese straightening, keratin straightening, or full hair bleaching (color rinses, temporary dyes, highlights, light hairstyling, and salon styling procedures are permitted).
- Combing, washing, or dyeing the hair within the 48 hours preceding a study visit.
- Simultaneous participation in other studies related to the same therapeutic or application area.
- Modification of cosmetic habits in the study area within the 15 days prior to study initiation.
Exposure to intense sunlight or ultraviolet (UV) radiation within the month prior to study enrollment, or anticipated exposure during the study period.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Annen
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Trippel
Antall våpen
Våpen og intervensjoner
Deltakergruppe / ArmDeltakergruppe / Arm |
Intervensjon / BehandlingIntervensjon / Behandling |
|---|---|
|
Placebo komparator: Placebo kapsel
|
Placebo will be taken daily for 2 months |
|
Eksperimentell: Dietary supplement capsule
|
Dietary supplement will be taken daily for 2 months |
Hva måler studien?
Primære resultatmål
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change from Baseline in the number of shed hairs at 3 Months
Tidsramme: From enrollment to the end of treatment at 3 months
|
Hair loss will be evaluated by wash and combing test |
From enrollment to the end of treatment at 3 months
|
Samarbeidspartnere og etterforskere
Sponsor
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Studiestart
Primær fullføring (Antatt)
Primær fullføring
Studiet fullført (Antatt)
Studiet fullført
Datoer for studieregistrering
Først innsendt
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Først lagt ut
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Sist oppdatering lagt ut
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
Andre studie-ID-numre
- CT26786
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
Only data included in the publication will be shared.
Legemiddel- og utstyrsinformasjon, studiedokumenter
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