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
Descripción general del estudio
Estado
Estado
Condiciones
Condiciones
Intervención / Tratamiento
Intervención / Tratamiento
Tipo de estudio
Tipo de estudio
Inscripción (Estimado)
Inscripción
Fase
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
Estudio Contacto
- Nombre: Chávez Bourgeois, Dr.
- Número de teléfono: +34 937 37 64 00
- Correo electrónico: marionminisa@gmail.com
Ubicaciones de estudio
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Barcelona, España
- Cosmocare
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Contacto:
- Fernández Botello
- Número de teléfono: +34 937 37 64 00
- Correo electrónico: alfonsofernandez@cosmocare.eu
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Criterios de participación
Criterio de elegibilidad
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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:
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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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Triple
Número de brazos
Armas e Intervenciones
Grupo de participantes/brazoGrupo de participantes/brazo |
Intervención / TratamientoIntervención / Tratamiento |
|---|---|
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Comparador de placebos: Cápsula de placebo
|
Placebo will be taken daily for 2 months |
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Experimental: Dietary supplement capsule
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Dietary supplement will be taken daily for 2 months |
¿Qué mide el estudio?
Medidas de resultado primarias
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change from Baseline in the number of shed hairs at 3 Months
Periodo de tiempo: From enrollment to the end of treatment at 3 months
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Hair loss will be evaluated by wash and combing test |
From enrollment to the end of treatment at 3 months
|
Colaboradores e Investigadores
Patrocinador
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Inicio del estudio
Finalización primaria (Estimado)
Finalización primaria
Finalización del estudio (Estimado)
Finalización del estudio
Fechas de registro del estudio
Enviado por primera vez
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Publicado por primera vez
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización publicada
Última actualización enviada que cumplió con los criterios de control de calidad
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
Otros números de identificación del estudio
- CT26786
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Only data included in the publication will be shared.
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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