Um estudo avaliando a eficácia e a segurança da solução tópica SM04554 em indivíduos do sexo masculino com alopecia androgenética
Estudo multicêntrico, randomizado, duplo-cego, controlado por placebo da eficácia e segurança de concentrações de 0,15% e 0,25% da solução tópica SM04554 em indivíduos do sexo masculino com alopecia androgenética
This multi-center, randomized, double-blind, placebo-controlled study, conducted in Turkey, will assess the efficacy and safety of topical SM04554 solution (0.15% and 0.25%) applied daily to the scalp of male androgenetic alopecia (AGA) subjects.
Visão geral do estudo
Status
Condições
Descrição detalhada
This study was a multicenter, randomized, double-blind, placebo-controlled, parallel-group study conducted in Turkey of 2 different strengths of topical SM04554 solution applied QD to the scalp of male androgenetic alopecia (AGA) subjects - otherwise known as male pattern baldness.
Following a screening period of up to 2 weeks, subjects participated in the study for 54 weeks (48 weeks of treatment and 6 weeks of follow-up). Subjects were randomized into 1 of 3 groups in a 2:2:1 randomization scheme: SM04554 0.15% solution, SM04554 0.25% solution, and vehicle placebo.
Primary outcome of this study was change in absolute hair count as assessed by phototrichogram, a non-invasive and reproducible method to measure changes in hair.
Tipo de estudo
Inscrição (Real)
Estágio
- Fase 2
- Fase 3
Contactos e Locais
Locais de estudo
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Ankara, Turquia (Türkiye), 06100
- Research Site
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Ankara, Turquia (Türkiye), 06110
- Research Site
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Ankara, Turquia (Türkiye), 06680
- Research Site
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Bursa, Turquia (Türkiye), 16059
- Research Site
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Denizli, Turquia (Türkiye), 20070
- Research Site
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Istanbul, Turquia (Türkiye), 34098
- Research Site
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Istanbul, Turquia (Türkiye), 34668
- Research Site
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Izmir, Turquia (Türkiye), 35180
- Research Site
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Kayseri, Turquia (Türkiye), 38039
- Research Site
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Kocaeli, Turquia (Türkiye), 41380
- Research Site
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Mersin, Turquia (Türkiye), 33343
- Research Site
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Samsun, Turquia (Türkiye), 55139
- Research Site
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Trabzon, Turquia (Türkiye), 61080
- Research Site 1
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Trabzon, Turquia (Türkiye), 61080
- Research Site 2
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- Being a Turkish citizen
- Clinical diagnosis of AGA with Norwood-Hamilton Classification score of 3V or 4
- Willing to inform females, with whom they may interact, that they are using a topical investigational product and direct contact should be avoided as potential harm to a fetus is unknown
- Willing and able to attend all study visits
- Willing to maintain the same hair style and length as at the study start for the duration of the study
- Willing to not use semi-permanent hair products (e.g., color, texturizers, relaxers) for the duration of the study; daily styling products (e.g., hair gel, mousse, styling spray) will be allowed on non-study visit days
- Willing to use mild non-medicated shampoo and conditioner for the duration of the study
- Able to read and understand Turkish
- Ability to comprehend and willing to sign an informed consent form
Exclusion Criteria:
- Males who are sexually active, and have a partner who is capable of becoming pregnant, if neither has had surgery to become sterilized, and/or who are not willing to use condom or whose partner is not using a highly effective method of birth control that includes double barrier, intrauterine device, or hormonal contraceptive combined with single barrier, or abstinence during the study treatment period until 90 days post last dose of study medication
- Clinical diagnosis of alopecia areata or other non-AGA forms of alopecia
- Scalp hair loss on the treatment area, due to disease, injury, or medical therapy
- History of surgical correction (e.g., hair transplantation, scalp reduction) of hair loss on the scalp
- Previous exposure to SM04554
- Use of any products (e.g., finasteride, minoxidil, platelet rich plasma, biotin) or devices (e.g., laser light therapy) purported to promote scalp hair growth within 24 weeks prior to the start of the study
- Use of anti-androgenic therapies (e.g., spironolactone, flutamide, cyproterone acetate, cimetidine) within 12 weeks prior to the start of the study
- Use of medications that potentially cause drug-induced hair loss (e.g., depotestosterone, haloperidol, methotrexate, methylprednisolone, prednisone, testosterone, divalproex sodium) within 12 weeks prior to the start of the study
- Current use of an occlusive wig, hair extensions, or hair weaves
- History of hypersensitivity or allergies to any ingredient of the study medication
- Participation in any other investigational drug or medical device trial, which includes or included administration of an investigational study medication or medical device, within 30 days or 5 half-lives of the investigational agent, whichever is longer, prior to the start of the study
- Use of semi-permanent hair products (e.g., color, texturizers, relaxers) within 30 days prior to the start of the study
- Use of medicated shampoo or conditioner (medicated shampoo and conditioner refers to any prescription shampoo or conditioner as well as any over-the-counter medicated shampoo or conditioner, such as those for treatment of dandruff or promoting hair growth) within 30 days prior to the start of the study
- Subjects who are immediate family members (spouse, parent, child, or sibling; biological or legally adopted) of personnel directly affiliated with the study at the investigative site, or are directly affiliated with the study at the investigative site
- Subjects employed by Samumed, LLC or Samumed Turkey, or any of its affiliates or development partners (i.e., an employee, temporary contract worker, or designee) responsible for the conduct of the study
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Triplo
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: Topical SM04554 0.15% solution
Topical SM04554 0.15% solution, once daily for up to 48 weeks |
Study medication application will be performed by the individual subject at approximately the same time each day. |
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Experimental: Topical SM04554 0.25% solution
Topical SM04554 0.25% solution, once daily for up to 48 weeks |
Study medication application will be performed by the individual subject at approximately the same time each day. |
|
Comparador de Placebo: Vehicle
Topical vehicle solution, once daily for up to 48 weeks |
Vehicle solution application will be performed by the individual subject at approximately the same time each day. |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Absolute Non-vellus Hair Count in Target Area
Prazo: Week 48
|
Non-vellus hair count was determined by phototrichogram. Standardized phototrichogram images of the treatment area were taken on Visit Day 1 (pre-treatment), as well as at visits occuring at Weeks 12, 24, 36, and 48. A rectangular area of the subject's hair with dimensions 20 x 15 mm was clipped to between 0.6 and 0.9 mm in length prior to performing the phototrichogram. Virtual tattoo technology was used to anchor the phototrichogram. Images were uploaded from sites to the blinded vendor where assessment of the phototrichogram took place. |
Week 48
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Absolute Non-vellus Hair Count in Target Area
Prazo: Weeks 12, 24, and 36
|
Non-vellus hair count was determined by phototrichogram. Standardized phototrichogram images of the treatment area were taken on Visit Day 1 (pre-treatment), as well as at visits occuring at Weeks 12, 24, 36, and 48. A rectangular area of the subject's hair with dimensions 20 x 15 mm was clipped to between 0.6 and 0.9 mm in length prior to performing the phototrichogram. Virtual tattoo technology was used to anchor the phototrichogram. Images were uploaded from sites to the blinded vendor where assessment of the phototrichogram took place. |
Weeks 12, 24, and 36
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Absolute Vellus Hair Count in Target Area
Prazo: Weeks 12, 24, 36 and 48
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Vellus hair count was determined by phototrichogram. Standardized phototrichogram images of the treatment area were taken on Visit Day 1 (pre-treatment), as well as at visits occuring at Weeks 12, 24, 36, and 48. A rectangular area of the subject's hair with dimensions 20 x 15 mm was clipped to between 0.6 and 0.9 mm in length prior to performing the phototrichogram. Virtual tattoo technology was used to anchor the phototrichogram. Images were uploaded from sites to the blinded vendor where assessment of the phototrichogram took place. |
Weeks 12, 24, 36 and 48
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Absolute Total Hair Count in Target Area
Prazo: Weeks 12, 24, 36 and 48
|
Total hair count was determined by phototrichogram. Standardized phototrichogram images of the treatment area were taken on Visit Day 1 (pre-treatment), as well as at visits occuring at Weeks 12, 24, 36, and 48. A rectangular area of the subject's hair with dimensions 20 x 15 mm was clipped to between 0.6 and 0.9 mm in length prior to performing the phototrichogram. Virtual tattoo technology was used to anchor the phototrichogram. Images were uploaded from sites to the blinded vendor where assessment of the phototrichogram took place. |
Weeks 12, 24, 36 and 48
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Change From Baseline in Non-vellus Hair Count in Target Area
Prazo: Baseline, and Weeks 12, 24, 36 and 48
|
Change from baseline in non-vellus hair count in target area by PTG analysis. Non-vellus hair count was determined by phototrichogram. Standardized phototrichogram images of the treatment area were taken on Visit Day 1 (pre-treatment), as well as at visits occuring at Weeks 12, 24, 36, and 48. A rectangular area of the subject's hair with dimensions 20 x 15 mm was clipped to between 0.6 and 0.9 mm in length prior to performing the phototrichogram. Virtual tattoo technology was used to anchor the phototrichogram. Images were uploaded from sites to the blinded vendor where assessment of the phototrichogram took place. |
Baseline, and Weeks 12, 24, 36 and 48
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Change From Baseline in Vellus Hair Count in Target Area
Prazo: Baseline, and Weeks 12, 24, 36 and 48
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Change from baseline in vellus hair count in target area by PTG analysis. Vellus hair count was determined by phototrichogram. Standardized phototrichogram images of the treatment area were taken on Visit Day 1 (pre-treatment), as well as at visits occuring at Weeks 12, 24, 36, and 48. A rectangular area of the subject's hair with dimensions 20 x 15 mm was clipped to between 0.6 and 0.9 mm in length prior to performing the phototrichogram. Virtual tattoo technology was used to anchor the phototrichogram. Images were uploaded from sites to the blinded vendor where assessment of the phototrichogram took place. |
Baseline, and Weeks 12, 24, 36 and 48
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Change From Baseline in Total Hair Count in Target Area
Prazo: Baseline, and Weeks 12, 24, 36 and 48
|
Change from baseline in total hair count in target area by PTG analysis. Vellus and non-vellus hair count was determined by phototrichogram. Standardized phototrichogram images of the treatment area were taken on Visit Day 1 (pre-treatment), as well as at visits occuring at Weeks 12, 24, 36, and 48. A rectangular area of the subject's hair with dimensions 20 x 15 mm was clipped to between 0.6 and 0.9 mm in length prior to performing the phototrichogram. Virtual tattoo technology was used to anchor the phototrichogram. Images were uploaded from sites to the blinded vendor where assessment of the phototrichogram took place. |
Baseline, and Weeks 12, 24, 36 and 48
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Change From Baseline in Average Non-vellus Hair Shaft Thickness in Target Area
Prazo: Baseline, and Weeks 12, 24, 36 and 48
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Change from baseline in average non-vellus hair shaft thickness in target area by PTG analysis. Non-vellus hair shaft thickness was determined by phototrichogram. Standardized phototrichogram images of the treatment area were taken on Visit Day 1 (pre-treatment), as well as at visits occuring at Weeks 12, 24, 36, and 48. A rectangular area of the subject's hair with dimensions 20 x 15 mm was clipped to between 0.6 and 0.9 mm in length prior to performing the phototrichogram. Virtual tattoo technology was used to anchor the phototrichogram. Images were uploaded from sites to the blinded vendor where assessment of the phototrichogram took place. |
Baseline, and Weeks 12, 24, 36 and 48
|
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Change From Baseline in Average Non-vellus Hair Density in Target Area
Prazo: Baseline, and Weeks 12, 24, 36 and 48
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Change from baseline in average non-vellus hair density (cumulative non-vellus hair shaft thickness) in target area by PTG analysis. Non-vellus hair shaft thickness was determined by phototrichogram. Standardized phototrichogram images of the treatment area were taken on Visit Day 1 (pre-treatment), as well as at visits occuring at Weeks 12, 24, 36, and 48. A rectangular area of the subject's hair with dimensions 20 x 15 mm was clipped to between 0.6 and 0.9 mm in length prior to performing the phototrichogram. Virtual tattoo technology was used to anchor the phototrichogram. Images were uploaded from sites to the blinded vendor where assessment of the phototrichogram took place. For this outcome, the cumulative non-vellus hair shaft thickness in the measurement area was summarized. |
Baseline, and Weeks 12, 24, 36 and 48
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Improvement in Subject Assessment of Hair Growth
Prazo: Weeks 6, 12, 18, 24, 30, 36, 42 and 48
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Subjects will complete a questionnaire for hair growth while referencing the global scalp photograph taken at the visit as compared to their baseline global scalp photograph. The scale for the questionnaire ranges from -3 to +3 (-3 indicates the worst outcome and +3 indicates the best outcome). Improvement is defined as +1, +2, and +3: Much Better. |
Weeks 6, 12, 18, 24, 30, 36, 42 and 48
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Change From Baseline in Subject Assessment of Hair Satisfaction
Prazo: Baseline, and Weeks 6, 12, 18, 24, 30, 36, 42 and 48
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Subjects will complete a questionnaire for hair satisfaction while referencing the global scalp photograph taken at the visit as compared to their baseline global scalp photograph. The scale for the questionnaire ranges from -3 to +3 (-3 indicates the worst outcome and +3 indicates the best outcome). The change from baseline is the difference between the baseline and follow-up response. |
Baseline, and Weeks 6, 12, 18, 24, 30, 36, 42 and 48
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Diretor de estudo: Yusuf Yazici, M.D., Biosplice Therapeutics, Inc.
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- SM04554-AGA-05
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