Studie bezpečnosti, snášenlivosti a účinnosti topického roztoku SM04554 u mužů s androgenetickou alopecií (AGA)
Fáze 2, multicentrická, randomizovaná, dvojitě zaslepená, vozidlem řízená studie bezpečnosti, snášenlivosti a účinnosti 0,15% a 0,25% koncentrace topického roztoku SM04554 u mužů s androgenetickou alopecií (AGA)
The purpose of this study is to characterize the safety, tolerability, and efficacy of topical SM04554 solution (0.15% and 0.25%) applied to the scalp of male subjects with Androgenetic Alopecia (AGA).
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Typ studie
Zápis (Aktuální)
Fáze
- Fáze 2
Kontakty a umístění
Studijní místa
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California
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Encinitas, California, Spojené státy, 92024
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San Diego, California, Spojené státy, 92123
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Connecticut
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New Haven, Connecticut, Spojené státy, 06511
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Florida
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Miami, Florida, Spojené státy, 33143
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West Palm Beach, Florida, Spojené státy, 33401
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Indiana
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Plainfield, Indiana, Spojené státy
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Kansas
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Wichita, Kansas, Spojené státy, 67207
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Michigan
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Clinton Township, Michigan, Spojené státy, 48038
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Detroit, Michigan, Spojené státy, 48202
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Minnesota
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Fridley, Minnesota, Spojené státy, 55432
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New Mexico
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Albuquerque, New Mexico, Spojené státy, 87106
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New York
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New York, New York, Spojené státy
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Stony Brook, New York, Spojené státy, 11790
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North Carolina
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Winston-Salem, North Carolina, Spojené státy, 27104
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Ohio
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Cleveland, Ohio, Spojené státy, 44195
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Oregon
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Portland, Oregon, Spojené státy, 97210
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Portland, Oregon, Spojené státy, 97223
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Texas
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Austin, Texas, Spojené státy, 78759
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College Station, Texas, Spojené státy, 77845
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Dallas, Texas, Spojené státy, 75246
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Houston, Texas, Spojené státy
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Utah
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Salt Lake City, Utah, Spojené státy, 84117
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Virginia
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Lynchburg, Virginia, Spojené státy, 24501
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Norfolk, Virginia, Spojené státy, 23507
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
Inclusion Criteria:
- Clinical diagnosis of AGA
- 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 to maintain the same hair style as at 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 will be allowed (e.g., hair gel, mousse, styling spray).
- Willing to use a mild non-medicated shampoo and conditioner for the duration of the study
- Willing to receive a small scalp tattoo
- Able to read and understand English
Exclusion Criteria:
- 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
- Males who are sexually active and have a partner who is capable of becoming pregnant, neither of whom have had surgery to become sterilized, that are not using an effective method of birth control and are not willing to use an effective method of birth control during the study treatment period until 90 days post last dose of study medication
- Current skin disease (e.g., psoriasis, atopic dermatitis, skin cancer, eczema, sun damage, seborrheic dermatitis), cuts and/or abrasions on the scalp or condition (e.g., sunburn, tattoos) on the treatment area that, in the opinion of the Investigator, might put the subject at risk or interfere with the study conduct or evaluations
- History of surgical correction of hair loss on the scalp
- Previous exposure to SM04554
- Use of any products or devices purported to promote scalp hair growth (e.g., finasteride or minoxidil) within the 24 weeks prior to study start
- Use of anti-androgenic therapies (e.g., spironolactone, flutamide, cyproterone acetate, cimetidine) within 12 weeks prior to study start
- History of hair transplants
- Current use of an occlusive wig, hair extensions, or hair weaves
- Participation in any other investigational drug or medical device trial, which 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 study start
- Subjects with a history of clinically significant cardiac arrhythmia as determined by the Investigator
- Subjects with clinically significant findings from medical history, clinical laboratory tests, electrocardiogram (ECG), or vital signs that, in the opinion of the Investigator, could interfere with the objectives of the study or put the subject at risk
- Subjects unwilling to refrain from sperm donation during the study treatment period until 90 days post last dose of study medication
- Subjects with pregnant partners at study start
- Use of semi-permanent hair products (e.g., color, texturizers, relaxers) within 30 days prior to study start
- Use of medicated shampoo or conditioner within 30 days prior to study start
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Dvojnásobek
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: Topical SM04554 0.15% solution
Topical SM04554 0.15% solution, applied once a day for 90 days |
Study medication application will be performed by the individual subject at approximately the same time each day. |
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Experimentální: Topical SM04554 0.25% solution
Topical SM04554 0.25% solution, applied once a day for 90 days |
Study medication application will be performed by the individual subject at approximately the same time each day. |
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Komparátor placeba: Vehicle
Topical vehicle solution, applied once a day for 90 days |
Vehicle solution application will be performed by the individual subject at approximately the same time each day. |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Change From Baseline in Non-vellus Hair Count
Časové okno: Day 45, Day 90, and Day 135
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Change from baseline in non-vellus hair count over time. Non-vellus hair count was determined by macrophotography. Standardized macrophotography color photographs of the treatment area were taken on Visit Day 0 (pre-treatment), as well as on Visit Days 45 and 90, and 135. A circular area of the subject's hair 1.9 cm in diameter was clipped to approximately 1 mm in length prior to performing the macrophotography. On Visit Day 0, a scalp tattoo approximately 1 mm in size and located in the center of the target area of hair was applied to anchor the macrophotography. Photos were uploaded from sites to the vendor where blinded assessment of the macrophotography took place. |
Day 45, Day 90, and Day 135
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Change in Subject Assessment of Hair Growth and Quality
Časové okno: Day 45, Day 90, and Day 135
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Change in Men's Hair Growth Questionnaire (MHGQ) over time as compared to Baseline. The MHGQ is a subject-completed assessment that asks the subject to evaluate his hair growth and quality since the start of the study. |
Day 45, Day 90, and Day 135
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Change in Hair Growth as Assessed by the Investigator
Časové okno: Day 45, Day 90, and Day 135
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Change in hair growth over time as compared to Baseline, as assessed by the investigator, using a 7-point scale from -3 (greatly decreased) to +3 (greatly increased). Responses were analyzed using logistic regression modeling improvement vs no change/worsening of hair status at each visit. |
Day 45, Day 90, and Day 135
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Impact of AGA on Quality of Life
Časové okno: Day 45, Day 90, and Day 135
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Change from baseline in subject responses to the Kingsley Alopecia Profile (KAP) questionnaire over time. The KAP is a validated, patient-reported outcome that quantitatively measure the impact androgenetic alopecia on the subject's quality of life. Each of the 38 KAP 5-category Likert-scaled questions was scored +2 'Strongly Agree' to -2 'Strongly Disagree.' The KAP score was summed across all 38 questions for a score ranging from +76 to -76, with higher scores indicating an increasing negative impact on quality of life. Change from baseline was calculated as visit - baseline such that negative values reflecting improving quality of life. |
Day 45, Day 90, and Day 135
|
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Change From Baseline in Total Sum of Hair Width
Časové okno: Day 45, Day 90, and Day 135
|
Non-vellus hair width was determined by macrophotography. Standardized macrophotography color photographs of the treatment area were taken on Visit Day 0 (pre-treatment), as well as on Visit Days 45 and 90, and 135. A circular area of the subject's hair 1.9 cm in diameter was clipped to approximately 1 mm in length prior to performing the macrophotography. On Visit Day 0, a scalp tattoo approximately 1 mm in size and located in the center of the target area of hair was applied to anchor the macrophotography. Photos were uploaded from sites to the vendor where blinded assessment of the macrophotography took place. While the protocol and SAP listed this outcome as hair density, the actual outcome analyzed was the total sum of non-vellus hair width in microns within the target area provided by macrophotography. |
Day 45, Day 90, and Day 135
|
Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Ředitel studie: Yusuf Yazici, M.D., Biosplice Therapeutics, Inc.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhadovaný)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- SM04554-AGA-02
Informace o lécích a zařízeních, studijní dokumenty
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