En studie av sikkerheten, toleransen og effekten av aktuell SM04554-løsning hos mannlige personer med androgenetisk alopecia (AGA)
En fase 2, multisenter, randomisert, dobbeltblind, kjøretøykontrollert studie av sikkerhet, tolerabilitet og effekt av 0,15 % og 0,25 % konsentrasjoner av topisk SM04554-løsning hos mannlige personer med androgenetisk alopecia (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).
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Faktiske)
Fase
- Fase 2
Kontakter og plasseringer
Studiesteder
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California
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Encinitas, California, Forente stater, 92024
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San Diego, California, Forente stater, 92123
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Connecticut
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New Haven, Connecticut, Forente stater, 06511
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Florida
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Miami, Florida, Forente stater, 33143
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West Palm Beach, Florida, Forente stater, 33401
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Indiana
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Plainfield, Indiana, Forente stater
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Kansas
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Wichita, Kansas, Forente stater, 67207
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Michigan
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Clinton Township, Michigan, Forente stater, 48038
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Detroit, Michigan, Forente stater, 48202
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Minnesota
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Fridley, Minnesota, Forente stater, 55432
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New Mexico
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Albuquerque, New Mexico, Forente stater, 87106
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New York
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New York, New York, Forente stater
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Stony Brook, New York, Forente stater, 11790
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North Carolina
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Winston-Salem, North Carolina, Forente stater, 27104
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Ohio
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Cleveland, Ohio, Forente stater, 44195
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Oregon
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Portland, Oregon, Forente stater, 97210
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Portland, Oregon, Forente stater, 97223
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Texas
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Austin, Texas, Forente stater, 78759
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College Station, Texas, Forente stater, 77845
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Dallas, Texas, Forente stater, 75246
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Houston, Texas, Forente stater
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Utah
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Salt Lake City, Utah, Forente stater, 84117
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Virginia
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Lynchburg, Virginia, Forente stater, 24501
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Norfolk, Virginia, Forente stater, 23507
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: 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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Eksperimentell: 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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Placebo komparator: 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. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Change From Baseline in Non-vellus Hair Count
Tidsramme: Day 45, Day 90, and Day 135
|
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
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Change in Hair Growth as Assessed by the Investigator
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Studieleder: Yusuf Yazici, M.D., Biosplice Therapeutics, Inc.
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Antatt)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- SM04554-AGA-02
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
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