男性型脱毛症の男性被験者におけるSM04554局所溶液の有効性と安全性を評価する研究
アンドロゲン性脱毛症の男性被験者における局所SM04554溶液の0.15％および0.25％濃度の有効性と安全性に関する多施設、無作為化、二重盲検、プラセボ対照研究
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.
調査の概要
状態
条件
詳細な説明
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.
研究の種類
入学 (実際)
段階
- フェーズ2
- フェーズ 3
連絡先と場所
研究場所
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Ankara、トルコ（Türkiye）、06100
- Research Site
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Ankara、トルコ（Türkiye）、06110
- Research Site
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Ankara、トルコ（Türkiye）、06680
- Research Site
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Bursa、トルコ（Türkiye）、16059
- Research Site
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Denizli、トルコ（Türkiye）、20070
- Research Site
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Istanbul、トルコ（Türkiye）、34098
- Research Site
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Istanbul、トルコ（Türkiye）、34668
- Research Site
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Izmir、トルコ（Türkiye）、35180
- Research Site
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Kayseri、トルコ（Türkiye）、38039
- Research Site
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Kocaeli、トルコ（Türkiye）、41380
- Research Site
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Mersin、トルコ（Türkiye）、33343
- Research Site
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Samsun、トルコ（Türkiye）、55139
- Research Site
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Trabzon、トルコ（Türkiye）、61080
- Research Site 1
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Trabzon、トルコ（Türkiye）、61080
- Research Site 2
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：トリプル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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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実験的：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. |
|
プラセボコンパレーター：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. |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Absolute Non-vellus Hair Count in Target Area
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Absolute Non-vellus Hair Count in Target Area
時間枠：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
|
|
Absolute Vellus Hair Count in Target Area
時間枠：Weeks 12, 24, 36 and 48
|
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
|
|
Absolute Total Hair Count in Target Area
時間枠：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
時間枠：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
時間枠：Baseline, and Weeks 12, 24, 36 and 48
|
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
時間枠：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
|
|
Change From Baseline in Average Non-vellus Hair Shaft Thickness in Target Area
時間枠：Baseline, and Weeks 12, 24, 36 and 48
|
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
|
|
Change From Baseline in Average Non-vellus Hair Density in Target Area
時間枠：Baseline, and Weeks 12, 24, 36 and 48
|
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
|
|
Improvement in Subject Assessment of Hair Growth
時間枠：Weeks 6, 12, 18, 24, 30, 36, 42 and 48
|
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
時間枠：Baseline, and Weeks 6, 12, 18, 24, 30, 36, 42 and 48
|
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
|
協力者と研究者
捜査官
- スタディディレクター：Yusuf Yazici, M.D.、Biosplice Therapeutics, Inc.
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- SM04554-AGA-05
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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