アンドロゲン性脱毛症の治療における多血小板血漿療法の有効性の評価
The study team will assess the efficacy of platelet-rich plasma therapy, a special blood product which is from the participant's own body, in the treatment of androgenic alopecia (also known as male pattern hair loss) in females.
調査の概要
状態
条件
詳細な説明
Androgenic alopecia, or male-pattern hair loss affects both men and women. This hair loss pattern is typically characterized by thinning at the crown of scalp and/or M-shaped hair line in males or diffuse thinning throughout in females. Platelet-rich plasma (PRP) therapy has recently been studied as a hair rejuvenation therapy in patients with non-inflammatory alopecia. Though the mechanism of action is not well understood, PRP is thought to promote angiogenesis and enhance blood flow around hair follicles via platelet-derived growth factor (PDGF), transforming growth factor (TGF), and vascular endothelial growth factor (VEGF). The primary objective of the study is to determine whether PRP, administered once monthly for 3 months improves clinical outcomes and quality of life in females with androgenic alopecia. This is a randomized, placebo-controlled, double-blind, half-head, single center clinical study where sixteen subjects with androgenic alopecia will be recruited. Dermatology Life Quality Index will be assessed at several time points. Disease severity will be measured using the Severity of Alopecia Tool (SALT), Alopecia Density and Extent Score (ALODEX); Trichoscan images will be captured to document participants' clinical progress. Adverse events will be recorded at each visit, treatment will be discontinued if any subject experience a serious adverse event. Treatment visits will take place at baseline, 4 weeks (1 month), 8 weeks (2 months), and 12 weeks (3 month). A follow-up, non-treatment visit will take place at 24 weeks (6 months). The study team hypothesizes that PRP will improve DLQI, SALT, ALODEX, hair count (number of hairs/0.65 cm2), hair density (number of hairs/cm2), hair diameter, anagen to telogen ratio, and vellus hair to terminal hair ratio in female subjects with androgenic alopecia.
研究の種類
入学 (推定)
段階
- 初期フェーズ 1
連絡先と場所
研究連絡先
- 名前：Research Coordinator
- 電話番号：336-716-2903
- メール：irichard@wakehealth.edu
研究場所
-
-
North Carolina
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Winston-Salem、North Carolina、アメリカ、27104
- Wake Forest University Baptist Health
-
-
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:
- Female ≥18 years of age at baseline visit.
- Documentation of androgenic alopecia diagnosis as evidenced by one or more clinical features
- Not currently on any treatment for alopecia, or has undergone 2-week washout period if recently on medication(s) for alopecia
- Written informed consent obtained from subject and ability for subject to comply with the requirements of the study
Exclusion Criteria:
- Pregnant or breastfeeding
- Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.
- Have an infection, metastatic disease or certain skin conditions (ie. Psoriasis) which could worsen or spread with injections
- Diagnosed with a blood or bleeding disorder
- Diagnosed with anemia
- Currently on anticoagulant therapy
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：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Group A
At the baseline visit subjects will be randomized to either group A or group B. Group A will receive PRP on left side of scalp and placebo (saline solution) on right side of scalp. |
Group A will receive PRP on left side of scalp and placebo (saline solution) on right side of scalp. |
|
実験的：Group B
At the baseline visit subjects will be randomized to either group A or group B. Group B will receive PRP on right side of scalp and placebo (saline solution) on left side of scalp. |
Group B will receive PRP on right side of scalp and placebo (saline solution) on left side of scalp. |
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 |
|---|---|---|
|
Change in Severity of Alopecia Tool (SALT) from baseline
時間枠：6 months
|
Change in Severity of Alopecia Tool (SALT) from baseline. SALT scoring - This calculation is based on a scoring system. The scalp is divided into the following 4 areas: Vertex: 40% (0.4) of scalp surface area. Right profile of scalp: 18% (0.18) of scalp surface area. Left profile of scalp: 18% (0.18) of scalp surface area. Posterior aspect of scalp: 24% (0.24) of scalp surface area. Percentage of hair loss in any of these areas is the percentage hair loss multiplied by percent surface area of the scalp in that area. SALT score is the sum of percentage of hair loss in all the above-mentioned areas. For e.g., if the percentage hair loss in vertex, right profile, left profile and posterior aspect is 20, 30, 40 and 50% respecively; then, SALT score = (20 ´ 0.4) = (30 ´ 0.18) + (40 ´ 0.18) + (50 ´ 0.24) = 8+5.4+7.2+12 = 32.6 Lower score denote better outcomes. |
6 months
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in Hair Count (number of hairs/0.65cm^2)
時間枠：6 months
|
Change in Hair Count (number of hairs/0.65cm^2), as assessed via Trichoscan |
6 months
|
|
Change in Hair Density (number of hairs/cm^2)
時間枠：6 months
|
Change in Hair Density (number of hairs/cm^2), as assessed via Trichoscan |
6 months
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in Hair Diameter
時間枠：6 months
|
Change in Hair Diameter, as assessed via Trichoscan |
6 months
|
|
Anagen to Telogen Ratio
時間枠：6 months
|
Anagen to Telogen Ratio, as assessed via Trichoscan |
6 months
|
|
Vellus Hair to Terminal Hair Ratio
時間枠：6 months
|
Vellus Hair to Terminal Hair Ratio, as assessed via Trichoscan |
6 months
|
|
Change in Dermatology Life Quality Index (DLQI)
時間枠：6 months
|
Change in Dermatology Life Quality Index (DLQI) 10 question are asked pertaining to symptoms and feelings, daily activities, leisure, work and school, personal relationships and treatment. The scoring of each answer is as follows: Very much scored 3 A lot scored 2 A little scored 1 Not at all scored 0 Not relevant scored 0 Question unanswered scored 0 Question 7: "prevented work or studying" scored 3 The DLQI is calculated by adding the score of each question. The maximum score is 30 and the minimum is 0. The higher the score, the more quality of life is impaired. Meaning of DLQI Scores 0-1 = no effect at all on patient's life 2-5 = small effect on patient's life 6-10 = moderate effect on patient's life 11-20 = very large effect on patient's life 21-30 = extremely large effect on patient's life |
6 months
|
協力者と研究者
捜査官
- 主任研究者：Rita Pichardo, MD、Wake Forest University School of Medicine, Department of Dermatology
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
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
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- IRB00045844
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
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
米国で製造され、米国から輸出された製品。
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