Evaluating Photodynamic Therapy Used to Treat Cutaneous Squamous Cell Carcinoma in Situ (isSCC) on the Face, Upper Extremities & Trunk.
An Investigator Initiated Study to Evaluate the Safety and Efficacy of Aminolevulinic Acid 20% Topical Solution (Levulan® Kerastick®) (ALA) With Blue Light Model 4170E in the Treatment of Cutaneous Squamous Cell Carcinoma in Situ (isSCC) Located on the Face, Upper Extremities and Trunk.
The goal of this clinical trial is to test how safe and effective it is to treat early form of cancer cells found in the upper skin layer of the face, upper extremities and trunk, using a light sensitive cream used in combination with a light source.
The main questions this trial aims to answer are:
- to confirm using laboratory testing, how much of the affected skin cancer section the treatment was able to remove, and;
- seeing how many participants had no remaining affected skin cancer sections after treatment.
Participants who qualify will be asked to complete 12 visits in total and will receive a total of two treatments, after voluntarily consent has been given.
調査の概要
状態
詳細な説明
In the study, participants will be asked to complete the following:
- Provide basic personal information (including date of birth, gender, race and ethnicity)
- Provide their medical/ surgical history and perform a medical exam (including but not limited to physical exam, skin type, vital signs, height, weight and urine pregnancy test collection)
- Follow study rules such as avoiding certain medications and treatments
- Allow photographs of the area of skin cancer being treated on the face or upper extremities/ trunk.
- Provide information on any medications, treatments or reactions that started after the study began
- Allow two treatments on the skin cancer area of the face upper extremities/ trunk using a light sensitive cream used in combination with a light source
- Allow clinical documentation of the treatment, such as how well the treatment was tolerated, any skin reaction or side effects
- Allow surgery to remove the skin cancer area from the face or upper extremities/ trunk for Laboratory testing
To qualify for this trial, participants must:
- be an adult (18 years of age or older)
- give voluntary written consent
- have a recently diagnosed (less than six months from first visit) skin cancer area on the face or upper extremities/ trunk that meets surgery size requirements
- be willing to follow study instructions and complete study requirements, including not using non-approved lotions and creams on the treatments areas
- (if female) not be pregnant before and during the study and agree to use acceptable forms of birth control
- confirm they are not sensitive to any of the study treatment ingredients
All surgery samples collected from the participants towards the end of the study will be sent to a laboratory for testing.
All photographs of the treatment area collected during the study will be used as study data.
研究の種類
入学 (推定)
段階
- フェーズ2
連絡先と場所
研究連絡先
- 名前：Clinical Coordinator
- 電話番号：305-933-6716
- メール：info@centerforclinicalandcosmeticresearch.com
研究場所
-
-
Florida
-
Aventura、Florida、アメリカ、33180
- 募集
- Center for Clinical and Cosmetic Research
-
コンタクト：
- Clinical Coordinator
- 電話番号：305-933-6716
- メール：info@centerforclinicalandcosmeticresearch.com
-
主任研究者：
- Mark S. Nestor, MD, PhD
-
-
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:
- Must be an adult (18 years of age or older).
- Voluntary written consent required.
- Must have a recently diagnosed (no more than six months from first study visit) facial or trunk/ upper extremities isSCC (Squamous Cell Carcinoma in situ) lesion that meets surgery excision size requirements.
- Cannot have other dermatological disease in the isSCC target area.
- Must be willing to follow study instructions and complete study requirements, including not using non-approved lotions and creams on the treatments areas.
- If female, cannot be pregnant before and during the study and agree to use acceptable forms of birth control.
Exclusion Criteria:
- Sensitive to any of the study treatment ingredients.
- Pregnant or lactating.
- Medical laboratory evidence of other non-isSCC tumor in the target lesion biopsy specimen.
- History of recurrence in the target isSCC lesion.
- Medical laboratory evidence of certain growth patterns in the target lesion biopsy specimen.
- Chronic medical condition that in the Investigators opinion will interfere in the trial or affect participant safety.
- History of abnormal heart muscles.
- Currently participating in a research study or have been treated with an investigational product within 30 days from first study treatment.
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：非ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Facial isSCC Photodynamic Therapy (Blue light dose 20 J/cm2)
8 participants will be enrolled to this arm. |
Participants will have their isSCC lesions prepped then treated with Aminolevulinic Acid 20% Topical Solution (Levulan® Kerastick® Applicators) (ALA), followed by Blue Light therapy administered for 16 minutes and 40 seconds to deliver the total desired light dose to the isSCC lesion.
他の名前：
|
|
実験的：Trunk and/or upper extremities isSCC Photodynamic Therapy (Blue light dose 20 J/cm2)
8 participants will be enrolled to this arm. |
Participants will have their isSCC lesions prepped then treated with Aminolevulinic Acid 20% Topical Solution (Levulan® Kerastick® Applicators) (ALA), followed by Blue Light therapy administered for 16 minutes and 40 seconds to deliver the total desired light dose to the isSCC lesion.
他の名前：
|
|
実験的：Facial isSCC Photodynamic Therapy (Blue light dose 10 J/cm2)
7 participants will be enrolled to this arm. |
Participants will have their isSCC lesions prepped then treated with Aminolevulinic Acid 20% Topical Solution (Levulan® Kerastick® Applicators) (ALA), followed by Blue Light therapy administered for 8 minutes and 20 seconds to deliver the total desired light dose to the isSCC lesion.
他の名前：
|
|
実験的：Trunk and/or upper extremities isSCC Photodynamic Therapy (Blue light dose 10 J/cm2)
7 participants will be enrolled to this arm. |
Participants will have their isSCC lesions prepped then treated with Aminolevulinic Acid 20% Topical Solution (Levulan® Kerastick® Applicators) (ALA), followed by Blue Light therapy administered for 8 minutes and 20 seconds to deliver the total desired light dose to the isSCC lesion.
他の名前：
|
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 |
|---|---|---|
|
Number of participants with Histological Clearance of treated isSCC lesion
時間枠：Up to 63 days after treatment 2.
|
Histological clearance is defined as the absence of detectable evidence of isSCC tumor cell nests by the central pathology reports |
Up to 63 days after treatment 2.
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Number of participants with clinical clearance of treated isSCC lesion
時間枠：Up to 63 days after treatment 2.
|
Complete Clinical Clearance will be measured by the Investigator and is defined as when there is no clinically visible lesion remaining at the site. |
Up to 63 days after treatment 2.
|
|
Local Skin Response Scale
時間枠：Up to 63 days after treatment 2
|
Observations and changes noted in the aesthetic appearance of the treated isSCC lesion site. |
Up to 63 days after treatment 2
|
協力者と研究者
捜査官
- 主任研究者：Mark S Nestor, MD, PhD、Center for Clinical and Cosmetic Research
研究記録日
主要日程の研究
研究開始 (実際)
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
- CCCR 02-2024
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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