Conditions: Characteristics of Subcutaneous Tissue
Allocation: NON_RANDOMIZED | Intervention model: PARALLEL
Enrollment: 10
Healthy volunteers: yes

Brief summary:
To evaluate the histopathology of subcutaneous tissue isolated after single or multiple Collagenase Clostridium Histolyticum (CCH) injection techniques in adult female participants undergoing abdominoplasty.

Detailed description:

Arms:
arm 1: Participants were administered 0.07 milligrams (mg) CCH subcutaneously using a single injection technique.

Each participant had 2 marked areas (Area 1 and Area 2) of the abdomen selected for injection. Area 1 was administered CCH on Days -43 and -22. Area 2 was administered CCH on Day -14. arm 2: Participants were administered 0.07 mg CCH subcutaneously using a single injection technique. Each participant had 2 marked areas (Area 1 and Area 2) of the abdomen selected for injection. Area 1 was administered CCH on Days -24 and -3. Area 2 was administered CCH on Day -3. arm 3: Participants were administered 0.07 mg CCH subcutaneously using a single injection technique. Each participant had 2 marked areas (Area 1 and Area 2) of the abdomen selected for injection. Area 1 was administered CCH on Days -22 and -1. Area 2 was administered CCH on Day -1. arm 4: Participants were administered 0.0653 mg CCH subcutaneously using a multiple injection technique.

Each participant had 2 marked areas (Area 1 and Area 2) of the abdomen selected for injection. Area 1 was administered CCH on Days -43 and -22. Area 2 was administered CCH on Day -14. arm 5: Participants were administered 0.0653 mg CCH subcutaneously using a multiple injection technique.

Each participant had 2 marked areas (Area 1 and Area 2) of the abdomen selected for injection. Area 1 was administered CCH on Days -24 and -3. Area 2 was administered CCH on Day -3. arm 6: Participants were administered 0.0653 mg CCH subcutaneously using a multiple injection technique.

Each participant had 2 marked areas (Area 1 and Area 2) of the abdomen selected for injection. Area 1 was administered CCH on Days -22 and -1. Area 2 was administered CCH on Day -1.

Interventions: intervention 1: Collagenase Clostridium Histolyticum Single Injection Technique intervention 2: Collagenase Clostridium Histolyticum Multiple Injection Technique
Intervention descriptions: intervention 1: CCH was injected subcutaneously using a single injection technique. Dose per each administration was 0.07 mg. intervention 2: CCH was injected subcutaneously using a multiple injection technique. Dose per each administration was 0.0653 mg.

Protocol document:
Prot_000.pdf: 















































































































SAP_001.pdf: