Edematous Skin Clinical Trial
Official title:
A Phase 2A, Open-Label Study Evaluating the Safety and Different Injection Techniques of CCH for the Treatment of Edematous Fibrosclerotic Panniculopathy (EFP)
| Verified date | August 2023 |
| Source | Endo Pharmaceuticals |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The study will evaluate the safety and effectiveness of different injection techniques of Collagenase Clostridium Histolyticum (CCH) for the treatment of adult women with mild, moderate or severe Edematous Fibrosclerotic Panniculopathy (commonly known as Cellulite).
| Status | Completed |
| Enrollment | 64 |
| Est. completion date | January 24, 2019 |
| Est. primary completion date | January 24, 2019 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Female |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: No participant will be assigned to treatment until all eligibility criteria have been satisfied. To qualify for the study a participant must: 1. Be able to provide voluntary written informed consent prior to the initiation of any study specific procedures per the policy of the governing Institutional Review Board (IRB)/Independent Ethics Committee (IEC). 2. Be female and at least 18 years of age at the time of consent. 3. Have evidence of cellulite in 2 bilateral treatment areas (defined as right and left buttocks or right and left posterolateral thighs) as assessed by the Investigator at the Screening visit, and fulfills the following requirements: 1. has a score of 2 (mild), 3 (moderate) or 4 (severe) as reported by the Investigator (CR-PCSS) in 2 treatment areas (two thighs or two buttocks) at the Screening Visit. 2. has at least 2 dimples from each treatment area that: - are isolated and separated by at least 5 centimeters (cm) from any other dimples. - score 2 or 3 on the Hexsel depression scale. - have dimple width: length ratio = 0.5. 4. Be willing to apply sunscreen to the dosing areas before each exposure to the sun while participating in the study (that is, screening through end of study). 5. Be judged to be in good health, based upon the results of a medical history, physical examination, and laboratory profile at screening. 6. Have a negative serum pregnancy test at the Screening Visit and negative urine pregnancy at Day 1 (before injection of study drug), be using an effective contraception method (for example, abstinence, intrauterine device, hormonal [estrogen/progestin] contraceptives, or double barrier control) for at least 1 menstrual cycle prior to study enrollment and through Day 71; or be menopausal defined as at least 12 months of amenorrhea in the absence of other biological or physiological causes (as determined by the Investigator), or be post-menopausal for at least 1 year, or be surgically sterile (hysterectomy, bilateral oophorectomy, bilateral tubal ligation). 7. Be willing and able to comply with all protocol required study visits and assessments. Exclusion Criteria: Participants who meet any of the following criteria will be excluded from the study: 1. Is pregnant or is intending to become pregnant during the study. 2. Is presently nursing/breastfeeding or providing breast milk. 3. Has any of the following systemic conditions: 1. Coagulation disorder. 2. Evidence or history of malignancy (other than excised basal-cell carcinoma) unless there has been no recurrence in at least 5 years. 3. History of keloidal scarring or abnormal wound healing. 4. Concurrent diseases or conditions that might interfere with the conduct of the study, confound the interpretation of the study results, or endanger the participant's well-being. 5. Evidence of clinically significant abnormalities on physical examination, vital signs, electrocardiogram (ECG), or clinical laboratory values. 4. Has any of the following local conditions in the areas to be treated: 1. History of lower extremity thrombosis or post-thrombosis syndrome. 2. Vascular disorder (for example, varicose veins, telangiectasia). 3. Inflammation or active infection. 4. Severe skin laxity, flaccidity, and/or sagging. 5. Active cutaneous alteration including rash, eczema, psoriasis, or skin cancer. 5. Has a tattoo located within 2 cm of the site of injection. 6. Requires anticoagulant or antiplatelet medication during the study or has received anticoagulant or antiplatelet medication (except for = 150 mg aspirin daily) within 7 days before injection of study drug. 7. Has used any of the following for the treatment of EFP on the area to be treated within the timelines identified below or intends to use any of the following at any time during the course of the study: 1. Liposuction within the treatment areas during the 12-month period before injection of study drug. 2. Injections (for example, mesotherapy); radiofrequency device treatments; laser treatment; or surgery (including subcision and/or powered subcision) within the treatment areas during the 12-month period before injection of study drug. 3. Any investigational treatment for EFP/cellulite on treatment areas during the 12-month period before the injection of study drug. 4. Endermologie® or similar treatments within the treatment areas during the 6-month period before injection of study drug. 5. Massage therapy within the treatment areas during the 3-month period before injection of study drug. 6. Creams (for example, Celluvera™, TriLastin®) to prevent or mitigate EFP within the treatment areas during the 2-week period before injection of study drug. 8. Has received an investigational drug or treatment within 30 days before injection of study drug. 9. Has a known systemic allergy to collagenase or any other excipient of study drug. 10. Has a history of drug or alcohol abuse. 11. Intends to initiate an intensive sport or exercise program during the study. 12. Intends to initiate a weight reduction program during the study. 13. Intends to use tanning spray or tanning booths during the study. 14. Has previously received any collagenase treatments (for example, Santyl® ointment and/or XIAFLEX/XIAPEX®). 15. Was a participant in a previous cellulite clinical trial of EN3835: AUX-CC-830, AUX-CC-831, EN3835-102, EN3835-104, EN3835-201, EN3835-202, EN3835-205, EN3835-302, or EN3835-303. 16. Any other condition(s) that, in the Investigator's opinion, might indicate the participant is unsuitable for the study. |
| Country | Name | City | State |
|---|---|---|---|
| United States | Endo Clinical Trial Site #1 | Coral Gables | Florida |
| United States | Endo Clinical Trial Site #5 | Miami | Florida |
| United States | Endo Clinical Trial Site #2 | New York | New York |
| United States | Endo Clinical Trial Site #3 | New York | New York |
| United States | Endo Clinical Trial Site #4 | New York | New York |
| Lead Sponsor | Collaborator |
|---|---|
| Endo Pharmaceuticals |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Aesthetic Appearance Improvement Likert Scores by Treatment Region at Day 22 | Aesthetic appearance improvement for each treatment area (buttocks or thighs) was assessed by a blinded central assessment, using a 5-point Likert scale with scores ranging from -1 to 3. Aesthetic improvement was scored as worse (-1), stayed the same (0), improved (1), much improved (2) and very much improved (3). The assessor evaluated the image at Day 22 in comparison with baseline and recorded the Likert score. Aesthetic appearance Likert scale scores were analyzed using linear mixed model with treatment arm, study visit, interaction of treatment arm and study visit as fixed effects. This model was fitted using the response for the average of left and right of treatment area (that is, average of left buttock and right buttock or average of left thigh and right thigh). | Day 22 | |
| Primary | Aesthetic Appearance Improvement Likert Scores by Treatment Region at Day 43 | Aesthetic appearance improvement for each treatment area (buttocks or thighs) was assessed by a blinded central assessment, using a 5-point Likert scale with scores ranging from -1 to 3. Aesthetic improvement was scored as worse (-1), stayed the same (0), improved (1), much improved (2) and very much improved (3). The assessor evaluated the image at Day 43 in comparison with baseline and recorded the Likert score. Aesthetic appearance Likert scale scores were analyzed using linear mixed model with treatment arm, study visit, interaction of treatment arm and study visit as fixed effects. This model was fitted using the response for the average of left and right of treatment area (that is, average of left buttock and right buttock or average of left thigh and right thigh). | Day 43 | |
| Primary | Aesthetic Appearance Improvement Likert Scores by Treatment Region at Day 71 | Aesthetic appearance improvement for each treatment area (buttocks or thighs) was assessed by a blinded central assessment, using a 5-point Likert scale with scores ranging from -1 to 3. Aesthetic improvement was scored as worse (-1), stayed the same (0), improved (1), much improved (2) and very much improved (3). The assessor evaluated the image at Day 71 in comparison with baseline and recorded the Likert score. Aesthetic appearance Likert scale scores were analyzed using linear mixed model with treatment arm, study visit, interaction of treatment arm and study visit as fixed effects. This model was fitted using the response for the average of left and right of treatment area (that is, average of left buttock and right buttock or average of left thigh and right thigh). | Day 71 | |
| Primary | Change From Baseline in Dimple Depth Depression (Hexsel CSS [B]) by Treatment Region at Day 22 | Dimple depth depression for each treatment area was assessed by the Investigator using the Hexsel Cellulite Severity Scale (B). Dimple Depth Depression of Hexsel Cellulite Severity Scale (B) was assessed and graded as: no depression (0), superficial depressions (1), medium depth depressions (2) and deep depressions (3). A negative change in Hexsel CSS (B) from baseline indicated an improvement in depression depth. Change from Baseline in dimple depth depression of Hexsel Cellulite Severity Scale (B) was analyzed using linear mixed model with treatment arm, study visits, interaction of treatment arm and study visit as fixed effect. This model was fitted using the response for the average of left and right of treatment areas (that is, average of left buttock and right buttock; average of left thigh and right thigh) | Baseline, Day 22 | |
| Primary | Change From Baseline in Dimple Depth Depression (Hexsel CSS [B]) by Treatment Region at Day 43 | Dimple depth depression for each treatment area was assessed by the Investigator using the Hexsel Cellulite Severity Scale (B). Dimple Depth Depression of Hexsel Cellulite Severity Scale (B) was assessed and graded as: no depression (0), superficial depressions (1), medium depth depressions (2) and deep depressions (3). A negative change in Hexsel CSS (B) from baseline indicated an improvement in depression depth. Change from Baseline in dimple depth depression of Hexsel Cellulite Severity Scale (B) was analyzed using linear mixed model with treatment arm, study visits, interaction of treatment arm and study visit as fixed effect. This model was fitted using the response for the average of left and right of treatment areas (that is, average of left buttock and right buttock; average of left thigh and right thigh) | Baseline, Day 43 | |
| Primary | Change From Baseline in Dimple Depth Depression (Hexsel CSS [B]) by Treatment Region at Day 71 | Dimple depth depression for each treatment area was assessed by the Investigator using the Hexsel Cellulite Severity Scale (B). Dimple Depth Depression of Hexsel Cellulite Severity Scale (B) was assessed and graded as: no depression (0), superficial depressions (1), medium depth depressions (2) and deep depressions (3). A negative change in Hexsel CSS (B) from baseline indicated an improvement in depression depth. Change from Baseline in dimple depth depression of Hexsel Cellulite Severity Scale (B) was analyzed using linear mixed model with treatment arm, study visits, interaction of treatment arm and study visit as fixed effect. This model was fitted using the response for the average of left and right of treatment areas (that is, average of left buttock and right buttock; average of left thigh and right thigh) | Baseline, Day 71 | |
| Secondary | Change From Baseline of Dimple Volume by Treatment Region | For each treated buttock and thigh, 4 dimple parameters including the maximum length (largest straight line distance across the dimple), maximum width (largest straight line distance perpendicular to the maximum length measurement), surface are, and volume (between the base of the dimple and an interpolated surface) of the target dimple were assessed. A negative change from Day 1 indicated an improvement. Volume of Dimple from Day 1 pre-marking was analyzed using linear mixed model with treatment arm, study visit, interaction of treatment arm and study visit as fixed effects. This model was fitted using the measurement for the average of left and right of treatment areas (that is, average of left buttock posterior and right buttock posterior; average of left thigh lateral, left thigh oblique, left thigh posterior, right thigh lateral, right thigh oblique, and right thigh posterior). | Baseline, Day 22, Day 43, and Day 71 |