Method of assessing and treating cellulite
The present disclosure relates to a method for rating the severity of cellulite on a thigh or buttock in a human subject by utilizing a photonumeric scale that provides reliable results from physician-to-physician and patient-to-patient.
1. A method for rating the severity of, and treating, cellulite in an affected area of a human subject, the method comprising:
rating the severity of the subject's cellulite using a validated photonumeric scale comprising 3 to 10 images showing an affected area of one or more example patients, the affected area in each of the 3 to 10 images of the example patients corresponding to the location of the affected area of the human subject, wherein each of the 3 to 10 images has a different severity rating comprising a numerical value, description, or both, the severity rating being based on a combination of two or more characteristics of cellulite selected from the group consisting of the number, depth, size, width, diameter, and distribution of dimples, wherein the photonumeric scale was validated using a test-retest reliability analysis; and
injecting into the affected area a pharmaceutical formulation comprising a mixture of collagenase I and collagenase II obtained or derived from Clostridium histolyticum to thereby treat the cellulite.
2. The method of claim 1 , wherein the affected area is the thigh or the buttock.
3. The method of claim 1 , wherein the photonumeric scale produces a consistency among evaluators of at least 50%.
4. The method of claim 1 , wherein the scale is a CR-PCSS scale that, when employed by a plurality of clinicians, at least 40% of the clinicians give the patient's area of cellulite the same cellulite severity rating from when the patients were screened and Day 1 pre-treatment.
5. The method of claim 4 , wherein the clinicians provide the same rating in about 50%, or about 60%, or about 70%, or about 80%, or about 90%, or about 100% of patients.
6. The method of claim 1 , wherein the scale is a CR-PCSS and a PR-PCSS that are employed to assess cellulite severity by an evaluation method selected from live assessment, by viewing digital images of the cellulite area, by viewing photographs of the cellulite area, and by viewing mirrored images of the cellulite area.
7. The method of claim 1 , wherein the scale comprises a CR-PCSS scale.
8. The method of claim 1 , wherein the scale comprises a PR-PCSS scale.
9. The method of claim 1 , wherein the scale comprises both a CR-PCSS scale and a PR-PCSS scale.
10. The method of claim 1 , wherein the photonumeric scale comprises an image showing an affected area having no evident cellulite and an image showing an affected area having severe cellulite.
11. The method of claim 10 , wherein the image showing an affected area having no evident cellulite has a numerical value that is lower than the image showing an affected area having severe cellulite.
12. The method of claim 11 , wherein the image showing an affected area having no evident cellulite:
has a numerical value of 0; and/or
contains no dimples, no depressions, no raised areas, or any combination thereof.
13. The method of claim 12 , wherein the image showing an affected area having severe cellulite:
has a numerical value of 4; and/or
contains numerous deep dimples or ridges that cover most of the affected area, numerous undulations with alternating areas of protuberances and depressions of severe depth, or both.
14. A method for treating and improving evaluator consistency in rating the severity of cellulite in a buttock or a thigh of a human subject, the method comprising:
providing a validated photonumeric scale comprising 3 to 10 images showing an affected area of one or more example patients, the affected area in each of the 3 to 10 images of the example patients corresponding to the location of the affected area of the human subject, wherein each of the 3 to 10 images has a different severity rating comprising a numerical value, description, or both, the severity rating being based on a combination of two or more characteristics of cellulite selected from the group consisting of the number, depth, size, width, diameter, and distribution of dimples, wherein the photonumeric scale was validated using a test-retest reliability analysis;
comparing the scale to a corresponding characteristic of cellulite from a subject to obtain a rating of the level of severity of the cellulite of the subject; and
injecting into the affected area a pharmaceutical formulation comprising a mixture of collagenase I and collagenase II obtained or derived from Clostridium histolyticum to thereby treat the cellulite.
15. The method of claim 14 , wherein the scale comprises a CR-PCSS scale.
16. The method of claim 14 , wherein the scale comprises a PR-PCSS scale.
17. The method of claim 14 , wherein the scale comprises both a CR-PCSS scale and a PR-PCSS scale.
18. The method of claim 14 , wherein the consistency among a plurality of evaluators is at least 50%.
19. The method of claim 14 , wherein the consistency among a plurality of evaluators is about 50%, or about 60%, or about 70%, or about 80%, or about 90%, or about 100%.