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 of treating cellulite in a human patient, the method comprising: injecting into the affected collagenous septa network of the cellulite about 0.1 mg to about 5 mg per treatment session of a pharmaceutical formulation comprising a mixture of collagenase I and collagenase II obtained or derived from Clostridium histolyticum and having a specific activity of about 5,000 ABC units/mg to about 25,000 ABC units/mg, thereby treating the cellulite, wherein the treating results in a ≥1-point improvement from baseline in the affected area on a Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS) or a Patient-Reported Photonumeric Cellulite Severity Scale (PR-PCSS) at day 71 following the injecting.
2. The method of claim 1 , wherein the treating results in a ≥2-point improvement from baseline on both the CR-PCSS and the PR-PCSS at day 71 following the injecting.
3. The method of claim 1 , wherein the treating results in a ≥1-point improvement from baseline on both the CR-PCSS and the PR-PCSS at day 71 following the injecting.
4. The method of claim 1 , wherein the treating results in a ≥2-point improvement from baseline on either or both the CR-PCSS and the PR-PCSS at about 6 months or about 12 months following the injecting.
5. The method of claim 1 , wherein the treating results in a ≥2-point improvement from baseline on both the CR-PCSS and the PR-PCSS at about 22 days, about 43 days, about 90 days, or about 180 days after the injecting.
6. The method of claim 1 , wherein the collagenase I and collagenase II are present in a mass ratio of approximately 1:1.
7. The method of claim 6 , wherein the mixture has a specific activity of about 10,000 ABC units/0.58 mg and the method comprises injecting a total dose of about 0.84 mg per treatment session.
8. The method of claim 7 , wherein the total dose of about 0.84 mg per treatment session is administered in one of more injections.
9. The method of claim 7 , wherein the method comprises 12 injections of the pharmaceutical formulation.
10. The method of claim 1 , wherein the pharmaceutical formulation comprises collagenase I and collagenase II in a mass ratio of approximately 1:1 and having a specific activity of about 10,000 ABC units/mg and the method comprises injecting about 0.48 mg to about 0.84 mg of the pharmaceutical formulation.
11. The method of claim 10 , wherein the method comprises injecting the pharmaceutical formulation in one or more treatment sessions.
12. The method of claim 11 , wherein the method comprises injecting the pharmaceutical formulation in three treatment sessions that are each about 15-30 days apart.