descriptive

Doctors use different strengths of the enzyme injection depending on whether they're treating the butt or thighs — weaker for thighs — and must use regular salt water, not special preserved water, to keep the enzyme working.

Scientific Claim

CCH-aaes is diluted to 0.23 mg/mL for buttocks and 0.046 mg/mL (1:5 dilution) for thighs in clinical practice, with normal saline preferred over bacteriostatic saline to preserve enzyme activity.

Original Statement

The CCH-aaes dilution used to treat the buttock (0.23 mg/mL) is different from that used for the thigh (0.046 mg/mL, a 1:5 dilution using normal saline, not bacteriostatic saline)... Laboratory data evaluating the activity, purity, and solubility of CCH-aaes have shown that bacteriostatic saline can cause up to a 40% loss in activity and aggregation of 5.3% of the protein, while normal saline does not have this effect.

Evidence Quality Assessment

Claim Status

appropriately stated

Study Design Support

Design supports claim

Appropriate Language Strength

definitive

Can make definitive causal claims

Assessment Explanation

The claim describes a standardized clinical technique, not a biological outcome. Expert consensus on dilution protocols is appropriately stated as a factual procedural recommendation based on manufacturer guidance and lab data cited.

Gold Standard Evidence Needed

According to GRADE and EBM methodology, here is what ideal scientific evidence would look like to definitively prove or disprove this specific claim, ordered from strongest to weakest evidence.

Randomized Controlled Trial
Level 1a

That 0.046 mg/mL dilution for thighs yields equivalent efficacy and safety to 0.23 mg/mL for buttocks, with no increased risk of adverse events.

What This Would Prove

That 0.046 mg/mL dilution for thighs yields equivalent efficacy and safety to 0.23 mg/mL for buttocks, with no increased risk of adverse events.

Ideal Study Design

A double-blind RCT comparing 3 sessions of 0.23 mg/mL CCH-aaes (buttocks) vs. 0.046 mg/mL (thighs) in 100 women, with primary outcome: CR-PCSS improvement at 12 weeks and secondary outcomes: bruising severity, pain scores, and enzyme activity via tissue biopsy.

Limitation: Cannot prove long-term durability or antibody response differences.

In Vitro Stability Study
Level 5
In Evidence

That bacteriostatic saline reduces CCH-aaes enzymatic activity by 40% compared to normal saline in human collagen substrates.

What This Would Prove

That bacteriostatic saline reduces CCH-aaes enzymatic activity by 40% compared to normal saline in human collagen substrates.

Ideal Study Design

An in vitro study exposing CCH-aaes to bacteriostatic saline vs. normal saline, measuring collagenase activity over 24 hours using fluorescently labeled type I/III collagen substrates and HPLC quantification of cleavage products.

Limitation: Does not reflect in vivo tissue penetration or immune response.

Cross-Sectional Survey
Level 4

The prevalence and consistency of dilution practices among clinicians treating cellulite with CCH-aaes.

What This Would Prove

The prevalence and consistency of dilution practices among clinicians treating cellulite with CCH-aaes.

Ideal Study Design

A national survey of 200+ aesthetic practitioners using CCH-aaes, asking about dilution protocols, diluent choice, and reasons for selection, with validation via product vial labeling inspection.

Limitation: Cannot determine clinical outcomes associated with different dilutions.

Evidence from Studies

No evidence studies found yet.