Trial Outcomes & Findings for To Assess the Effectiveness of Multiple Dose, Multiple Concentrations of Qwo, for the Treatment of Mild to Moderate Cellulite. (NCT NCT05026216)
NCT ID: NCT05026216
Last Updated: 2026-05-28
Results Overview
The Investigator Global Aesthetic Improvement Scale (I-GAIS) is a 7-point scale ranging from -3 = very much worse to +3 = very much improved. Participants were considered responders if they had an I-GAIS score of +1 = improved or greater at Day 90.
COMPLETED
PHASE4
5 participants
Day 90
2026-05-28
Participant Flow
Patients who completed the EN3835-305 real-world study were recruited to participate in the IIR.
Participant milestones
| Measure |
Single-arm Study
Using CCH-ases on bilateral buttocks and thigh injections. No placebo being used.
|
|---|---|
|
Overall Study
STARTED
|
5
|
|
Overall Study
COMPLETED
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The analysis population includes participants who met all eligibility criteria and had evaluable baseline and post-baseline assessments. Differences between the numbers in the analysis population and the overall enrolled population may be due to exclusions such as screen failures, missing data, protocol deviations, or early withdrawal from the study.
Baseline characteristics by cohort
| Measure |
QWO Treatment
n=5 Participants
All enrolled participants who received treatment (N=5).
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=51 Participants • The analysis population includes participants who met all eligibility criteria and had evaluable baseline and post-baseline assessments. Differences between the numbers in the analysis population and the overall enrolled population may be due to exclusions such as screen failures, missing data, protocol deviations, or early withdrawal from the study.
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=51 Participants • The analysis population includes participants who met all eligibility criteria and had evaluable baseline and post-baseline assessments. Differences between the numbers in the analysis population and the overall enrolled population may be due to exclusions such as screen failures, missing data, protocol deviations, or early withdrawal from the study.
|
|
Age, Categorical
>=65 years
|
0 Participants
n=51 Participants • The analysis population includes participants who met all eligibility criteria and had evaluable baseline and post-baseline assessments. Differences between the numbers in the analysis population and the overall enrolled population may be due to exclusions such as screen failures, missing data, protocol deviations, or early withdrawal from the study.
|
|
Sex: Female, Male
Female
|
5 Participants
n=51 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=51 Participants
|
|
Race/Ethnicity, Customized
White/Not-Hispanic
|
5 Participants
n=51 Participants
|
PRIMARY outcome
Timeframe: Day 90The Investigator Global Aesthetic Improvement Scale (I-GAIS) is a 7-point scale ranging from -3 = very much worse to +3 = very much improved. Participants were considered responders if they had an I-GAIS score of +1 = improved or greater at Day 90.
Outcome measures
| Measure |
Single-arm Study
n=5 Participants
Using CCH-ases on bilateral buttocks and thigh injections. No placebo being used.
|
|---|---|
|
Proportion of Subjects With ≥1-point Improvement on Investigator Global Aesthetic Improvement Scale (I-GAIS) at Day 90 (Buttocks)
Responders (≥+1)
|
3 Participants
|
|
Proportion of Subjects With ≥1-point Improvement on Investigator Global Aesthetic Improvement Scale (I-GAIS) at Day 90 (Buttocks)
Non-responders (<+1)
|
2 Participants
|
PRIMARY outcome
Timeframe: Day 90The Investigator Global Aesthetic Improvement Scale (I-GAIS) is a 7-point scale ranging from -3 (very much worse) to +3 (very much improved). Responders were defined as subjects with a score of +1 (improved) or greater.
Outcome measures
| Measure |
Single-arm Study
n=5 Participants
Using CCH-ases on bilateral buttocks and thigh injections. No placebo being used.
|
|---|---|
|
Number of Participants With ≥1-Point Improvement on Investigator Global Aesthetic Improvement Scale (I-GAIS) at Day 90 (Thighs)
Non-responders (<+1)
|
1 Participants
|
|
Number of Participants With ≥1-Point Improvement on Investigator Global Aesthetic Improvement Scale (I-GAIS) at Day 90 (Thighs)
Responders (≥+1)
|
4 Participants
|
SECONDARY outcome
Timeframe: Days 22, 43, 90The Investigator Global Aesthetic Improvement Scale (I-GAIS) is a 7-point scale ranging from -3 (very much worse) to +3 (very much improved). Responders were defined as subjects with a score of +1 (improved) or greater.
Outcome measures
| Measure |
Single-arm Study
n=5 Participants
Using CCH-ases on bilateral buttocks and thigh injections. No placebo being used.
|
|---|---|
|
I-GAIS at Multiple Timepoints Buttocks
Day 22 · Responders (≥+1)
|
0 Participants
|
|
I-GAIS at Multiple Timepoints Buttocks
Day 22 · Non-responders (<+1)
|
5 Participants
|
|
I-GAIS at Multiple Timepoints Buttocks
Day 43 · Responders (≥+1)
|
1 Participants
|
|
I-GAIS at Multiple Timepoints Buttocks
Day 43 · Non-responders (<+1)
|
4 Participants
|
|
I-GAIS at Multiple Timepoints Buttocks
Day 90 · Responders (≥+1)
|
3 Participants
|
|
I-GAIS at Multiple Timepoints Buttocks
Day 90 · Non-responders (<+1)
|
2 Participants
|
SECONDARY outcome
Timeframe: Day 22, Day 43, Day 90The Investigator Global Aesthetic Improvement Scale (I-GAIS) is a 7-point scale ranging from -3 (very much worse) to +3 (very much improved). Responders were defined as subjects with a score of +1 (improved) or greater.
Outcome measures
| Measure |
Single-arm Study
n=5 Participants
Using CCH-ases on bilateral buttocks and thigh injections. No placebo being used.
|
|---|---|
|
I-GAIS at Multiple Timepoints Thighs
Day 22 · Responders (≥+1)
|
3 Participants
|
|
I-GAIS at Multiple Timepoints Thighs
Day 22 · Non-responders (<+1)
|
2 Participants
|
|
I-GAIS at Multiple Timepoints Thighs
Day 43 · Responders (≥+1)
|
2 Participants
|
|
I-GAIS at Multiple Timepoints Thighs
Day 43 · Non-responders (<+1)
|
3 Participants
|
|
I-GAIS at Multiple Timepoints Thighs
Day 90 · Responders (≥+1)
|
4 Participants
|
|
I-GAIS at Multiple Timepoints Thighs
Day 90 · Non-responders (<+1)
|
1 Participants
|
SECONDARY outcome
Timeframe: Day 90The Body-Q Appraisal of Cellulite is a patient-reported outcome ranging from 11 to 44, with higher scores indicating less bother from cellulite. Change from baseline to Day 90 was calculated for all participants.
Outcome measures
| Measure |
Single-arm Study
n=5 Participants
Using CCH-ases on bilateral buttocks and thigh injections. No placebo being used.
|
|---|---|
|
Mean Change From Baseline in Body-Q Appraisal of Cellulite at Day 90
|
11.6 Score (11-44 scale)
Standard Deviation 7.6
|
Adverse Events
Single-arm Study
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Single-arm Study
n=5 participants at risk
Using CCH-ases on bilateral buttocks and thigh injections. No placebo being used.
|
|---|---|
|
Skin and subcutaneous tissue disorders
Bruising
|
100.0%
5/5 • The following adverse events were reported by each subject post-treatment sessions, Day 1, Day 22 and Day 43.
Study participants were contacted within 72 hours post-treatment to assess for adverse events. Subject's self-reported adverse events such as bruising, pruritus, tenderness, edema, and hemosiderin staining.
|
|
General disorders
Edema
|
100.0%
5/5 • The following adverse events were reported by each subject post-treatment sessions, Day 1, Day 22 and Day 43.
Study participants were contacted within 72 hours post-treatment to assess for adverse events. Subject's self-reported adverse events such as bruising, pruritus, tenderness, edema, and hemosiderin staining.
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
40.0%
2/5 • The following adverse events were reported by each subject post-treatment sessions, Day 1, Day 22 and Day 43.
Study participants were contacted within 72 hours post-treatment to assess for adverse events. Subject's self-reported adverse events such as bruising, pruritus, tenderness, edema, and hemosiderin staining.
|
|
Skin and subcutaneous tissue disorders
Hemosiderin Staining
|
100.0%
5/5 • The following adverse events were reported by each subject post-treatment sessions, Day 1, Day 22 and Day 43.
Study participants were contacted within 72 hours post-treatment to assess for adverse events. Subject's self-reported adverse events such as bruising, pruritus, tenderness, edema, and hemosiderin staining.
|
|
General disorders
Tenderness
|
100.0%
5/5 • The following adverse events were reported by each subject post-treatment sessions, Day 1, Day 22 and Day 43.
Study participants were contacted within 72 hours post-treatment to assess for adverse events. Subject's self-reported adverse events such as bruising, pruritus, tenderness, edema, and hemosiderin staining.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place