Facial skin revitalization with CPM^®-HA20G: an effective and safe early intervention treatment

Figures & data

Figure 1 Treatment area and injection points for the left lower cheek. An identical injection pattern was used on the opposite cheek.

Figure 2 Overview of subject demographics and disposition.

Abbreviation: FAS, full analysis set.

Figure 3 Viscoelastic skin properties of the entire face (A) gross elasticity (R2; mean ± SD) measured before (day 0/baseline) and after three consecutive treatments with CPM^®-HA20G at day 0, week 4, and week 8 and all upcoming visits until week 28. (B) Skin fatigue (R9; mean ± SD) measured before (day 0/baseline) and after three consecutive treatments with CPM^®-HA20G at day 0, week 4, and week 8 and all upcoming visits until week 28. Due to a technical malfunction of the cutometer device, no test values could be obtained at week 36 visit. *p<0.05, **p<0.01, and ***p<0.001.

Table 1 Summary of cutometer values for the assessment of skin firmness (R0 values)

Study interval
	D0 N = 24	Week 4 N = 24	Week 8 N = 24	Week 12 N = 22	Week 24 N = 21	Week 28 N = 14
Skin firmness
Mean [mm]	0.10	0.11	0.14***	0.14***	0.08***	0.08**
Standard deviation	0.01	0.02	0.01	0.02	0.02	0.02

Notes:  **p<0.01, and ***p<0.001.

Figure 4 Skin hydration values of the entire face (A) Overall skin hydration values (mean ± SD) measured before (day 0/baseline) and after three consecutive treatments with CPM^®-HA20G at day 0, week 4, and week 8 and all upcoming visits until week 36. (B) Change of skin hydration values (mean ± SEM) from week 4 to week 36 visit. *p<0.05 and ***p<0.001.

Table 2 Subjects (n[%]) reporting satisfaction with various changes in skin texture over the study interval

Study interval
	Week 4 N = 23	Week 8 N = 24	Week 12 N = 22	Week 24 N = 21	Week 28 N = 21	Week 36 N = 21
Study interval
Hydration	5 (21.7)	17 (70.8)	17 (77.3)	16 (76.2)	15 (71.4)	11 (52.4)
Skin tone	3 (13.0)	14 (58.3)	12 (54.5)	12 (57.1)	13 (61.9)	12 (57.1)
De-stressing, refreshing effect	12 (52.2)	15 (62.5)	14 (63.6)	13 (61.9)	14 (66.7)	13 (61.9)
Softness and suppleness	11* (45.8)	16 (66.7)	16 (72.7)	13 (61.9)	15 (71.4)	12 (57.1)

Notes: N: Number of subjects with data available (ie, observed values); %: Percentage based on N (ie, observed values). ^*N=24 for softness and suppleness.

Figure 5 Skin radiation and skin roughness values of the entire face. (A) Change of skin radiation values (hemoglobin and melanin, each mean ± SEM) from week 4 to week 36 visit. (B) Change of skin roughness values (Ra, Rq, and Rz, each mean ± SEM) from week 4 to week 36 visit. *p<0.05, **p<0.01, and ***p<0.001.

Figure 6 Investigators Global Aesthetic Improvement Scale (GAIS) ratings. Improved = summary of ratings for improved, much improved, and very much improved scores.

Figure 7 Subject’s photographs at baseline and at weeks 9, 28, and 36 exhibiting overall skin quality improvements after treatment with CPM^®-HA20G.

Table 3 Number (n [%]) of subjects with treatment-emergent adverse events related to the CPM^®-HA20 device or its injection (Safety Evaluation Set, N=25). Eighty-four percent of the subjects experienced at least one related TEAE. All of them were mild or moderate in severity

Preferred term	Subjects with event	Number of events
	n (%)	m
Subjects with at least one related TEAE, number of related TEAEs	21 (84.0)	70
Injection-site hematoma	20 (80.0)	52
Injection-site pain	9 (36.0)	11
Injection-site pruritus	1 (4.0)	1
Injection-site swelling	6 (24.0)	6

Note: n: Number of subjects with data available; %: Percentage based on Safety Evaluation Set; m: Number of related TEAEs events.

Abbreviation: TEAE, treatment emergent adverse event.