A Real-Life, International, Observational Study Demonstrating The Efficacy Of A Cosmetic Emulsion In The Supportive Care Of Mild-To-Moderate Facial Acne

Figures & data

Table 1 Tolerance Evaluation Scale

Score	Definition	Description
0	Poor	Functional and/or objective symptoms that lead to discontinuation of product use
1	Moderate	Pronounced or persistent functional discomfort symptoms or objective symptoms that do not lead to discontinuation of product use
2	Good	Mild transient functional symptoms that do not lead to discontinuation of product use and no objective symptoms upon examination
3	Very good	No functional discomfort symptoms and no objective symptoms upon examination

Figure 1 Participant flow through the study.

Table 2 Demographics And Skin Characteristics At Inclusion In The Whole Study Population

Parameter	Whole Study Population At Inclusion (N=3955)
Gender, n (%)	N=3919
Male	1337 (34.1)
Female	2582 (65.9)
Age, years	N=3922
Mean±SD	18.4 ± 4.1
Median (min–max)	18 (11–49)
Age groups, n (%)	N=3955
12–18 years	1905 (48.2)
18–25 years	1707 (43.2)
≥25 years	343 (8.7)
Skin characteristics, n (%)^a	N=3680
Mixed	2437 (66.2)
Dry	156 (4.2)
Oily	1087 (29.5)
Skin phototype, n (%)^b	N= 3575
I	99 (2.8)
II	1324 (37.0)
III	1705 (47.7)
IV	396 (11.1)
V	36 (1.0)
VI	15 (0.4)

Notes: ^aSkin characteristics were described according to the investigator’s clinical evaluation. ^bSkin phototypes were defined according to the Fitzpatrick scale.

Table 3 Acne History And Clinical Characteristics At Inclusion In The Whole Study Population

Parameter		Whole Study Population (N=3955)
Family history of acne, n (%)
	Yes	1124 (29.2)
Duration of acne prior to inclusion, years	Mean±SD	3.3±3.3
	Median (min–max)	2 (0–28)
Facial acne, n (%)
Sites affected	Forehead	3009 (76.6)
	Cheeks	2863 (72.9)
	Mandibular region	2000 (50.9)
Type of facial acne	Mixed	2395 (61.6)
	Noninflammatory	668 (17.2)
	Superficial inflammatory	826 (21.2)
Secondary lesions	Presence of lesions	1641 (42.4)
	Atrophic scars	720 (47.4)
	Hypertrophic scars	103 (6.8)
	Hyperpigmented spots	1028 (67.3)
Other body sites affected by acne, n (%)
	Back	1254 (35.2)
	Neck	285 (8.1)
	Shoulders	754 (21.2)
	Chest	683 (19.2)
History of acne treatment prior to inclusion, n (%)
	Yes	2704 (70.2)
Number of acne treatments prior to inclusion		N=2704
	Mean±SD	2.3±1.3
	Median (min–max)	2 (1–9)
Type of prescription at inclusion, n (%)
	Addition to an ongoing treatment	380 (9.8)
	Initiation of treatment	1966 (50.9)
	Switched treatment	628 (16.2)
	Unchanged treatment	891 (23.1)
Acne treatment at inclusion^a, n (%)
Topical	Retinoids	763 (20.2)
	BPO	646 (17.1)
	Fixed combination retinoids+BPO	643 (17.0)
Systemic	Zinc	547 (13.8)
	Doxycycline	671 (17.7)

Notes: ^aTreatments prescribed to more than 10% of patients.

Abbreviation: BPO, benzoyl peroxide.

Figure 2 Severity of facial acne at inclusion and at follow-up after 2–3 months of use of the cosmetic product in combination with medical anti-acne therapy in the per protocol (PP) population (N=3746) and in the subpopulation of patients whose medical anti-acne treatment remained unchanged at inclusion (N=859). Severity was graded by the physician using the acne investigator’s global assessment (IGA) scale from 0 (clear) to 4 (severe). The percentages of patients with each score are shown.

Table 4 Acne Investigator’s Global Assessment And Objective Clinical Symptom Severity Scores In The Per Protocol Population And In The Subpopulation Of Patients Whose Medical Anti-Acne Treatment Remained Unchanged At Inclusion

Severity Scores Mean±SD	PP Population (N=3746)			Patients Whose Treatment Remained Unchanged (N=859)
	Inclusion	Follow-Up	% Change	Inclusion	Follow-Up	% Change
IGA	2.36±0.68	1.46±0.78	−37.4 ****	2.33±0.67	1.44±0.80	−38.3 ****
Noninflammatory lesions	1.55±0.65	0.93±0.59	−35.7****	1.54±0.64	0.93±0.63	−35.3****
Superficial inflammatory lesions	1.54±0.67	0.73±0.61	−50.0****	1.50±0.65	0.74±0.62	−47.0****
Hyperseborrhea	1.42±0.72	0.72±0.62	−43.8****	1.38±0.72	0.75±0.64	−40.6****
Skin irritation	0.75±0.77	0.32±0.54	−35.1****	0.76±0.75	0.29±0.53	−37.2****

Notes: ****P<0.0001 for the difference in severity scores between follow-up at the end of the 2–3 months of treatment and inclusion. Analyses were conducted using the Wilcoxon matched-pairs signed-rank test.

Abbreviations: PP, per protocol; IGA, investigator’s global assessment.

Figure 3 Global effectiveness at follow-up after 2–3 months of use of the cosmetic product in combination with medical anti-acne therapy in the per protocol (PP) population (N=3746) and in the subpopulation of patients whose medical anti-acne treatment remained unchanged at inclusion (N=859). Global effectiveness was measured by the physician with a 6-point scale from 1 (total disappearance) to 6 (aggravation). The percentages of patients with each score are shown.

Table 5 Global Cardiff Acne Disability Index (CADI) Score And CADI Score Category At Inclusion And At The End Of Treatment In The Per Protocol Population And In The Subpopulation Of Patients Whose Medical Anti-Acne Treatment Remained Unchanged At Inclusion

Global CADI Score	Inclusion	Follow-Up
PP population (N=3746)
Mean±SD	5.0 ± 3.0	2.7 ± 2.4
Median (min–max)	5.0 (0–15.0)	2.0 (0–13.0)
% change	−39.4****
Patients with treatment unchanged (N=859)
Mean±SD	5.1±3.0	2.7±2.2
Median (min–max)	5.0 (0–15.0)	3.0 (0–12.0)
% change	−38.3****
CADI score category, n (%) [95% CI]
0: Quality of life not affected by acne	186 (5.0) [4.3; 5.7]	829 (22.2) [20.9; 23.5]
1: Quality of life slightly affected by acne	2137 (57.1) [55.5; 58.7]	2485 (66.5) [64.9; 68.0]
2: Quality of life moderately affected by acne	1258 (33.6) [32.1; 35.2]	407 (10.9) [9.9; 11.9]
3: Quality of life severely affected by acne	159 (4.2) [3.7; 5.0]	17 (0.4) [0.3; 0.7]

Notes: ****P<0.0001 for the difference in global CADI score between follow-up at the end of the 2–3 months of treatment and inclusion. Analyses were carried out using the Student’s t-test.

Abbreviation: CADI, Cardiff acne disability index.