A novel azelaic acid formulation for the topical treatment of inflammatory rosacea: A multicentre, prospective clinical trial.
azelaic acid
rosacea
topical treatments
Journal
Journal of cosmetic dermatology
ISSN: 1473-2165
Titre abrégé: J Cosmet Dermatol
Pays: England
ID NLM: 101130964
Informations de publication
Date de publication:
Apr 2021
Apr 2021
Historique:
accepted:
16
03
2021
entrez:
2
5
2021
pubmed:
3
5
2021
medline:
15
5
2021
Statut:
ppublish
Résumé
Topical azelaic acid (AzA) is a common treatment for mild/moderate inflammatory rosacea. To assess the efficacy and tolerability of a novel formulation cream containing 15% AzA (anti-inflammatory/anti-oxidant/anti-microbial agent) combined with 1% dihydroavenanthramide D (anti-inflammatory/anti-itch) in inflammatory rosacea using clinical/instrumental evaluation. In this multicentre, prospective, open-label trial, 45 patients with mild/moderate inflammatory rosacea enrolled at the Dermatology Clinic of the University of Catania, Naples, and Rome (Italy) were instructed to apply the cream twice daily for 8 weeks. Clinical evaluation was performed at baseline (T0) and at 8 weeks (T1) by (1) Investigator Global Assessment (IGA) score based on a 5-point scale (from 0 = clear/no erythema/papules/pustules to 4 = severe erythema/several papules/pustules) and (2) inflammatory lesions count. Instrumental evaluation of erythema degree was performed by erythema-directed digital photography (EDDP) by a 5-point scale (from 0 = no redness to 4 = severe redness) at all time points. Tolerability was assessed by a self-administered questionnaire at 8 weeks. Statistical analysis was performed using SAS version 9. Forty-four patients completed the study. At week 8, a significant decrease in baseline of IGA scores [median from 3 (T0) to 1 (T1)] and inflammatory lesions count [median from 8 (T0) to 1 (T1)] was recorded along with a significant reduction of erythema scores [median from 2 (T0) to 1 (T1)]. No relevant side effects were recorded. Our results suggest that this new non-irritating product represents a valid therapeutic option for mild/moderate inflammatory rosacea, and EDDP is able to provide a more defined evaluation of erythema changes.
Sections du résumé
BACKGROUND
BACKGROUND
Topical azelaic acid (AzA) is a common treatment for mild/moderate inflammatory rosacea.
AIMS
OBJECTIVE
To assess the efficacy and tolerability of a novel formulation cream containing 15% AzA (anti-inflammatory/anti-oxidant/anti-microbial agent) combined with 1% dihydroavenanthramide D (anti-inflammatory/anti-itch) in inflammatory rosacea using clinical/instrumental evaluation.
METHODS
METHODS
In this multicentre, prospective, open-label trial, 45 patients with mild/moderate inflammatory rosacea enrolled at the Dermatology Clinic of the University of Catania, Naples, and Rome (Italy) were instructed to apply the cream twice daily for 8 weeks. Clinical evaluation was performed at baseline (T0) and at 8 weeks (T1) by (1) Investigator Global Assessment (IGA) score based on a 5-point scale (from 0 = clear/no erythema/papules/pustules to 4 = severe erythema/several papules/pustules) and (2) inflammatory lesions count. Instrumental evaluation of erythema degree was performed by erythema-directed digital photography (EDDP) by a 5-point scale (from 0 = no redness to 4 = severe redness) at all time points. Tolerability was assessed by a self-administered questionnaire at 8 weeks. Statistical analysis was performed using SAS version 9.
RESULTS
RESULTS
Forty-four patients completed the study. At week 8, a significant decrease in baseline of IGA scores [median from 3 (T0) to 1 (T1)] and inflammatory lesions count [median from 8 (T0) to 1 (T1)] was recorded along with a significant reduction of erythema scores [median from 2 (T0) to 1 (T1)]. No relevant side effects were recorded.
CONCLUSIONS
CONCLUSIONS
Our results suggest that this new non-irritating product represents a valid therapeutic option for mild/moderate inflammatory rosacea, and EDDP is able to provide a more defined evaluation of erythema changes.
Identifiants
pubmed: 33934475
doi: 10.1111/jocd.14098
pmc: PMC8252084
doi:
Substances chimiques
Dermatologic Agents
0
Dicarboxylic Acids
0
azelaic acid
F2VW3D43YT
Types de publication
Clinical Trial
Journal Article
Multicenter Study
Langues
eng
Sous-ensembles de citation
IM
Pagination
28-31Informations de copyright
© 2021 The Authors. Journal of Cosmetic Dermatology published by Wiley Periodicals LLC.
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