Efficacy and safety of a fixed combination of benzoyl peroxide 4% and niacinamide 4% in a polyvinyl alcohol and perfluoro-ether polymer-based cream for the treatment of mild to moderate inflammatory rosacea

ISRCTN	ISRCTN17674262
DOI	https://doi.org/10.1186/ISRCTN17674262
Sponsor	Cantabria Labs Difacooper
Funder	Cantabria Labs Difacooper

Submission date: 02/12/2025
Registration date: 02/12/2025
Last edited: 02/12/2025

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Skin and Connective Tissue Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Massimo Milani
Public, Principal investigator, Scientific

Via Milano, 160
Caronno Pertusella
21042
Italy

Phone	+39 (0)280030205
Email	massimo.milani@difacooper.com

Study information

Primary study design	Interventional
Allocation	N/A: single arm study
Masking	Blinded (masking used)
Control	Uncontrolled
Assignment	Single
Purpose	Treatment
Scientific title	Efficacy and safety of a fixed combination of benzoyl peroxide 4% and niacinamide 4% in a polyvinyl alcohol and perfluoro-ether polymer-based cream for the treatment of mild to moderate inflammatory rosacea: a prospective assessor-blinded pilot trial
Study objectives
Ethics approval(s)	Approved 27/01/2025, Comitato Etico Locale Catania 1 (Via Santa Sofia,78, catania, 95123, Italy; +39 (0)954794036; celct1@policlinico.unict.it), ref: DIICA-2025
Health condition(s) or problem(s) studied	Mild to moderate inflammatory rosacea
Intervention	The patients were instructed to apply 0.25 ml of the tested product to the affected facial areas once daily at bedtime for 8 weeks. A mild, fragrance-free, hypoallergenic facial fluid cleanser, along with broad-spectrum sunscreen (SPF 50+) for the daily skincare routine were recommended.
Intervention type	Other
Primary outcome measure(s)	1. Overall treatment efficacy measured using IGA score at baseline, T1 (4 weeks), and T2 (8 weeks) 2. Erythema measured using a 4-point scale (from 0 = none, to 3 = severe erythema) at baseline, T1 (4 weeks), and T2 (8 weeks)
Key secondary outcome measure(s)	1. The evolution in the number of papule and pustular lesions measured by counting the number of inflammatory lesions at baseline, T1, and T2 2. Instrumental evaluation of erythema performed using VISIA-CR imaging at baseline, T1, and T2 3. Local tolerability of the product evaluated using a tolerability score (from score 0= very well tolerated, no pain/burning feeling and dryness feeling; to score 4= very intense pain/burning/dryness feeling) at T1 and T2
Completion date	01/10/2025

Eligibility

Participant type(s)
Age group	Mixed
Lower age limit	26 Years
Upper age limit	67 Years
Sex	All
Target sample size at registration	20
Key inclusion criteria	1. Diagnosis of mild to moderate inflammatory rosacea (≥ 5 papulopustular lesions), according to the Global ROSacea Consensus (ROSCO) panel (2019) 2. Wash-out period of at least 15 or 30 days for previous topical or systemic pharmacological agents for rosacea, respectively
Key exclusion criteria	1. Concomitant other inflammatory facial dermatoses 2. Known hypersensitivity or allergies to any components of the tested formulation 3. Pregnancy or breastfeeding
Date of first enrolment	27/01/2025
Date of final enrolment	01/07/2025

Locations

Countries of recruitment

Italy

Study participating centres

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Data sharing statement to be made available at a later date
IPD sharing plan

Editorial Notes

02/12/2025: Study's existence confirmed by the Comitato Etico Locale Catania 1.