Assessing the Quality of Life of Patients With Rosacea

The study population consisted of 160 patients (123 women and 37 men) with rosacea, who agreed to participate in this study. Patients were qualified for the study among people visiting the cosmetic studio in Choroszcz in the period from June 2017 to November 2018, based on the diagnosis of a dermatologist and cosmetologist. The cosmetic intervention was performed using CAPILLARY REPAIR SERUM (30ml). Study participants completed self-reported questionnaire and standardized questionnaires.

Study Overview

• Status: Completed
• Conditions: Rosacea
• Intervention / Treatment: Behavioral: CAPILLARY REPAIR SERUM 30ml

• Study Type: Interventional
• Enrollment (Actual): 160
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Poland
  • Białystok, Poland, 15-089
    • Medical University of Bialystok

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• the inclusion criteria were: age ≥ 30 years,
• diagnosis of rosacea according to the criteria of the National Rosacea Society Expert Committee (NRSEC) from 2019,
• tolerance to the ingredients of the preparation used in the cosmetic intervention,
• lack of pregnancy and lactation,
• completion of a survey,
• signed informed consent

Exclusion Criteria:

• age < 30 years,
• patients with other facial skin diseases (e.g. acne, psoriasis, eczema),
• intolerance to the ingredients of the preparation used in the cosmetic treatment,
• patients with neuropsychiatric diseases, pregnancy, lactation,
• patients who did not sign informed consent to participate in the study
• did not complete the survey questionnaire.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Participants with rosacea

Behavioral: CAPILLARY REPAIR SERUM 30ml; Cosmetic procedures were performed on a group of patients after a cosmetic interview containing questions about contraindications to the procedure. The treatment was performed 3-times at 2-week intervals and consisted of cavitation peeling and sonophore-sis with an antioxidant preparation dedicated to vascular skin. The F-808 Skin Scrubber device was used for the treatment. After a month, the procedure was repeated. The stages of a cosmetologist's procedure during a cosmetic intervention were as follows: 1. make-up removal; 2. skin diagnostics, exclusion of contraindications, discussion of the procedure; 3. cavitation peeling - gentle skin cleansing using ultrasound; 4. applying an antioxidant cosmetic mixture (composition: rutin, horse chestnut and arnica extract, acerola, vitamin C, moisturizing complex of algae); 5. performing sonophoresis treatment; 6. applying the cream at the end; 7. discussion of indications for further care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Elements influenced on quality of life of participants with rosacea	The aim of the study was to assess whether antioxidant cosmetic procedures and selected lifestyle elements, especially dietary antioxidants have a significant impact on the quality of life of patients with rosacea.	17 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self-reported questionnaire	Author's questionnaire containing questions on sociodemographic status, anthropometic data, health behaviors, lifestyle, and information on rosacea.	17 months
Dietary Questionnaire	Energy of diet and nutrients intake were assessed using 3-day 24-h dietary recalls (two randomly selected weekdays and one weekend day) and computer program Diet 6.0.	17 months
The Physical Activity Questionnaire	The physical activity was assessed by a short version of the International Physical Activity Questionnaire (IPAQ).	17 months
DLQI (Dermatology Life Quality Index)	The assessment of quality of life in rosacea was carried out using the Polish version of standardized questionnaire DLQI (Dermatology Life Quality Index).	17 months
SWLS (Satisfaction With Life Scale)	The assessment of satisfaction with life in patients with rosacea was carried out using the Polish version of standardized questionnaire SWLS (Satisfaction With Life Scale).	17 months
BDI (Beck Depression Inventory)	The assessment of depression in patients with rosacea was carried out using the Polish version of standardized questionnaire BDI (Beck Depression Inventory).	17 months

Collaborators and Investigators

• Sponsor: Medical University of Bialystok
• Collaborators: University of Lomza
• Investigators: Principal Investigator: Małgorzata E Zujko, Dr., Medical Univeristy of Bialystok

Study record dates

Study Major Dates

• Study Start (Actual): May 8, 2017
• Primary Completion (Actual): November 30, 2018
• Study Completion (Actual): November 30, 2018

Study Registration Dates

• First Submitted: February 6, 2024
• First Submitted That Met QC Criteria: February 14, 2024
• First Posted (Estimated): February 21, 2024

Study Record Updates

• Last Update Posted (Estimated): February 21, 2024
• Last Update Submitted That Met QC Criteria: February 14, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: quality of life; lifestyle; cosmetics procedures; dietary antioxidants
• Additional Relevant MeSH Terms: Skin Diseases; Rosacea
• Other Study ID Numbers: LU20170508

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No