Assessing the Quality of Life of Patients With Rosacea

NCT06271135 | Completed

• 1 other identifier: LU20170508
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Rosacea

Keywords

quality of life; cosmetics procedures; lifestyle; dietary antioxidants

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Self-reported questionnaire

  17 months

• Dietary Questionnaire

  17 months

• The Physical Activity Questionnaire

  17 months

• DLQI (Dermatology Life Quality Index)

  17 months

• SWLS (Satisfaction With Life Scale)

  17 months

Study Arms (1)

Participants with rosacea

EXPERIMENTAL

Behavioral: CAPILLARY REPAIR SERUM 30ml

Interventions

CAPILLARY REPAIR SERUM 30ml BEHAVIORAL

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.

Participants with rosacea

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medical University of Bialystok: lead
• University of Lomza: collaborator

Study Sites (1)

Medical University of Bialystok

Bialystok, 15-089, Poland

Location

MeSH Terms

Conditions

Rosacea

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Małgorzata E Zujko, Dr.

  Medical Univeristy of Bialystok

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2024
• First Posted: February 21, 2024
• Study Start: May 8, 2017
• Primary Completion: November 30, 2018
• Study Completion: November 30, 2018
• Last Updated: February 21, 2024

Record last verified: 2024-02

Locations

PL (1)