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Completed

NCT Number: NCT06271135

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.

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Key information

Age range

30 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical University of Bialystok

Bialystok, 15-089, Poland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Elements influenced on quality of life of participants with rosacea

    Time frame: 17 months

    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.

Secondary outcomes

  1. Self-reported questionnaire

    Time frame: 17 months

    Author's questionnaire containing questions on sociodemographic status, anthropometic data, health behaviors, lifestyle, and information on rosacea.

  2. Dietary Questionnaire

    Time frame: 17 months

    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.

  3. The Physical Activity Questionnaire

    Time frame: 17 months

    The physical activity was assessed by a short version of the International Physical Activity Questionnaire (IPAQ).

  4. DLQI (Dermatology Life Quality Index)

    Time frame: 17 months

    The assessment of quality of life in rosacea was carried out using the Polish version of standardized questionnaire DLQI (Dermatology Life Quality Index).

  5. SWLS (Satisfaction With Life Scale)

    Time frame: 17 months

    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).

  6. BDI (Beck Depression Inventory)

    Time frame: 17 months

    The assessment of depression in patients with rosacea was carried out using the Polish version of standardized questionnaire BDI (Beck Depression Inventory).

Sponsors and collaborators

Lead sponsor

Medical University of Bialystok

Other

Collaborators

  • University of Lomza

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Feb 21, 2024
Registry last updated
Feb 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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