RosaceaNCT06271135
Assessing the Quality of Life of Patients With Rosacea
A study testing CAPILLARY REPAIR SERUM 30ml in people with Rosacea, run by Medical University of Bialystok at 1 site in Poland.
Trial 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… Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Rosacea
- What is being tested?
- CAPILLARY REPAIR SERUM 30ml
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 sitePoland
- Study dates
- 8 May 2017to 30 Nov 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- CAPILLARY REPAIR SERUM 30ml
- Keywords
- quality of life, cosmetics procedures, lifestyle, dietary antioxidants
- Medical subject headings
- Rosacea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAPILLARY REPAIR SERUM 30mlBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Participants with rosacea | Experimental | Not described Receives: Behavioral: CAPILLARY REPAIR SERUM 30ml |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 17 months
Secondary outcomes (6)
Self-reported questionnaire
Author's questionnaire containing questions on sociodemographic status, anthropometic data, health behaviors, lifestyle, and information on rosacea.
Measured: 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.
Measured: 17 months
The Physical Activity Questionnaire
The physical activity was assessed by a short version of the International Physical Activity Questionnaire (IPAQ).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 17 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2024
- Study start8 May 2017
- Primary completion30 Nov 2018
- Study completion30 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RosaceaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Bialystok
- Sponsor type
- University, hospital or other
- Collaborators
- University of Lomza
- Responsible party
- Sponsor
- Investigators
- Małgorzata E Zujko, Dr., Principal investigator, Medical Univeristy of Bialystok
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06271135
- Sponsor's protocol ID
- LU20170508
- Status last verified
- Feb 2024
- First submitted
- 6 Feb 2024
- Last updated
- 21 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Quality of Life of Patients With Rosacea
- ClinicalTrials.gov ID
- NCT06271135
- Acronym / sponsor ID
- LU20170508
- Conditions
- Rosacea
- Keywords
- quality of life, cosmetics procedures, lifestyle, dietary antioxidants
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Medical University of BialystokUniversity, hospital or other
- Collaborators
- University of Lomza
- Study start
- 8 May 2017 (actual)
- Primary completion
- 30 Nov 2018 (actual)
- Study completion
- 30 Nov 2018 (actual)
- First posted
- 21 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants with rosacea | Experimental | Behavioral: CAPILLARY REPAIR SERUM 30ml |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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,
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CAPILLARY REPAIR SERUM 30mlCosmetic 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. | Behavioural | Participants with rosacea |
Primary outcome
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.
6 secondary outcomes
Self-reported questionnaire
Time frame: 17 months
Dietary Questionnaire
Time frame: 17 months
The Physical Activity Questionnaire
Time frame: 17 months
DLQI (Dermatology Life Quality Index)
Time frame: 17 months
SWLS (Satisfaction With Life Scale)
Time frame: 17 months
BDI (Beck Depression Inventory)
Time frame: 17 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Małgorzata E Zujko, Dr. principal investigator
Medical Univeristy of Bialystok
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CAPILLARY REPAIR SERUM 30ml in people with Rosacea, run by Medical University of Bialystok at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Elements influenced on quality of life of participants with rosacea (time frame: 17 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2024.