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Description of health-related quality of life and evaluation of the use of Cosmetic Camouflage in patients with Systemic Lupus Erythematosus and skin scars caused by the disease

Impact of the use of Cosmetic Camouflage on health-related quality of life in patients with Systemic Lupus Erythematosus and cutaneous manifestations

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-59h84g
Enrollment
Unknown
Registered
2018-05-11
Start date
2015-10-01
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Disseminated [systemic] lupus erythematosus

Interventions

Intervention Group: 33 patients will respond to quality of life, self-esteem and anxiety and depression questionnaires
after the answers, will receive training for the use of cosmetic camouflage (makeup for clinical use) under the scars of cutaneous manifestations of the disease. After 12 weeks they will return to res
Other

Sponsors

Hospital das Clínicas da Universidade Federal de Minas Gerais
Lead Sponsor
Santa Casa de Misericórdia de Belo Horizonte
Collaborator

Eligibility

Sex/Gender
Female
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: Age greater than or equal to eighteen years; signature of the Informed Consent Term (TCLE);presence of scars of cutaneous manifestations of the disease on the face

Exclusion criteria

Exclusion criteria: Moderate to severe disease activity at the time of inclusion or during the study (defined as SLEDAI 2k-Modified> 4, excluding cutaneous manifestations); not understanding the questionnaires; patients who have initiated psychological and / or psychiatric treatment, with or without medication, within four weeks prior to the start of the study and during its execution or who have undergone treatment modification during the study; development of allergic reaction to the cosmetic product used; moderate to severe cutaneous activity assessed by a rheumatologist

Design outcomes

Primary

MeasureTime frame
Presentation of the expected outcome 1: improvement of health-related quality of life; and to verify the expected outcome by means of minimum variation in the SLEQOL quality of life questionnaires of 25 points and the DLQI of 3.3 points in the pre and post intervention measurements;Presentation of the expected outcome 2: improvement of self-esteem; and to verify the expected outcome by means of minimum variation in the Rosenberg self-esteem Scale scores of at least 5% in the pre- and post-intervention measurements;Presentation of expected outcome 3: improvement of anxiety and depression rates; and to verify the expected outcome by means of reduction in the HAD Scale of anxiety and depression below 7 in the pre- and post-intervention measurements

Secondary

MeasureTime frame
Presentation of the expected secondary outcome 1: describe the quality of life related to health; and to verify the expected outcome by means of the descriptive statistical analysis of the indices obtained in the SLEQOL and DLQI quality of life questionnaires at the time of inclusion;Presentation of the expected secondary outcome 2: describe the self-esteem; and verify the expected outcome by means of the descriptive statistical analysis of the indices obtained in the self-esteem questionnaire (Rosenberg's self-esteem scale) at the time of inclusion;Presentation of the expected secondary outcome 3: describe the anxiety / depression indexes in these patients; and to verify the expected outcome by means of the descriptive statistical analysis of the indices obtained in the anxiety / depression questionnaire (HAD anxiety and depression scale) at the time of inclusion

Countries

Brazil

Contacts

Public ContactFernando Afranio Oliveira

Faculdade de Medicina da Universidade Federal de Minas Gerais

fafranio@hotmail.com+55031988984478

Outcome results

None listed

Source: REBEC (via WHO ICTRP)