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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06401889
Other study ID # MC220302
Secondary ID NCI-2024-0346822
Status Not yet recruiting
Phase
First received
Last updated
Start date June 1, 2024
Est. completion date June 2027

Study information

Verified date May 2024
Source Mayo Clinic
Contact Clinical Trials Referral Office
Phone 855-776-0015
Email mayocliniccancerstudies@mayo.edu
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study evaluates changes in skin quality and self-esteem among breast cancer patients who are initiating aromatase inhibitor therapy.


Description:

PRIMARY OBJECTIVES: I. Evaluate the incidence and severity of skin quality changes after initiation of Aromatase Inhibitor (AI) therapy in breast cancer (BC) survivors through use of Canfield Sciences VISIA-CA technology and facial skin assessment photography. II. Evaluate impact of AI therapy on patient-reported self-esteem and dermatology related life quality through validated patient reported outcome measures. III. Assess for objective improvements in skin quality measurements with VISIA-CA after skincare intervention with aesthetician consultation. IV. Measure changes in patient-reported self-esteem and dermatology related life quality following skincare intervention. OUTLINE: This is an observational study. Patients complete surveys/questionnaires, undergo skin measurement with the VISIA CA device, undergo facial skin photography, and attend consultations with an aesthetician on study.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 50
Est. completion date June 2027
Est. primary completion date June 2027
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria: - * Female = 18 years - Postmenopausal women suitable to receive aromatase inhibitor as per physician's discretion - Histologically confirmed adenocarcinoma of the breast stage 0-III with estrogen receptor (ER) and/or progesterone receptor (PR) positive per American Society of Clinical Oncology (ASCO)/ College of American Pathologists (CAP) guideline and any human epidermal growth factor receptor 2 (HER2) - Patients must not have received any prior chemotherapy or endocrine therapy for their current breast cancer. Patients who received tamoxifen or raloxifene or another agent for prevention of breast cancer may be included - Patients willing to avoid any facial procedures including facials, neurotoxin injections, fillers, or lasers during study period - Willing and able to provide consent Exclusion Criteria: - * Patients who have previously taken AIs - Patients using prescription tretinoin, neurotoxin injections, fillers, facial lasers, microneedling, or facials within 6 months of study consent

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Non-Interventional Study
Non-interventional study

Locations

Country Name City State
United States Mayo Clinic in Florida Jacksonville Florida

Sponsors (1)

Lead Sponsor Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Changes in skin quality Changes in skin quality measured as incidence and severity of skin quality changes using VISIA-CA technology (skin analysis imaging system) and facial skin assessment photography. Up to 6 months
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