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NCT Number: NCT06401889

Enhancing Skin Appearance and Quality of Life in Breast Cancer Survivors on Aromatase Inhibitor Therapy

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

Recruiting

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Non-Interventional Study

Other

Non-interventional study

Primary outcomes

  1. Changes in skin quality

    Time frame: Up to 6 months

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Clinical Trials Referral Office

CONTACT

[email protected]

855-776-0015

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
May 7, 2024
Registry last updated
May 19, 2026

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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