Evaluation of the occurrence and severity of acne after insertion of a levonorgestrel Intrauterine Device compared to the Copper IUD a prospective study

• Grant number: 24/08438-0
• Support Opportunities: Scholarships in Brazil - Scientific Initiation
• Start date: July 01, 2024
• End date: June 30, 2025
• Field of knowledge: Health Sciences - Medicine
• Principal Investigator: Eneida Maria Boteon Schmitt
• Grantee: Raquel Imperio Marques
• Host Institution: Faculdade de Medicina (FMB). Universidade Estadual Paulista (UNESP). Campus de Botucatu. Botucatu , SP, Brazil

Abstract

Long-acting reversible contraceptives (LARCs) are known for providing highly effective contraception. LARCs include intrauterine devices (hormonal and non-hormonal) and subdermal implants. The intrauterine device (IUD) is a contraceptive method that can be hormonal (LNG-IUS 20), which contains progesterone, or non-hormonal, with a stem coated with a layer of copper (Cu-IUD). Levonorgestrel, a synthetic progesterone present in the LNG-IUS 20, is a derivative of methyltestosterone. When administered orally, it has been associated with acne, with a reported incidence between 5% and 20%. In contrast, given its localized effect, the LNG-IUS 20 produces lower systemic levels compared to the oral route and is therefore believed to have fewer adverse effects. Acne vulgaris is not only a problem of adolescence but is also a prevalent complaint among adults, especially women. This study aims to evaluate the occurrence of acne vulgaris in adult women, aged 25 to 50 years, after the insertion of the LNG-IUS 20 or Cu-IUD for contraception. This is a non-randomized clinical trial. The intervention group will be considered the LNG-IUS 20 users, and the control group will be the Cu-IUD users. Sixty patients will be included, 30 in each group. Data will be collected through face-to-face interviews on the date of device insertion, including a dermatological examination and standardized facial photographs of the patients. These will be reassessed in the same way after 3 and 6 months of the contraceptive method's introduction. Acne lesion photographs will be evaluated by an experienced dermatologist who will be blinded to the patient's group. The prevalence of acne complaints will be the primary outcome of the study and will be compared between groups using generalized linear models. The main independent variable will be the type of IUD used. The secondary outcome will be the severity of acne at the end of the follow-up.