An RCT Evaluating the Efficacy of a Skincare Routine and Acne Supplement on Improving Acne and Other Symptoms of PMS

Not Applicable

Completed

• Conditions: Acne; Premenstrual Syndrome

• Registration Number: NCT06018168
• Lead Sponsor: Clearstem Skincare

Brief Summary

This study aims to evaluate the efficacy of the MINDBODYSKIN Hormonal Acne Supplement and a prescribed skincare routine of 6 products on facial acne and on symptoms of PMS, compared to a skincare routine of 6 products alone. This study will last for 24 weeks. The study will be conducted as a randomized, controlled trial in which participants will be split into two groups. Both will use the skincare routine, but one group will also take the MINDBODYSKIN supplement in combination with the skincare routine.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-06-30
• Study First Submitted: 2023-08-24
• Study First Submitted QC: 2023-08-24
• Study First Posted: 2023-08-30
• Primary Completion: 2023-12-30
• Study Completion: 2024-01-10
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-20
• Last Update Posted: 2024-02-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 60

Inclusion Criteria

Female 18 years of age or older Have regular acne Have any noticeable PMS symptoms like stress, bloating, mood swings, acne Be generally healthy (i.e. don't live with any uncontrolled chronic disease besides acne).

Have a body weight of >120 lbs.

Exclusion Criteria

Have any pre-existing conditions that would prevent participants from adhering to the protocol, including oncological and psychiatric disorders.

Be currently using any prescribed medications for their face Anyone with any known severe allergic reactions Women who are pregnant, breastfeeding or attempting to become pregnant Anyone unwilling to follow the study protocol

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Changes in participants perception of facial acne. [Baseline to Week 24]	24 weeks	Survey-based assessment (0-5 scale) of participants perception of changes to their facial acne.
Changes in facial acne. [Baseline to Week 24]	24 weeks	Participants will provide photos of their face for virtual skin grading by dermatologist.
Changes in blood serum levels of vitamin A. [Baseline to Week 24]	24 weeks	Participants will undergo blood draws to assess blood serum levels of vitamin A.

Secondary Outcome Measures

Name	Time	Method
Changes in symptoms of premenstrual syndrome (PMS). [Baseline to Week 24]	24 weeks	Survey-based assessment (0-5 scale) of common symptoms associated with PMS.

Trial Locations

Locations (1)

Citruslabs; 🇺🇸 Santa Monica, California, United States