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

A Randomized, Controlled Study Evaluating the Efficacy of a Skincare Routine and Acne Supplement or a Skincare Routine Alone on Improving Acne and Other Symptoms of PMS

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.

Study Overview

• Status: Completed
• Conditions: Acne; Premenstrual Syndrome
• Intervention / Treatment: Other: Skincare Routine; Dietary supplement: MINDBODYSKIN Supplement

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Santa Monica, California, United States, 90404
      • Citruslabs

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group One: Skincare Routine Only; Participants will follow instructions for the skincare routine only. Participants will complete the routine twice daily.	Other: Skincare Routine; Morning: 1. GENTLECLEAN - Wash with a quarter-sized amount of lukewarm water. Pat skin dry after. 2 CELLRENEW - Shake well, apply 2-3 pumps over the entire face, and massage into the skin 3. YOUARESUNSHINE - Apply generously and evenly as the last step in the skincare routine (before makeup). Night: VITAMINSCRUB - Wet your face with lukewarm water & apply a quarter-sized amount to wet palms. Lather until foamy. Gently massage the scrub using circular motions for 5-10 seconds. Rinse with lukewarm water and pat dry.; CLEARITY - Apply 2-3 pumps and massage into the skin avoiding the eye area. Let sit for 10-15 minutes. Do not wash off.; CELLRENEW - Shake well, apply 2-3 pumps over the entire face, and massage into the skin; HYDRAGLOW - Apply a dime-size amount of lotion and massage into the face
Active Comparator: Group Two: Skincare Routine + Supplement; Participants will follow instructions for the skincare routine AND will take a daily supplement.	Other: Skincare Routine; Morning: 1. GENTLECLEAN - Wash with a quarter-sized amount of lukewarm water. Pat skin dry after. 2 CELLRENEW - Shake well, apply 2-3 pumps over the entire face, and massage into the skin 3. YOUARESUNSHINE - Apply generously and evenly as the last step in the skincare routine (before makeup). Night: VITAMINSCRUB - Wet your face with lukewarm water & apply a quarter-sized amount to wet palms. Lather until foamy. Gently massage the scrub using circular motions for 5-10 seconds. Rinse with lukewarm water and pat dry.; CLEARITY - Apply 2-3 pumps and massage into the skin avoiding the eye area. Let sit for 10-15 minutes. Do not wash off.; CELLRENEW - Shake well, apply 2-3 pumps over the entire face, and massage into the skin; HYDRAGLOW - Apply a dime-size amount of lotion and massage into the face; Dietary supplement: MINDBODYSKIN Supplement; Participants will take 3 capsules daily with a meal. The MINDBODYSKIN acne supplement contains Vitamin A (6,100mcg per serving of 3 capsules), Vitamin B12, Vitamin B-5, 5-Hydroxytryptophan (5-HTP), 3,3'-Diindolymethane (DIM), a proprietary liver blend of milk thistle, dandelion extract and L-glutathione, turmeric root extract, a proprietary digestive blend of protease and betaine hydrochloride, and silicon dioxide.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Clearstem Skincare
• Collaborators: Citruslabs

Study record dates

Study Major Dates

• Study Start (Actual): June 30, 2023
• Primary Completion (Actual): December 30, 2023
• Study Completion (Actual): January 10, 2024

Study Registration Dates

• First Submitted: August 24, 2023
• First Submitted That Met QC Criteria: August 24, 2023
• First Posted (Actual): August 30, 2023

Study Record Updates

• Last Update Posted (Estimated): February 22, 2024
• Last Update Submitted That Met QC Criteria: February 20, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Menstruation Disturbances; Premenstrual Syndrome
• Other Study ID Numbers: 20282 (Other Identifier: Fred Hutch/University of Washington Cancer Consortium)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No