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

Acne Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06018168
• Other study ID #: 20282
• Status: Completed
• Phase: N/A
• Start date: June 30, 2023
• Est. completion date: January 10, 2024

Study information

• Verified date: February 2024
• Source: Clearstem Skincare
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: January 10, 2024
• Est. primary completion date: December 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acne
• Premenstrual Syndrome

Intervention

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.

Locations

Country	Name	City	State
United States	Citruslabs	Santa Monica	California

Sponsors (2)

Lead Sponsor	Collaborator
Clearstem Skincare	Citruslabs

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in facial acne. [Baseline to Week 24]	Participants will provide photos of their face for virtual skin grading by dermatologist.	24 weeks
Primary	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
Primary	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	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