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

NCT06018168 | Completed

• 1 other identifier: 20282
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Acne; Premenstrual Syndrome

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Changes in symptoms of premenstrual syndrome (PMS). [Baseline to Week 24]

  24 weeks

Study Arms (2)

Group One: Skincare Routine Only

ACTIVE COMPARATOR

Participants will follow instructions for the skincare routine only. Participants will complete the routine twice daily.

Other: Skincare Routine

Group Two: Skincare Routine + Supplement

ACTIVE COMPARATOR

Participants will follow instructions for the skincare routine AND will take a daily supplement.

Other: Skincare Routine; Dietary Supplement: MINDBODYSKIN Supplement

Interventions

Skincare Routine OTHER

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: 1. 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. 2. CLEARITY - Apply 2-3 pumps and massage into the skin avoiding the eye area. Let sit for 10-15 minutes. Do not wash off. 3. CELLRENEW - Shake well, apply 2-3 pumps over the entire face, and massage into the skin 4. HYDRAGLOW - Apply a dime-size amount of lotion and massage into the face

Group One: Skincare Routine Only; Group Two: Skincare Routine + Supplement

MINDBODYSKIN Supplement DIETARY_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.

Group Two: Skincare Routine + Supplement

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Clearstem Skincare: lead
• Citruslabs: collaborator

Study Sites (1)

Citruslabs

Santa Monica, California, 90404, United States

Location

MeSH Terms

Conditions

Acne Vulgaris; Premenstrual Syndrome

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases; Menstruation Disturbances; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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 Record Dates

• First Submitted: August 24, 2023
• First Posted: August 30, 2023
• Study Start: June 30, 2023
• Primary Completion: December 30, 2023
• Study Completion: January 10, 2024
• Last Updated: February 22, 2024

Record last verified: 2024-02

Locations

US (1)