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Completed

NCT Number: NCT06018168

An RCT Evaluating the Efficacy of a Skincare Routine and Acne Supplement 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.

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Key information

Conditions

Acne Acne Vulgaris Acneiform Eruptions Menstruation Disturbances Pathologic Processes Pathological Conditions, Signs and Symptoms Premenstrual Syndrome Sebaceous Gland Diseases Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Citruslabs

Santa Monica, California, 90404, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Skincare Routine

Other

Morning:

  • 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

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.

Primary outcomes

  1. Changes in facial acne. [Baseline to Week 24]

    Time frame: 24 weeks

    Participants will provide photos of their face for virtual skin grading by dermatologist.

  2. Changes in blood serum levels of vitamin A. [Baseline to Week 24]

    Time frame: 24 weeks

    Participants will undergo blood draws to assess blood serum levels of vitamin A.

  3. Changes in participants perception of facial acne. [Baseline to Week 24]

    Time frame: 24 weeks

    Survey-based assessment (0-5 scale) of participants perception of changes to their facial acne.

Secondary outcomes

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

    Time frame: 24 weeks

    Survey-based assessment (0-5 scale) of common symptoms associated with PMS.

Sponsors and collaborators

Lead sponsor

Clearstem Skincare

Industry

Collaborators

  • Citruslabs

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
Aug 30, 2023
Registry last updated
Feb 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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