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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-30

Study Completion Date

2024-01-10

Brief Summary

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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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Detailed Description

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Conditions

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Acne Premenstrual Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Group One: Skincare Routine Only

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

Group Type ACTIVE_COMPARATOR

Skincare Routine

Intervention Type 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 Two: Skincare Routine + Supplement

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

Group Type ACTIVE_COMPARATOR

Skincare Routine

Intervention Type 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

MINDBODYSKIN Supplement

Intervention Type 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.

Interventions

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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:

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

Intervention Type OTHER

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.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes