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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

Primary Purpose

Acne, Premenstrual Syndrome

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Skincare Routine
MINDBODYSKIN Supplement
Sponsored by
Clearstem Skincare
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Acne

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Citruslabs

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Group One: Skincare Routine Only

Group Two: Skincare Routine + Supplement

Arm Description

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

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

Outcomes

Primary Outcome Measures

Changes in facial acne. [Baseline to Week 24]
Participants will provide photos of their face for virtual skin grading by dermatologist.
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.
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.

Secondary Outcome Measures

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

Full Information

First Posted
August 24, 2023
Last Updated
August 24, 2023
Sponsor
Clearstem Skincare
Collaborators
Citruslabs
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1. Study Identification

Unique Protocol Identification Number
NCT06018168
Brief 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
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 30, 2023 (Actual)
Primary Completion Date
December 30, 2023 (Anticipated)
Study Completion Date
January 10, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Clearstem Skincare
Collaborators
Citruslabs

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acne, Premenstrual Syndrome

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group One: Skincare Routine Only
Arm Type
Active Comparator
Arm Description
Participants will follow instructions for the skincare routine only. Participants will complete the routine twice daily.
Arm Title
Group Two: Skincare Routine + Supplement
Arm Type
Active Comparator
Arm Description
Participants will follow instructions for the skincare routine AND will take a daily supplement.
Intervention Type
Other
Intervention Name(s)
Skincare Routine
Intervention Description
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
Intervention Type
Dietary Supplement
Intervention Name(s)
MINDBODYSKIN Supplement
Intervention Description
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 Outcome Measure Information:
Title
Changes in facial acne. [Baseline to Week 24]
Description
Participants will provide photos of their face for virtual skin grading by dermatologist.
Time Frame
24 weeks
Title
Changes in blood serum levels of vitamin A. [Baseline to Week 24]
Description
Participants will undergo blood draws to assess blood serum levels of vitamin A.
Time Frame
24 weeks
Title
Changes in participants perception of facial acne. [Baseline to Week 24]
Description
Survey-based assessment (0-5 scale) of participants perception of changes to their facial acne.
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Changes in symptoms of premenstrual syndrome (PMS). [Baseline to Week 24]
Description
Survey-based assessment (0-5 scale) of common symptoms associated with PMS.
Time Frame
24 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Citruslabs
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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