AcneNCT06018168
An RCT Evaluating the Efficacy of a Skincare Routine and Acne Supplement on Improving Acne and Other Symptoms of PMS
A study testing Skincare Routine and MINDBODYSKIN Supplement in people with Acne and Premenstrual Syndrome, run by Clearstem Skincare at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Acne, Premenstrual Syndrome
- What is being tested?
- Skincare Routine and MINDBODYSKIN Supplement
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jun 2023to 10 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- Skincare Routine, MINDBODYSKIN Supplement
- Medical subject headings
- Acne Vulgaris, Premenstrual Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Skincare RoutineOther
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 SupplementDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| Group One: Skincare Routine Only | Active comparator | Participants will follow instructions for the skincare routine only. Participants will complete the routine twice daily. Receives: Other: Skincare Routine |
| Group Two: Skincare Routine + Supplement | Active comparator | Participants will follow instructions for the skincare routine AND will take a daily supplement. Receives: Other: Skincare Routine; Dietary Supplement: MINDBODYSKIN Supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in facial acne. [Baseline to Week 24]
Participants will provide photos of their face for virtual skin grading by dermatologist.
Measured: 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.
Measured: 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.
Measured: 24 weeks
Secondary outcomes (1)
Changes in symptoms of premenstrual syndrome (PMS). [Baseline to Week 24]
Survey-based assessment (0-5 scale) of common symptoms associated with PMS.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2023
- Study start30 Jun 2023
- Primary completion30 Dec 2023
- Study completion10 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AcneStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clearstem Skincare
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Citruslabs
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06018168
- Sponsor's protocol ID
- 20282
- Status last verified
- Feb 2024
- First submitted
- 24 Aug 2023
- Last updated
- 22 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06018168
- Acronym / sponsor ID
- 20282
- Conditions
- Acne, Premenstrual Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Clearstem SkincareIndustry (pharma, biotech, devices)
- Collaborators
- Citruslabs
- Study start
- 30 Jun 2023 (actual)
- Primary completion
- 30 Dec 2023 (actual)
- Study completion
- 10 Jan 2024 (actual)
- First posted
- 30 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Group One: Skincare Routine Only | Active comparator | Other: Skincare RoutineParticipants will follow instructions for the skincare routine only. Participants will complete the routine twice daily. |
| Group Two: Skincare Routine + Supplement | Active comparator | Other: Skincare Routine, Dietary Supplement: MINDBODYSKIN SupplementParticipants will follow instructions for the skincare routine AND will take a daily supplement. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Skincare RoutineMorning: 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 | Other | Group One: Skincare Routine Only, Group Two: Skincare Routine + Supplement |
| MINDBODYSKIN SupplementParticipants 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. | Dietary supplement | Group Two: Skincare Routine + Supplement |
Primary outcome
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.
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.
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.
1 secondary outcome
Changes in symptoms of premenstrual syndrome (PMS). [Baseline to Week 24]
Time frame: 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Skincare Routine and MINDBODYSKIN Supplement in people with Acne and Premenstrual Syndrome, run by Clearstem Skincare at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in facial acne. [Baseline to Week 24] (time frame: 24 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2024.