xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06018168</url>
    </required_header>
    <id_info>
      <org_study_id>20282</org_study_id>
      <nct_id>NCT06018168</nct_id>
    </id_info>
    <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</brief_title>
    <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</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Clearstem Skincare</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Citruslabs</agency>
        <agency_class>Industry</agency_class>
      </collaborator>
    </sponsors>
    <source>Clearstem Skincare</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        This study aims to evaluate the efficacy of the MINDBODYSKIN Hormonal Acne Supplement and a&#xD;
        prescribed skincare routine of 6 products on facial acne and on symptoms of PMS, compared to&#xD;
        a skincare routine of 6 products alone. This study will last for 24 weeks. The study will be&#xD;
        conducted as a randomized, controlled trial in which participants will be split into two&#xD;
        groups. Both will use the skincare routine, but one group will also take the MINDBODYSKIN&#xD;
        supplement in combination with the skincare routine.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Active, not recruiting</overall_status>
    <start_date type="Actual">June 30, 2023</start_date>
    <completion_date type="Anticipated">January 10, 2024</completion_date>
    <primary_completion_date type="Anticipated">December 30, 2023</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <intervention_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.</intervention_model_description>
      <primary_purpose>Other</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Changes in facial acne. [Baseline to Week 24]</measure>
      <time_frame>24 weeks</time_frame>
      <description>Participants will provide photos of their face for virtual skin grading by dermatologist.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Changes in blood serum levels of vitamin A. [Baseline to Week 24]</measure>
      <time_frame>24 weeks</time_frame>
      <description>Participants will undergo blood draws to assess blood serum levels of vitamin A.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Changes in participants perception of facial acne. [Baseline to Week 24]</measure>
      <time_frame>24 weeks</time_frame>
      <description>Survey-based assessment (0-5 scale) of participants perception of changes to their facial acne.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Changes in symptoms of premenstrual syndrome (PMS). [Baseline to Week 24]</measure>
      <time_frame>24 weeks</time_frame>
      <description>Survey-based assessment (0-5 scale) of common symptoms associated with PMS.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">60</enrollment>
    <condition>Acne</condition>
    <condition>Premenstrual Syndrome</condition>
    <arm_group>
      <arm_group_label>Group One: Skincare Routine Only</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Participants will follow instructions for the skincare routine only. Participants will complete the routine twice daily.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Group Two: Skincare Routine + Supplement</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Participants will follow instructions for the skincare routine AND will take a daily supplement.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Skincare Routine</intervention_name>
      <description>Morning:&#xD;
  1. GENTLECLEAN - Wash with a quarter-sized amount of lukewarm water. Pat skin dry after.&#xD;
  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).&#xD;
  Night:&#xD;
  VITAMINSCRUB - Wet your face with lukewarm water &amp; 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.&#xD;
  CLEARITY - Apply 2-3 pumps and massage into the skin avoiding the eye area. Let sit for 10-15 minutes. Do not wash off.&#xD;
  CELLRENEW - Shake well, apply 2-3 pumps over the entire face, and massage into the skin&#xD;
  HYDRAGLOW - Apply a dime-size amount of lotion and massage into the face</description>
      <arm_group_label>Group One: Skincare Routine Only</arm_group_label>
      <arm_group_label>Group Two: Skincare Routine + Supplement</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Dietary Supplement</intervention_type>
      <intervention_name>MINDBODYSKIN Supplement</intervention_name>
      <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.</description>
      <arm_group_label>Group Two: Skincare Routine + Supplement</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          Female 18 years of age or older Have regular acne Have any noticeable PMS symptoms like&#xD;
          stress, bloating, mood swings, acne Be generally healthy (i.e. don't live with any&#xD;
          uncontrolled chronic disease besides acne).&#xD;
  &#xD;
          Have a body weight of &gt;120 lbs.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          Have any pre-existing conditions that would prevent participants from adhering to the&#xD;
          protocol, including oncological and psychiatric disorders.&#xD;
  &#xD;
          Be currently using any prescribed medications for their face Anyone with any known severe&#xD;
          allergic reactions Women who are pregnant, breastfeeding or attempting to become pregnant&#xD;
          Anyone unwilling to follow the study protocol&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Citruslabs</name>
        <address>
          <city>Santa Monica</city>
          <state>California</state>
          <zip>90404</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 24, 2023</study_first_submitted>
    <study_first_submitted_qc>August 24, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 30, 2023</study_first_posted>
    <last_update_submitted>August 24, 2023</last_update_submitted>
    <last_update_submitted_qc>August 24, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 30, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Premenstrual Syndrome</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06018168
  org study id: 20282
  nct id: NCT06018168
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  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.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention 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.
  primary purpose: Other
  masking: None (Open Label)
  measure: Changes in facial acne. [Baseline to Week 24]
  time frame: 24 weeks
  description: Participants will provide photos of their face for virtual skin grading by dermatologist.
  measure: Changes in blood serum levels of vitamin A. [Baseline to Week 24]
  time frame: 24 weeks
  description: Participants will undergo blood draws to assess blood serum levels of vitamin A.
  measure: Changes in participants perception of facial acne. [Baseline to Week 24]
  time frame: 24 weeks
  description: Survey-based assessment (0-5 scale) of participants perception of changes to their facial acne.
  measure: Changes in symptoms of premenstrual syndrome (PMS). [Baseline to Week 24]
  time frame: 24 weeks
  description: Survey-based assessment (0-5 scale) of common symptoms associated with PMS.
  arm group label: Group One: Skincare Routine Only
  arm group type: Active Comparator
  description: Participants will follow instructions for the skincare routine only. Participants will complete the routine twice daily.
  arm group label: Group Two: Skincare Routine + Supplement
  arm group type: Active Comparator
  description: Participants will follow instructions for the skincare routine AND will take a daily supplement.
  intervention type: Other
  intervention name: Skincare Routine
  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
  arm group label: Group One: Skincare Routine Only
  arm group label: Group Two: Skincare Routine + Supplement
  intervention type: Dietary Supplement
  intervention name: MINDBODYSKIN Supplement
  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.
  arm group label: Group Two: Skincare Routine + Supplement
  criteria: 
  gender: Female
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  facility: 
  country: United States
  responsible party type: Sponsor
  mesh term: Premenstrual Syndrome
  sharing ipd: Undecided