A Single Group Study to Evaluate the Efficacy of a Cosmetic Product Line on Acne Symptoms

March 18, 2024 updated by: Menning Labs
This twelve-week trial will examine the effectiveness of a Menning Labs EQ Product Line acne product. Participants will use the exfoliating cleanser, cream, and gel daily for 8 weeks. Participants will complete questionnaires at Baseline, Day 1, Day 3, Day 7, Day 28, Day 42, and Day 56. Participants will also provide before-and-after photos at Baseline, Day 7, and Day 42, as well as undergo expert skin grading at Baseline and Day 42. The questionnaire on Day 56 will mark the conclusion of the trial.

Study Overview

Status

Completed

Conditions

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • California
      • Santa Monica, California, United States, 90404
        • Citruslabs

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Be aged between 18-45.
  • Anyone who has acne prone skin and a history of recurring acne.
  • Has visible acne at enrollment.
  • Anyone who is generally healthy - does not live with any uncontrolled chronic disease.
  • Have a digital camera or smartphone to take photos of the face.

Exclusion Criteria:

  • Anyone with pre-existing chronic conditions that would prevent participants from adhering to the protocol, including oncological and psychiatric disorders.
  • Anyone currently using a prescription skin product.
  • Anyone who is unwilling to stop using the current acne supplements they are taking.
  • Anyone with known severe allergic reactions.
  • Any women who are pregnant, breastfeeding or attempting to become pregnant.
  • Anyone unwilling to follow the study protocol.
  • Anyone who identifies as having sensitive skin.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Test group: EQ Product Line

The following regimen should be completed in both the morning and the evening. The order of use is:

Cleanser Gel Moisturizer.

Product contains: Purified water, disodium laureth sulfosuccinate, coco betaine, decyl glucoside, Juglans regia (walnut) shells, PEG-40 hydrogenated castor oil, sodium cocoyl isethionate disodium cocoyl glutamate, ethoxydiglycol, xanthan gum, Root Blend Preservative (hexylene glycol, caprylyl glycol, Wasabia japonica (wasabi) root extract, Zingiber officinale (ginger) root extract, Allium sativum (garlic) bulb extract), Aloe barbadensis (aloe vera) leaf juice concentrate (Aloe barbadensis leaf juice, potassium sorbate, sodium benzoate, citric acid).
Product contains: Purified water, witch hazel (containing 14% grain alcohol), PEG-40 hydrogenated castor oil, ethoxydiglycol, xanthan gum, Root Blend Preservative (hexylene glycol, caprylyl glycol, Wasabia japonica (wasabi) root extract, Zingiber officinale (ginger) root extract, Allium sativum (garlic) bulb extract), xanthan gum.
Product contains: Purified water, glycerin, dicaprylyl carbonate, cetyl alcohol, glyceryl stearate citrate, squalane, PEG-40 hydrogenated castor oil, caprylic/capric triglycerides, stearic acid, jojoba oil, phenoxyethanol SA (phenoxyethanol, caprylyl glycol, sorbic acid), ethoxydiglycol, Root Blend Preservative (hexylene glycol, caprylyl glycol, Wasabia japonica (wasabi) root extract, Zingiber officinale (ginger) root extract, Allium sativum (garlic) bulb extract), allantoin, sodium carbomer.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in the appearance of facial skin acne. [Timeframe: Baseline to Day 56]
Time Frame: 56 days

Assessed via expert skin grading of baseline and endline photos conducted by a board-certified dermatologist.

Study-specific surveys using a 5-point Likert scale with 5 representing the most favorable/best outcome (e.g., "Not at all") and 1 representing the least favorable/worst outcome (e.g., "Severe"). Surveys will be completed independently by study participants.

56 days
Changes in skin clarity i.e. reduction in acne or associated blemishes. [Timeframe: Baseline to Day 56]
Time Frame: 56 days

Assessed via expert skin grading of baseline and endline photos conducted by a board-certified dermatologist.

Study-specific surveys using a 5-point Likert scale with 5 representing the most favorable/best outcome (e.g., "Not at all") and 1 representing the least favorable/worst outcome (e.g., "Severe"). Surveys will be completed independently by study participants.

56 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in overall skin health. [Timeframe: Baseline to Day 56]
Time Frame: 56 days

Assessed via expert skin grading of baseline and endline photos conducted by a board-certified dermatologist.

Study-specific surveys using a 5-point Likert scale with 5 representing the most favorable/best outcome (e.g., "Not at all") and 1 representing the least favorable/worst outcome (e.g., "Severe"). Surveys will be completed independently by study participants.

56 days
Changes in skin texture. [Timeframe: Baseline to Day 56]
Time Frame: 56 days

Assessed via expert skin grading of baseline and endline photos conducted by a board-certified dermatologist.

Study-specific surveys using a 5-point Likert scale with 5 representing the most favorable/best outcome (e.g., "Not at all") and 1 representing the least favorable/worst outcome (e.g., "Severe"). Surveys will be completed independently by study participants.

56 days
Changes in facial skin irritation. [Timeframe: Baseline to Day 56]
Time Frame: 56 days
Surveys will be completed independently by study participants. Study-specific surveys using a 5-point Likert scale with 5 representing the most favorable/best outcome (e.g., "Not at all") and 1 representing the least favorable/worst outcome (e.g., "Severe").
56 days
Changes in skin redness. [Timeframe: Baseline to Day 56]
Time Frame: 56 days

Assessed via expert skin grading of baseline and endline photos conducted by a board-certified dermatologist.

Study-specific surveys using a 5-point Likert scale with 5 representing the most favorable/best outcome (e.g., "Not at all") and 1 representing the least favorable/worst outcome (e.g., "Severe"). Surveys will be completed independently by study participants.

56 days
Changes in skin smoothness. [Timeframe: Baseline to Day 56]
Time Frame: 56 days
Assessed by surveys completed independently by study participants. Study-specific surveys using a 5-point Likert scale with 5 representing the most favorable/best outcome (e.g., "Not at all") and 1 representing the least favorable/worst outcome (e.g., "Severe").
56 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Collaborators

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 2, 2023

Primary Completion (Actual)

December 31, 2023

Study Completion (Actual)

December 31, 2023

Study Registration Dates

First Submitted

November 2, 2023

First Submitted That Met QC Criteria

November 2, 2023

First Posted (Actual)

November 8, 2023

Study Record Updates

Last Update Posted (Actual)

March 20, 2024

Last Update Submitted That Met QC Criteria

March 18, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • 20365

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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