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

Sponsor
Menning Labs (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT06122467
Collaborator
Citruslabs (Industry)
36
1
1
3
12.2

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Other: EQ Exfoliating Cleanser
  • Other: EQ Gel
  • Other: EQ Moisturizer
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
36 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
A Single Group Study to Evaluate the Efficacy of a Cosmetic Product Line on Acne Symptoms
Actual Study Start Date :
Oct 2, 2023
Anticipated Primary Completion Date :
Dec 31, 2023
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

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.

Other: EQ Exfoliating Cleanser
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).

Other: EQ Gel
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.

Other: EQ Moisturizer
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.

Outcome Measures

Primary Outcome Measures

  1. Change in the appearance of facial skin acne. [Timeframe: Baseline to Day 56] [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.

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

Secondary Outcome Measures

  1. Changes in overall skin health. [Timeframe: Baseline to Day 56] [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.

  2. Changes in skin texture. [Timeframe: Baseline to Day 56] [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.

  3. Changes in facial skin irritation. [Timeframe: Baseline to Day 56] [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").

  4. Changes in skin redness. [Timeframe: Baseline to Day 56] [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.

  5. Changes in skin smoothness. [Timeframe: Baseline to Day 56] [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").

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 45 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Citruslabs Santa Monica California United States 90404

Sponsors and Collaborators

  • Menning Labs
  • Citruslabs

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Menning Labs
ClinicalTrials.gov Identifier:
NCT06122467
Other Study ID Numbers:
  • 20365
First Posted:
Nov 8, 2023
Last Update Posted:
Nov 8, 2023
Last Verified:
Nov 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 8, 2023