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

Acne Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06122467
• Other study ID #: 20365
• Status: Completed
• Phase: N/A
• Start date: October 2, 2023
• Est. completion date: December 31, 2023

Study information

• Verified date: March 2024
• Source: Menning Labs
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acne
• Acne Vulgaris

Intervention

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).
• 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.
• 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.

Locations

Country	Name	City	State
United States	Citruslabs	Santa Monica	California

Sponsors (2)

Lead Sponsor	Collaborator
Menning Labs	Citruslabs

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in the appearance of facial skin acne. [Timeframe: Baseline to Day 56]	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
Primary	Changes in skin clarity i.e. reduction in acne or associated blemishes. [Timeframe: Baseline to Day 56]	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	Changes in overall skin health. [Timeframe: Baseline to Day 56]	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	Changes in skin texture. [Timeframe: Baseline to Day 56]	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	Changes in facial skin irritation. [Timeframe: Baseline to Day 56]	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
Secondary	Changes in skin redness. [Timeframe: Baseline to Day 56]	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	Changes in skin smoothness. [Timeframe: Baseline to Day 56]	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