A Clinical Trial to Evaluate the Effectiveness of an Acne Serum in Improving Facial Acne and Post-Acne Pigmentation

This study will evaluate the efficacy of the Rael Miracle Clear Complete Acne Serum product in improving facial acne and post-acne pigmentation. This study will last for 56 days. The study will be conducted as a single-arm trial where all participants will use the test products. Participants will be required to complete questionnaires at Baseline, Day 1, Day 3, Day 7, Day 14, Day 28, and Day 56. Photos will be taken at Baseline, Day 28, and Day 56. The photos from Baseline and Day 56 will undergo expert skin grading

Study Overview

• Status: Completed
• Conditions: Acne
• Intervention / Treatment: Other: Rael Miracle Clear Complete Acne Serum

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Female. Age 18+. Currently experiencing mild to moderate acne issues. Generally healthy -and not living with any uncontrolled chronic disease.

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 an oral and/or topical prescription acne treatment. Anyone unwilling to stop using their current acne supplements. Anyone with known severe allergic reactions. Anyone unwilling to avoid excessive sun exposure. Anyone who is breastfeeding, pregnant, or attempting to become pregnant. Anyone unwilling to follow the study protocol. Anyone who identifies as having sensitive skin.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Test arm: Acne Serum; Participants will use the serum after cleansing and toning every morning for 8 weeks (56 days).	Other: Rael Miracle Clear Complete Acne Serum; This acne serum contains the following ingredients: 1.5% Salicylic acid. 2% Niacinamide. 0.5% Zinc Pyrrolidone Carboxylic Acid (PCA). Hyaluronic Acid.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in the appearance of facial acne. [Timeframe: Baseline to Day 56]	Before and after photos will undergo virtual skin grading by a board-certified dermatologist to assess this change. Participants will also complete questionnaires rating the appearance of their facial acne. Questionnaires will use a 5-point Likert scale, with 0 indicating the less favourable response and 5 indicating the most favourable response.	56 days
Changes in the appearance of post-acne pigmentation. [Timeframe: Baseline to Day 56]	Before and after photos will undergo virtual skin grading by a board-certified dermatologist to assess this change. Participants will also complete questionnaires rating the appearance of their post-acne pigmentation. Questionnaires will use a 5-point Likert scale, with 0 indicating the less favourable response and 5 indicating the most favourable response.	56 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in facial skin hydration. [Timeframe: Baseline to Day 56]	Before and after photos will undergo virtual skin grading by a board-certified dermatologist to assess this change. Participants will also complete questionnaires rating their perception of facial skin hydration. Questionnaires will use a 5-point Likert scale, with 0 indicating the less favourable response and 5 indicating the most favourable response.	56 days
Changes in facial skin softness. [Timeframe: Baseline to Day 56]	Participants will complete questionnaires rating their perception of facial skin softness. Questionnaires will use a 5-point Likert scale, with 0 indicating the less favourable response and 5 indicating the most favourable response.	56 days
Changes in facial skin texture. [Timeframe: Baseline to Day 56]	Before and after photos will undergo virtual skin grading by a board-certified dermatologist to assess this change. Participants will also complete questionnaires rating their perception of facial skin texture. Questionnaires will use a 5-point Likert scale, with 0 indicating the less favourable response and 5 indicating the most favourable response.	56 days

Collaborators and Investigators

• Sponsor: Rael
• Collaborators: Citruslabs

Study record dates

Study Major Dates

• Study Start (Actual): October 6, 2023
• Primary Completion (Actual): January 31, 2024
• Study Completion (Actual): January 31, 2024

Study Registration Dates

• First Submitted: November 2, 2023
• First Submitted That Met QC Criteria: November 2, 2023
• First Posted (Actual): November 7, 2023

Study Record Updates

• Last Update Posted (Actual): August 23, 2024
• Last Update Submitted That Met QC Criteria: August 21, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Acneiform Eruptions; Sebaceous Gland Diseases; Acne Vulgaris
• Other Study ID Numbers: 20355

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No