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

NCT06120452 | Completed

• 1 other identifier: 20355
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Acne

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Changes in facial skin hydration. [Timeframe: Baseline to Day 56]

  56 days

• Changes in facial skin softness. [Timeframe: Baseline to Day 56]

  56 days

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

  56 days

Study Arms (1)

Test arm: Acne Serum

EXPERIMENTAL

Participants will use the serum after cleansing and toning every morning for 8 weeks (56 days).

Other: Rael Miracle Clear Complete Acne Serum

Interventions

Rael Miracle Clear Complete Acne Serum OTHER

This acne serum contains the following ingredients: 1.5% Salicylic acid. 2% Niacinamide. 0.5% Zinc Pyrrolidone Carboxylic Acid (PCA). Hyaluronic Acid.

Test arm: Acne Serum

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rael: lead
• Citruslabs: collaborator

Study Sites (1)

Citruslabs

Santa Monica, California, 90404, United States

Location

MeSH Terms

Conditions

Acne Vulgaris

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 2023
• First Posted: November 7, 2023
• Study Start: October 6, 2023
• Primary Completion: January 31, 2024
• Study Completion: January 31, 2024
• Last Updated: August 23, 2024

Record last verified: 2024-08

Locations

US (1)