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

Acne Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06120452
• Other study ID #: 20355
• Status: Recruiting
• Phase: N/A
• Start date: October 6, 2023
• Est. completion date: January 31, 2024

Study information

• Verified date: November 2023
• Source: Rael
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: January 31, 2024
• Est. primary completion date: January 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acne
• Acne Vulgaris

Intervention

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.

Locations

Country	Name	City	State
United States	Citruslabs	Santa Monica	California

Sponsors (2)

Lead Sponsor	Collaborator
Rael	Citruslabs

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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