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

Sponsor

Rael (Industry)

Overall Status

Recruiting

CT.gov ID

NCT06120452

Collaborator

Citruslabs (Industry)

Enrollment

Location

Arm

3.8

Anticipated Duration (Months)

10.4

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Acne	Other: Rael Miracle Clear Complete Acne Serum	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Oct 6, 2023

Anticipated Primary Completion Date :

Jan 31, 2024

Anticipated Study Completion Date :

Jan 31, 2024

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Changes in the appearance of facial acne. [Timeframe: Baseline to Day 56] [56 days]
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.
Changes in the appearance of post-acne pigmentation. [Timeframe: Baseline to Day 56] [56 days]
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.

Secondary Outcome Measures

Changes in facial skin hydration. [Timeframe: Baseline to Day 56] [56 days]
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.
Changes in facial skin softness. [Timeframe: Baseline to Day 56] [56 days]
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.
Changes in facial skin texture. [Timeframe: Baseline to Day 56] [56 days]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

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

Sponsors and Collaborators

Rael
Citruslabs

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Rael

ClinicalTrials.gov Identifier:

NCT06120452

Other Study ID Numbers:

20355

First Posted:

Nov 7, 2023

Last Update Posted:

Nov 7, 2023

Last Verified:

Nov 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Acne Vulgaris

Study Results

No Results Posted as of Nov 7, 2023