AcneNCT06120452
A Clinical Trial to Evaluate the Effectiveness of an Acne Serum in Improving Facial Acne and Post-Acne Pigmentation
A study testing Rael Miracle Clear Complete Acne Serum in people with Acne, run by Rael at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Acne
- What is being tested?
- Rael Miracle Clear Complete Acne Serum
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Oct 2023to 31 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Female. Age 18+. Currently experiencing mild to moderate acne issues. Generally healthy -and not living with any uncontrolled chronic disease.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Rael Miracle Clear Complete Acne Serum
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rael Miracle Clear Complete Acne SerumOther
This acne serum contains the following ingredients:
1.5% Salicylic acid. 2% Niacinamide. 0.5% Zinc Pyrrolidone Carboxylic Acid (PCA). Hyaluronic Acid.
| Study group | Role | What they receive |
|---|---|---|
| Test arm: Acne Serum | Experimental | Participants will use the serum after cleansing and toning every morning for 8 weeks (56 days). Receives: Other: Rael Miracle Clear Complete Acne Serum |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 56 days
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: 56 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2023
- Study start6 Oct 2023
- Primary completion31 Jan 2024
- Study completion31 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AcneStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rael
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Citruslabs
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06120452
- Sponsor's protocol ID
- 20355
- Status last verified
- Aug 2024
- First submitted
- 2 Nov 2023
- Last updated
- 23 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Trial to Evaluate the Effectiveness of an Acne Serum in Improving Facial Acne and Post-Acne Pigmentation
- ClinicalTrials.gov ID
- NCT06120452
- Acronym / sponsor ID
- 20355
- Conditions
- Acne
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- RaelIndustry (pharma, biotech, devices)
- Collaborators
- Citruslabs
- Study start
- 6 Oct 2023 (actual)
- Primary completion
- 31 Jan 2024 (actual)
- Study completion
- 31 Jan 2024 (actual)
- First posted
- 7 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Test arm: Acne Serum | Experimental | Other: Rael Miracle Clear Complete Acne SerumParticipants will use the serum after cleansing and toning every morning for 8 weeks (56 days). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Female. Age 18+. Currently experiencing mild to moderate acne issues. Generally healthy -and not living with any uncontrolled chronic disease.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rael Miracle Clear Complete Acne SerumThis acne serum contains the following ingredients: 1.5% Salicylic acid. 2% Niacinamide. 0.5% Zinc Pyrrolidone Carboxylic Acid (PCA). Hyaluronic Acid. | Other | Test arm: Acne Serum |
Primary outcome
Changes in the appearance of facial acne. [Timeframe: Baseline to Day 56]
Time frame: 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]
Time frame: 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.
3 secondary outcomes
Changes in facial skin hydration. [Timeframe: Baseline to Day 56]
Time frame: 56 days
Changes in facial skin softness. [Timeframe: Baseline to Day 56]
Time frame: 56 days
Changes in facial skin texture. [Timeframe: Baseline to Day 56]
Time frame: 56 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rael Miracle Clear Complete Acne Serum in people with Acne, run by Rael at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in the appearance of facial acne. [Timeframe: Baseline to Day 56] (time frame: 56 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2024.