AcnePhase 4NCT05446402
Investigation of the Tolerability of Two Facial Cleansing Routines for Mild to Moderate Acne
A Phase 4 study testing Geologie Acne Regimen - one side of face and Proactive Acne Regimen - other side of face in people with Acne, run by Northwestern University at 1 site in United States.
Trial summary
The objective of this study is to compare tolerability of two similar commercially available over the counter acne regimens (Geologie and Proactiv) in individuals with mild to moderate acne vulgaris over a 12-week daily treatment course. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acne
- What is being tested?
- Geologie Acne Regimen - one side of face and Proactive Acne Regimen - other side of face
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jun 2022to 31 Dec 2023
- Phase
- Phase 4
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years or older
- No known active skin infection.
- Presence of mild or moderate acne on face (clinical diagnosis or self-report)
- Willingness to give written consent and comply with study procedures.
Who cannot join
- Active skin infection.
- Inability to understand instructions or procedures involved.
- Known allergy to ingredient(s) in products being used for study.
- Pregnant women, prisoners, and vulnerable populations.
- Has a history of acute or chronic disease that may interfere with or increase the risk of study participation.
- Has any dermatological disorder that may interfere with the accurate evaluation of the subject's facial appearance, based on the opinion of the investigator.
Trial locations and contacts
1 site in 1 country.
United States1 site
Northwestern University Department of Dermatology
Chicago, Illinois, 60611
About this study
Official title: Double Blinded, Split Face Investigation of the Tolerability of Two Facial Cleansing Routines for Mild to Moderate Acne
The objective of this study is to compare tolerability of two similar commercially available over the counter acne regimens (Geologie and Proactiv) in individuals with mild to moderate acne vulgaris over a 12-week daily treatment course.
Read the detailed description
Acne vulgaris is a common, chronic inflammatory skin disorder that originates in the pilosebaceous unit. Acne typically begins in adolescence and often continues into adulthood, with about 20% of cases resulting in scars or hyperpigmentation. It's estimated that acne affects about 85% of adolescents. Individuals who experience acne and acne scars tend to also experience a negative impact on their social and mental health, including depression, anxiety, and social withdrawal. Currently, topical solutions and lifestyle changes are the primary treatment for mild to moderate acne.
This study will evaluate and compare the efficacy of two over the counter products in treating individuals with mild to moderate acne: Geologie and ProActive. Both sets of products will be provided to Northwestern in identical, unlabeled bottles for the purpose of blinding.
- Conditions
- Acne
- Being tested
- Geologie Acne Regimen - one side of face, Proactive Acne Regimen - other side of face
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Geologie Acne Regimen - one side of faceCombination product
Geologie is an over-the-counter cosmetic acne regimen with three products. The regimen also has three "levels" over the course of three months, in which the nighttime lotion is switched to a stronger formula each month. The Geologie Clear System regimen for acne prone skin includes:
- Clarifying Gel Cleanser - SA Formula (2% Salicylic Acid)
- Brightening Day Cream - SPF 15 (5% Azelaic Acid, 2% Hyaluronic Acid, 1%Niacinamide)
- Repairing Night Cream -
- Level 1 (0.05% Retinol, 3% Niacinamide, 2% Hyaluronic Acid)
- Level 2 (0.2% Retinol, 3% Niacinamide, 2% Hyaluronic Acid)
- Level 3 (0.3% Retinol, 3% Niacinamide, 2% Hyaluronic Acid)
Proactive Acne Regimen - other side of faceCombination product
ProActiv is an over-the-counter cosmetic regimen with three products. The
Proactiv Solution 3-Piece System regimen includes:
- Renewing Cleanser (Active ingredient: 2.5% Benzoyl Peroxide)
- Revitalizing Toner (Glycolic Acid)
- Repairing Treatment (Active ingredient: 2.5% Benzoyl Peroxide)
| Study group | Role | What they receive |
|---|---|---|
| Acne Treatment | Experimental | Not described Receives: Combination Product: Geologie Acne Regimen - one side of face; Combination Product: Proactive Acne Regimen - other side of face |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in IGA Score between Geologie and ProActiv daily treatment
Investigator Global Assessment (IGA) will be collected on a scale of 0-4 with 0 being clear and 4 being severe.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2022
- Study start15 Jun 2022
- Primary completion31 May 2023
- Study completion31 Dec 2023
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.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Participants will be using Product 1 regimen on left side of face for 12 weeks and Product 2 regimen on right side of face for 12 weeks.
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stephanie Rangel, Northwestern University
- Investigators
- Stephanie Rangel, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05446402
- Sponsor's protocol ID
- STU#00217056
- Status last verified
- Apr 2024
- First submitted
- 30 Jun 2022
- Last updated
- 11 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double Blinded, Split Face Investigation of the Tolerability of Two Facial Cleansing Routines for Mild to Moderate Acne
- ClinicalTrials.gov ID
- NCT05446402
- Acronym / sponsor ID
- STU#00217056
- Conditions
- Acne
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- 15 Jun 2022 (actual)
- Primary completion
- 31 May 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 6 Jul 2022 (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.
The objective of this study is to compare tolerability of two similar commercially available over the counter acne regimens (Geologie and Proactiv) in individuals with mild to moderate acne vulgaris over a 12-week daily treatment course.
Detailed description
Acne vulgaris is a common, chronic inflammatory skin disorder that originates in the pilosebaceous unit. Acne typically begins in adolescence and often continues into adulthood, with about 20% of cases resulting in scars or hyperpigmentation. It's estimated that acne affects about 85% of adolescents. Individuals who experience acne and acne scars tend to also experience a negative impact on their social and mental health, including depression, anxiety, and social withdrawal. Currently, topical solutions and lifestyle changes are the primary treatment for mild to moderate acne.
This study will evaluate and compare the efficacy of two over the counter products in treating individuals with mild to moderate acne: Geologie and ProActive. Both sets of products will be provided to Northwestern in identical, unlabeled bottles for the purpose of blinding.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Participants will be using Product 1 regimen on left side of face for 12 weeks and Product 2 regimen on right side of face for 12 weeks.
| Arm | Type | Receives |
|---|---|---|
| Acne Treatment | Experimental | Combination Product: Geologie Acne Regimen - one side of face, Combination Product: Proactive Acne Regimen - other side of face |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 years or older
- No known active skin infection.
- Presence of mild or moderate acne on face (clinical diagnosis or self-report)
- Willingness to give written consent and comply with study procedures.
Key exclusion criteria (6 listed)
- Active skin infection.
- Inability to understand instructions or procedures involved.
- Known allergy to ingredient(s) in products being used for study.
- Pregnant women, prisoners, and vulnerable populations.
- Has a history of acute or chronic disease that may interfere with or increase the risk of study participation.
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 |
|---|---|---|
| Geologie Acne Regimen - one side of faceGeologie is an over-the-counter cosmetic acne regimen with three products. The regimen also has three "levels" over the course of three months, in which the nighttime lotion is switched to a stronger formula each month. The Geologie Clear System regimen for acne prone skin includes: 1. Clarifying Gel Cleanser - SA Formula (2% Salicylic Acid) 2. Brightening Day Cream - SPF 15 (5% Azelaic Acid, 2% Hyaluronic Acid, 1%Niacinamide) 3. Repairing Night Cream - 1. Level 1 (0.05% Retinol, 3% Niacinamide, 2% Hyaluronic Acid) 2. Level 2 (0.2% Retinol, 3% Niacinamide, 2% Hyaluronic Acid) 3. Level 3 (0.3% Retinol, 3% Niacinamide, 2% Hyaluronic Acid) | Combination product | Acne Treatment |
| Proactive Acne Regimen - other side of faceProActiv is an over-the-counter cosmetic regimen with three products. The Proactiv Solution 3-Piece System regimen includes: 1. Renewing Cleanser (Active ingredient: 2.5% Benzoyl Peroxide) 2. Revitalizing Toner (Glycolic Acid) 3. Repairing Treatment (Active ingredient: 2.5% Benzoyl Peroxide) | Combination product | Acne Treatment |
Primary outcome
Change in IGA Score between Geologie and ProActiv daily treatment
Time frame: 12 weeks
Investigator Global Assessment (IGA) will be collected on a scale of 0-4 with 0 being clear and 4 being severe.
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 11 Apr 2024.
- Individual participant dataSharing planned: No
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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.
Stephanie Rangel principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Geologie Acne Regimen - one side of face and Proactive Acne Regimen - other side of face in people with Acne, run by Northwestern University 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 4 inclusion and 6 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 11 Apr 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Change in IGA Score between Geologie and ProActiv daily treatment (time frame: 12 weeks). 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 11 Apr 2024.