Acne VulgarisNCT05069272
Double-blinded, Vehicle Controlled Study to Evaluate Efficacy & Tolerance of Bakuchiol and Ethyl Linoleate on Acne
A study testing Bakuchiol and Ethyl Linoleate in people with Acne Vulgaris, run by Ratan K. Chaudhuri at 1 site in United Kingdom.
Trial summary
Subjects will be assigned to a active cream or vehicle to compare the cosmetic effects. This will take place over a 12 week period. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Acne Vulgaris
- What is being tested?
- Bakuchiol and Ethyl Linoleate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 10 Sep 2021to 30 Jan 2025
- 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 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy female volunteers, aged 18 years or older;
- with mild to moderate acne;
- Subjects must have between 10-100 non-inflammatory lesions and 10-50 inflammatory lesions but no more than 2 nodular lesions and no cysts on their face.
- If applicable, users of estrogens/birth control pills must have been on the treatment regimen for at least 3 months and be willing to continue use for study duration;
- Females of child-bearing potential (FCBP): A female is considered not to be of childbearing potential if she is post-menopausal with at least 12 consecutive months of amenorrhea or has undergone surgical sterilization. While on the study, FCBP who engage in activity in which conception is possible must use one of the approved contraceptive options described below:
- Option 1: Any one of the following highly effective methods: hormonal contraception (oral, injection, implant, transdermal patch, vaginal ring); intrauterine device (IUD); tubal ligation; or partner's vasectomy; OR
Show all 9Show fewer
- Option 2: Male or female condom (latex condom or nonlatex condom NOT made out of natural [animal] membrane [for example, polyurethane]; PLUS one additional barrier method: (a) diaphragm with spermicide; (b) cervical cap with spermicide; or (c) contraceptive sponge with spermicide.
- Willing to follow study instructions and available to attend the study visits;
- Willing to provide written informed consent and sign photography release
Who cannot join
- Female subjects: Self-reported pregnant or breast feeding, or planning to become pregnant during the course of the study;
- Known allergy or hypersensitivity to acne treatment products;
- Current skin disease of any type in the test area (e.g. eczema, psoriasis, rosacea, seborrheic dermatitis, vitiligo, etc.), or under the treatment of a doctor for any skin condition;
- Have any cystic acne, acne conglobate, acne fulminans, or secondary acne (chloracne or drug-induced acne) in the test area;
- Any conditions on the test site that would interfere with evaluations (i.e. tattoos, scars, open cuts, sunburn, piercings, excessive hair, etc.);
- Use of topical treatments such as OTC (over the counter) acne medication topical anti-inflammatory medications, salicylic acid, corticosteroids, antibiotics, anti-bacterials, peroxide-containing products, or retinoids within 2 weeks of baseline;
Show all 14Show fewer
- Use of depigmenting medications such as hydroquinone during the 14 days prior to the study start; Insulin dependent diabetes;
- Concurrent medication that might affect the response to the test articles including routine use of anti-inflammatory medications, anti-histamines, and steroids;
- History of Crohn's disease, or clinically significant enteritis (regional enteritis, ulcerative colitis, pseudomembranous colitis, antibiotic-associated colitis);
- Microdermabrasion or laser treatment in the test area within six months of the study;
- Medical condition which, in the opinion of the Investigator, would compromise the safety of the subject or confound study results;
- Use of systemic antibiotics, corticosteroids, antimalarials or oral dapsone within 4 weeks of baseline;
- Use of other anti-acne medications, including isotretinoin or spironolactone, within 6 months of baseline;
- Participation on an investigational drug study within 4 months of the baseline visit.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Princeton Consumer Research Corp
Chelmsford, England, CM2 6UA
Terrie Bennett Bennett, 44(0)1245 934050
Barrie Drewitt Drewitt
About this study
Official title: A Randomized, Double-blinded, Vehicle Controlled, Monocentric Study to Evaluate the Efficacy and Tolerance of Synergistic Combination of Bakuchiol and Ethyl Linoleate on Mild to Moderate Acne Vulgaris
Subjects will be assigned to a active cream or vehicle to compare the cosmetic effects. This will take place over a 12 week period.
- Conditions
- Acne Vulgaris
- Being tested
- Bakuchiol and Ethyl Linoleate, Vehicle
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bakuchiol and Ethyl LinoleateOther
A synergistic combination of Bakuchiol and Ethyl Linoleate
VehicleOther
No actives
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Active comparator | Synergistic combination of Bakuchiol and Ethyl Linoleate Receives: Other: Bakuchiol and Ethyl Linoleate |
| Vehicle | Placebo comparator | No active ingredients Receives: Other: Vehicle |
What is being measured
The primary outcome is the main question the study is designed to answer.
IGA Score
IGA score of zero (clear) or one (almost clear)
Measured: From baseline to week 12
Facial lesions
Percent reductions in facial lesion counts for inflammatory and noninflammatory
Measured: From baseline to week 12
Secondary outcomes (19)
Total lesion count
Percent change in Global Face Total Lesion Count
Measured: From baseline to week 2
Total lesion count
Percent change in Global Face Total Lesion Count
Measured: From baseline to week 4
Total lesion count
Percent change in Global Face Total Lesion Count
Measured: From baseline to week 8
Total lesion count
Percent change in Global Face Total Lesion Count
Measured: From baseline to week 12
IGA score
IGA score of zero (clear) or one (almost clear) as compared to vehicle
Measured: From baseline to week 2, 4, 8, 12
IGA score
IGA score of zero (clear) or one (almost clear)
Measured: From baseline to week 4
IGA score
IGA score of zero (clear) or one (almost clear)
Measured: From baseline to week 8
IGA score
IGA score of zero (clear) or one (almost clear)
Measured: From baseline to week 12
IGA score
IGA score of zero (clear) or one (almost clear) as compared to vehicle
Measured: From baseline to week 2, 4, 8 & 12
Inflammatory and non-inflammatory leisons
Percent reductions in facial lesion counts for inflammatory and noninflammatory
Measured: From baseline to week 2
Inflammatory and non-inflammatory leisons
Percent reductions in facial lesion counts for inflammatory and noninflammatory
Measured: From baseline to week 4
Inflammatory and non-inflammatory leisons
Percent reductions in facial lesion counts for inflammatory and noninflammatory
Measured: From baseline to week 8
Inflammatory and non-inflammatory leisons
Percent reductions in facial lesion counts for inflammatory and noninflammatory
Measured: From baseline to week 12
Inflammatory and non-inflammatory leisons
Percent reductions in facial lesion counts for inflammatory and noninflammatory as compared to vehicle
Measured: From baseline to week 2, 4, 8 & 12
Post inflammatory hyperpigmentation
Percent reduction in overall post inflammatory hyperpigmentation
Measured: From baseline to week 2
Post inflammatory hyperpigmentation
Percent reduction in overall post inflammatory hyperpigmentation
Measured: From baseline to week 4
Post inflammatory hyperpigmentation
Percent reduction in overall post inflammatory hyperpigmentation
Measured: From baseline to week 8
Post inflammatory hyperpigmentation
Percent reduction in overall post inflammatory hyperpigmentation
Measured: From baseline to week 12
Post inflammatory hyperpigmentation
Percent reduction in overall post inflammatory hyperpigmentation as compared to vehicle
Measured: From baseline to week 2, 4, 8 & 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2021
- Study start10 Sep 2021
- Primary completion20 Feb 2022 (estimated)
- Study completion30 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acne VulgarisStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ratan K. Chaudhuri
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor-investigator, Ratan K. Chaudhuri, Sytheon Ltd.
- Investigators
- Barrie Drewitt, Principal investigator, Princeton Consumer Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05069272
- Sponsor's protocol ID
- SYTPIG1M
- Status last verified
- Oct 2021
- First submitted
- 23 Sep 2021
- Last updated
- 6 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan on sharing IPD to other researchers
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blinded, Vehicle Controlled, Monocentric Study to Evaluate the Efficacy and Tolerance of Synergistic Combination of Bakuchiol and Ethyl Linoleate on Mild to Moderate Acne Vulgaris
- ClinicalTrials.gov ID
- NCT05069272
- Acronym / sponsor ID
- SYTPIG1M
- Conditions
- Acne Vulgaris
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Ratan K. ChaudhuriIndustry (pharma, biotech, devices)
- Study start
- 10 Sep 2021 (actual)
- Primary completion
- 20 Feb 2022 (estimated)
- Study completion
- 30 Jan 2025 (estimated)
- First posted
- 6 Oct 2021 (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.
Subjects will be assigned to a active cream or vehicle to compare the cosmetic effects. This will take place over a 12 week period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Active comparator | Other: Bakuchiol and Ethyl LinoleateSynergistic combination of Bakuchiol and Ethyl Linoleate |
| Vehicle | Placebo comparator | Other: VehicleNo active ingredients |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Healthy female volunteers, aged 18 years or older;
- with mild to moderate acne;
- Subjects must have between 10-100 non-inflammatory lesions and 10-50 inflammatory lesions but no more than 2 nodular lesions and no cysts on their face.
- If applicable, users of estrogens/birth control pills must have been on the treatment regimen for at least 3 months and be willing to continue use for study duration;
- Females of child-bearing potential (FCBP): A female is considered not to be of childbearing potential if she is post-menopausal with at least 12 consecutive months of amenorrhea or has undergone surgical sterilization. While on the study, FCBP who engage in activity in which conception is possible must use one of the approved contraceptive options described below:
Key exclusion criteria (14 listed)
- Female subjects: Self-reported pregnant or breast feeding, or planning to become pregnant during the course of the study;
- Known allergy or hypersensitivity to acne treatment products;
- Current skin disease of any type in the test area (e.g. eczema, psoriasis, rosacea, seborrheic dermatitis, vitiligo, etc.), or under the treatment of a doctor for any skin condition;
- Have any cystic acne, acne conglobate, acne fulminans, or secondary acne (chloracne or drug-induced acne) in the test area;
- Any conditions on the test site that would interfere with evaluations (i.e. tattoos, scars, open cuts, sunburn, piercings, excessive hair, etc.);
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 |
|---|---|---|
| Bakuchiol and Ethyl LinoleateA synergistic combination of Bakuchiol and Ethyl Linoleate | Other | Intervention |
| VehicleNo actives | Other | Vehicle |
Primary outcome
IGA Score
Time frame: From baseline to week 12
IGA score of zero (clear) or one (almost clear)
Facial lesions
Time frame: From baseline to week 12
Percent reductions in facial lesion counts for inflammatory and noninflammatory
19 secondary outcomes
Total lesion count
Time frame: From baseline to week 2
Total lesion count
Time frame: From baseline to week 4
Total lesion count
Time frame: From baseline to week 8
Total lesion count
Time frame: From baseline to week 12
IGA score
Time frame: From baseline to week 2, 4, 8, 12
IGA score
Time frame: From baseline to week 4
IGA score
Time frame: From baseline to week 8
IGA score
Time frame: From baseline to week 12
IGA score
Time frame: From baseline to week 2, 4, 8 & 12
Inflammatory and non-inflammatory leisons
Time frame: From baseline to week 2
Inflammatory and non-inflammatory leisons
Time frame: From baseline to week 4
Inflammatory and non-inflammatory leisons
Time frame: From baseline to week 8
Inflammatory and non-inflammatory leisons
Time frame: From baseline to week 12
Inflammatory and non-inflammatory leisons
Time frame: From baseline to week 2, 4, 8 & 12
Post inflammatory hyperpigmentation
Time frame: From baseline to week 2
Post inflammatory hyperpigmentation
Time frame: From baseline to week 4
Post inflammatory hyperpigmentation
Time frame: From baseline to week 8
Post inflammatory hyperpigmentation
Time frame: From baseline to week 12
Post inflammatory hyperpigmentation
Time frame: From baseline to week 2, 4, 8 & 12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2021.
- Individual participant dataSharing planned: No. No plan on sharing IPD to other researchers
Related trials for Acne Vulgaris
RecruitingPhase 3
Study of New Antiandrogenic Progestogen + Low-dose Estrogen for Moderate Acne Vulgaris
Acne Vulgaris, Acne Vulgaris on the Face
Not yet recruiting
A Single-Center, Open-Label Study to Assess the Efficacy and Tolerability of a Brightening Serum in Skin of Color Patients With Post Inflammatory Hyperpigmentation
Post-inflammatory Hyperpigmentation, Post-acne Hyperpigmentation
RecruitingPhase 3
Phase 3 Study of Denifanstat in Participants With Moderate to Severe Acne (AURORA)
Acne Vulgaris
Recruiting
Comparison of Topical Clascoterone 1% Cream Versus Adapalene 0.1% Cream in the Treatment of Mild-to-Moderate Acne Vulgaris
Acne Vulgaris
RecruitingPhase 1
Phase 1 Study to Evaluate the Safety, Tolerability, PK, and PD of TVB-3567 in Healthy Participants With or Without Acne
Acne
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.
Barrie Drewitt principal investigator
Princeton Consumer Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bakuchiol and Ethyl Linoleate in people with Acne Vulgaris, run by Ratan K. Chaudhuri at 1 site in United Kingdom.
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 9 inclusion and 14 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: status not confirmed, as of the sponsor's last update on 6 Oct 2021. 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 Kingdom. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jack Donnelly (44(0)1617911797, jack@princetonconsumer.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
IGA Score (time frame: From baseline to week 12). 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 6 Oct 2021.