Double-blinded, Vehicle Controlled Study to Evaluate Efficacy & Tolerance of Bakuchiol and Ethyl Linoleate on Acne

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.

Study Overview

• Status: Recruiting
• Conditions: Acne Vulgaris
• Intervention / Treatment: Other: Bakuchiol and Ethyl Linoleate; Other: Vehicle

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jack Donnelly; Phone Number: 44(0)1617911797; Email: jack@princetonconsumer.com
• Study Contact Backup: Name: Terrie Bennett; Phone Number: 44(0)1245 934050; Email: Terrie@princetonconsumer.com

Study Locations

• United Kingdom
  • England
    • Chelmsford, England, United Kingdom, CM2 6UA
      • Recruiting
      • Princeton Consumer Research Corp
      • Contact: Terrie Bennett Bennett; Phone Number: 44(0)1245 934050
      • Principal Investigator: Barrie Drewitt Drewitt

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• 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
• 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

Exclusion Criteria:

• 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;
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Intervention; Synergistic combination of Bakuchiol and Ethyl Linoleate	Other: Bakuchiol and Ethyl Linoleate; A synergistic combination of Bakuchiol and Ethyl Linoleate
Placebo Comparator: Vehicle; No active ingredients	Other: Vehicle; No actives

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
IGA Score	IGA score of zero (clear) or one (almost clear)	From baseline to week 12
Facial lesions	Percent reductions in facial lesion counts for inflammatory and noninflammatory	From baseline to week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total lesion count	Percent change in Global Face Total Lesion Count	From baseline to week 2
Total lesion count	Percent change in Global Face Total Lesion Count	From baseline to week 4
Total lesion count	Percent change in Global Face Total Lesion Count	From baseline to week 8
Total lesion count	Percent change in Global Face Total Lesion Count	From baseline to week 12
IGA score	IGA score of zero (clear) or one (almost clear) as compared to vehicle	From baseline to week 2, 4, 8, 12
IGA score	IGA score of zero (clear) or one (almost clear)	From baseline to week 4
IGA score	IGA score of zero (clear) or one (almost clear)	From baseline to week 8
IGA score	IGA score of zero (clear) or one (almost clear)	From baseline to week 12
IGA score	IGA score of zero (clear) or one (almost clear) as compared to vehicle	From baseline to week 2, 4, 8 & 12
Inflammatory and non-inflammatory leisons	Percent reductions in facial lesion counts for inflammatory and noninflammatory	From baseline to week 2
Inflammatory and non-inflammatory leisons	Percent reductions in facial lesion counts for inflammatory and noninflammatory	From baseline to week 4
Inflammatory and non-inflammatory leisons	Percent reductions in facial lesion counts for inflammatory and noninflammatory	From baseline to week 8
Inflammatory and non-inflammatory leisons	Percent reductions in facial lesion counts for inflammatory and noninflammatory	From baseline to week 12
Inflammatory and non-inflammatory leisons	Percent reductions in facial lesion counts for inflammatory and noninflammatory as compared to vehicle	From baseline to week 2, 4, 8 & 12
Post inflammatory hyperpigmentation	Percent reduction in overall post inflammatory hyperpigmentation	From baseline to week 2
Post inflammatory hyperpigmentation	Percent reduction in overall post inflammatory hyperpigmentation	From baseline to week 4
Post inflammatory hyperpigmentation	Percent reduction in overall post inflammatory hyperpigmentation	From baseline to week 8
Post inflammatory hyperpigmentation	Percent reduction in overall post inflammatory hyperpigmentation	From baseline to week 12
Post inflammatory hyperpigmentation	Percent reduction in overall post inflammatory hyperpigmentation as compared to vehicle	From baseline to week 2, 4, 8 & 12

Collaborators and Investigators

• Sponsor: Ratan K. Chaudhuri
• Investigators: Principal Investigator: Barrie Drewitt, Princeton Consumer Research

Study record dates

Study Major Dates

• Study Start (Actual): September 10, 2021
• Primary Completion (Anticipated): February 20, 2022
• Study Completion (Anticipated): January 30, 2025

Study Registration Dates

• First Submitted: September 23, 2021
• First Submitted That Met QC Criteria: October 5, 2021
• First Posted (Actual): October 6, 2021

Study Record Updates

• Last Update Posted (Actual): October 6, 2021
• Last Update Submitted That Met QC Criteria: October 5, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Acneiform Eruptions; Sebaceous Gland Diseases; Acne Vulgaris
• Other Study ID Numbers: SYTPIG1M

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: No plan on sharing IPD to other researchers

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No