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

Not Applicable

Recruiting

• Conditions: Acne Vulgaris
• Interventions: Other: Bakuchiol and Ethyl Linoleate; Other: Vehicle

• Registration Number: NCT05069272
• Lead Sponsor: Ratan K. Chaudhuri

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-09-10
• Study First Submitted: 2021-09-23
• Status Verified: 2021-10
• Study First Submitted QC: 2021-10-05
• Last Update Submitted: 2021-10-05
• Study First Posted: 2021-10-06
• Last Update Posted: 2021-10-06
• Primary Completion: 2022-02-20
• Study Completion: 2025-01-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Bakuchiol and Ethyl Linoleate	Synergistic combination of Bakuchiol and Ethyl Linoleate
Vehicle	Vehicle	No active ingredients

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Princeton Consumer Research Corp; 🇬🇧 Chelmsford, England, United Kingdom