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

NCT05069272 | Unknown

• 1 other identifier: SYTPIG1M
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Acne Vulgaris

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (19)

• Total lesion count

  From baseline to week 2

• Total lesion count

  From baseline to week 4

• Total lesion count

  From baseline to week 8

• Total lesion count

  From baseline to week 12

• IGA score

  From baseline to week 2, 4, 8, 12

Study Arms (2)

Intervention

ACTIVE COMPARATOR

Synergistic combination of Bakuchiol and Ethyl Linoleate

Other: Bakuchiol and Ethyl Linoleate

Vehicle

PLACEBO COMPARATOR

No active ingredients

Other: Vehicle

Interventions

Bakuchiol and Ethyl Linoleate OTHER

A synergistic combination of Bakuchiol and Ethyl Linoleate

Intervention

Vehicle OTHER

No actives

Vehicle

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ratan K. Chaudhuri: lead

Study Sites (1)

Princeton Consumer Research Corp

Chelmsford, England, CM2 6UA, United Kingdom

RECRUITING

MeSH Terms

Conditions

Acne Vulgaris

Interventions

bakuchiol; ethyl linoleate

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Study Officials

• Barrie Drewitt

  Princeton Consumer Research

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jack Donnelly

CONTACT

44(0)1617911797; jack@princetonconsumer.com

Terrie Bennett

CONTACT

44(0)1245 934050; Terrie@princetonconsumer.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: President

Study Record Dates

• First Submitted: September 23, 2021
• First Posted: October 6, 2021
• Study Start: September 10, 2021
• Primary Completion: February 20, 2022
• Study Completion: January 30, 2025
• Last Updated: October 6, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)