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

  • STATUS
    Recruiting
  • End date
    Jan 30, 2025
  • participants needed
    40
  • sponsor
    Ratan K. Chaudhuri
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Updated on 14 October 2021
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Accepts healthy volunteers

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.

Details
Condition Acne Vulgaris, Acne, Non-inflammatory Comedones, acnes, Inflammatory Comedones
Treatment Vehicle, Bakuchiol and Ethyl Linoleate
Clinical Study IdentifierNCT05069272
SponsorRatan K. Chaudhuri
Last Modified on14 October 2021

Eligibility

 Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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