Louisville, KYNCT07524946Now EnrollingIRB Ready

Acne Vulgaris Clinical Trial in Louisville, KY

Access cutting-edge acne vulgaris treatment through this phase 4 clinical trial at a research site in Louisville. Study-provided care at no cost to qualified participants.

Sponsored by Bausch Health Americas, Inc.

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Expert Care in Louisville

Access acne vulgaris specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related acne vulgaris treatment provided free

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Check if you qualify for this acne vulgaris clinical trial in Louisville, KY

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Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Local to Louisville

    Convenient for KY residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Louisville site if eligible
  4. 4Begin participation

About This Acne Vulgaris Study in Louisville

This study is to evaluate the safety, pharmacokinetics, and treatment effect for topically applied CABTREO lotion in pediatric participants ages 9 to 11 years, 11 months with Acne Vulgaris.

Sponsor: Bausch Health Americas, Inc.

Who Can Participate

Inclusion Criteria

A participant will be eligible for inclusion if he/she meets all the following criteria:
Male or female participants, ≥ 9 years of age and ≤ 11 years, 11 months of age at baseline
Participants must provide verbal and signed, written informed consent; participants less than the age of consent must sign an assent for the study and a parent/legal guardian must sign the informed consent
Participants must have a score of 3 (moderate) or 4 (severe) on the EGSS assessment at baseline
Participants must have a facial acne inflammatory lesion (papules, pustules, and nodules) count ≥ 30 at baseline
Participants must have a facial acne noninflammatory lesion (open and closed comedones) count ≥ 35 at baseline
Participants must have acne lesions in at least 1 truncal region (ie, on the chest, back, and/or shoulder) at baseline
Participants must have ≤ 2 facial nodules at baseline
Women of childbearing potential and female participants who are premenses (≥ 9 years of age) must be willing to practice effective contraception for the duration of the study. Effective contraception is defined as being stabilized on an oral contraceptive for at least 3 months; using an intrauterine device/system, condom with spermicide, diaphragm with spermicide, implant, NuvaRing®, injection, transdermal patch; bilateral tubal ligation; vasectomized partner; or practicing abstinence. Females on birth control pills must have taken the same type of pill for at least 3 months prior to entering the study and must not change types during the study. Those who have used birth control pills in the past must have discontinued use at least 3 months prior to the start of the study. Those who use birth control for acne control only should be excluded.
Premenses females and women of childbearing potential must have a negative urine pregnancy test at screening and baseline, and must have a negative serum pregnancy test at screening.
Participants must be willing to comply with study instructions and return to the study center for required visits; participants under the age of consent must be accompanied by the parent/legal guardian at the time of providing assent/consent
If a cleanser, moisturizer or sunscreen is needed during the study, participants must be willing to use only allowed cleansers, moisturizers, sunscreens, or moisturizer/sunscreen combination products; the participant must agree to use noncomedogenic products (including makeup and shaving products) Use of an investigational drug or device within 30 days of enrollment or participation in a research study concurrent with this study

Exclusion Criteria

A participant will not be eligible for inclusion if any of the following criteria apply:
Use of an investigational drug or device within 30 days of enrollment or participation in a research study concurrent with this study
Any dermatological conditions on the face that could interfere with clinical evaluations such as acne conglobata, acne fulminans, secondary acne, perioral dermatitis, clinically significant rosacea, gram-negative folliculitis, dermatitis, and/or eczema
Any underlying disease(s) or other dermatological condition of the face that requires the use of interfering topical or systemic therapy, or makes evaluations and lesion counts inconclusive
Participants with \> 2 facial nodules at baseline
Evidence or history of cosmetic-related acne
Participants with a history of experiencing significant burning or stinging when applying any facial treatment (eg, makeup, soap, masks, washes, sunscreens) to the face
Female participants who are pregnant, nursing mothers, planning a pregnancy during the course of the study, or become pregnant during the study
Use of estrogens (eg, Depogen, Depo-Testadiol, Gynogen, Valergen) for less than 12 weeks immediately preceding study entry; a participant who is treated with estrogens for ≥ 12 consecutive weeks immediately prior to study entry need not be excluded unless the participant expects to change the dose, the drug, or discontinue estrogen use during the study
If female, participant has a history of hirsutism, polycystic ovarian disease, or clinically significant menstrual irregularities
History of regional enteritis, ulcerative colitis, inflammatory bowel disease, pseudomembranous colitis, chronic or recurrent diarrhea, or antibiotic-associated colitis
Treatment of any type of cancer within the 6 months prior to screening, with the exception of complete surgical excision of skin cancer outside the treatment area
Participant uses medications and/or vitamins during the study that are reported to exacerbate acne (azathioprine, haloperidol, Vitamin D, Vitamin B12, halogens such as iodides or bromides, lithium, systemic or topical mid- to super-high potency corticosteroids on the treatment area, phenytoin, and phenobarbital); multivitamins, including Vitamin A, at recommended daily doses, and Vitamin D at stable doses, are acceptable
History of hypersensitivity or allergic reactions to any of the study preparations as described in the Investigator's Brochure, including known sensitivities to any dosage form of clindamycin phosphate, BPO, or adapalene
Concomitant use of potentially irritating over the counter products that contain ingredients such as BPO, alpha-hydroxy acid, salicylic acid, retinol, or glycolic acids
Participants who have not undergone the specified washout period(s) for the following topical preparations or physical treatments used on the face or participants who require the concurrent use of any of the following topical agents in the treatment area:
Topical astringents and abrasives (including comedo removal strips) on the face -1 week
Nonallowed moisturizers or sunscreens on the face -1 week
Antibiotics on the face -2 weeks
Other topical anti-acne drugs on the face -2 weeks
Soaps containing antimicrobials on the face -2 weeks
Anti-inflammatory agents and corticosteroids on the face -4 weeks
Retinoids, including retinol, on the face -4 weeks
Facial procedures, including chemical peel, microdermabrasion, light (eg, PDT, LED) and laser therapy, and acne surgery -4 weeks
Participants who have not undergone the specified washout period(s) for the following systemic medications or participants who require the concurrent use of any of the following systemic medications:
Corticosteroids (including intramuscular injections) (inhaled corticosteroids allowed) -4 weeks
Antibiotics -4 weeks
Other systemic acne treatments -4 weeks
Systemic retinoids -6 months
Participants who intend to use a tanning booth or sunbathe during the study
Participants who are unable to communicate or cooperate with the investigator due to language problems, poor mental development, or impaired cerebral function
Participants who have any underlying disease the investigator deems uncontrolled, and that poses a concern for the participant's safety while participating in the study

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Louisville?

Yes, this clinical trial (NCT07524946) has an active research site in Louisville, KY that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Acne Vulgaris Treatment Options in Louisville, KY

If you're searching for acne vulgaris treatment options in Louisville, KY, this clinical trial (NCT07524946) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Louisville research site is actively enrolling participants for this phase 4 clinical trial. You'll receive care from experienced acne vulgaris specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all acne vulgaris clinical trials near you to find additional studies recruiting in your area.

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