Study to Assess Safety, Pharmacokinetics, and Treatment Effect of Cabtreo

Официальное название

A 12-Week, Phase 4, Open-Label Study To Assess Safety, Pharmacokinetics, and Treatment Effect of CABTREO (Clindamycin Phosphate 1.2%, Adapalene 0.15%, and Benzoyl Peroxide 3.1%) Topical Gel In Pediatric Participants Ages 9 to 11 Years, 11 Month With Acne Vulgaris

Обзор

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.

Подробное описание

This is an open-label study designed to assess the safety, plasma PK, and treatment effect of topically applied CABTREO. This study includes both a main study and a PK sub-study. All participants will undergo a screening period of up to 5 weeks (up to 35 days) and a treatment period of up to 12 weeks (approximately 84 days). A subset of participants in the main study will be included in the PK sub-study. To be eligible for this study, participants must be between 9 years and 11 years, 11 months of age, inclusive, and have a clinical diagnosis of moderate to severe acne, defined as a score of 3 (moderate) or 4 (severe) on the Evaluator's Global Severity Score (EGSS). Participants must also have at least 30 facial acne inflammatory lesions, at least 35 facial acne noninflammatory lesions, and no more than 2 facial nodules; participants should also have acne lesions on at least 1 region of the trunk (chest, back, and/or shoulder).

Вмешательства

• Препарат CABTREO is a fixed-combination product of clindamycin phosphate 1.2%/BPO 3.1%/adapalene 0.15%.
  The study drug will be applied topically to the treatment areas at home, each the morning, for a period of 12 weeks, with the exception of study visit days (baseline \[Day 1\], and Days 14, 15 \[PK substudy only\], 28, 29 \[PK substudy only\], 56, and 84) where study drug will be applied by the participants after the study visit is completed at the study center. The study drug will be applied as a thin coating that is gently rubbed into the skin.

Первичные конечные точки

• Incidence of Treatment-Emergent Adverse Events [Срок оценки: All AEs will be followed from onset of the adverse event through the end of Study Week 12 visit]
• Change in Inflammatory Lesions [Срок оценки: Baseline through Week 12]
• Change in Non-inflammatory Lesions [Срок оценки: Baseline through Week 12]
• EGSS Results [Срок оценки: Baseline through Week 12]

Критерии участия

Критерии включения

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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 15 центров

• Dermatology Trial Associates — Bryant
• Northwest Arkansas Clinical Trials Center — Rogers
• Center for Dermatology Clinical Research — Freemont
• Ablon Skin Institute and Research Center — Manhattan Beach
• Ziaderm Research, LLC — North Miami Beach
• Clinical Research Trials of Florida, Inc — Tampa
• DS Research of Kentucky, LLC — Louisville
• Michigan Center for Skin Care Research — Clinton Township
• … и ещё 7 центров

Идентификаторы

NCT: NCT07524946 · V01-126A-401

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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