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

Purpose

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.

Condition

  • Acne Vulgaris

Eligibility

Eligible Ages
Between 9 Years and 11 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

A participant will be eligible for inclusion if he/she meets all the following criteria: 1. Male or female participants, ≥ 9 years of age and ≤ 11 years, 11 months of age at baseline 2. 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 3. Participants must have a score of 3 (moderate) or 4 (severe) on the EGSS assessment at baseline 4. Participants must have a facial acne inflammatory lesion (papules, pustules, and nodules) count ≥ 30 at baseline 5. Participants must have a facial acne noninflammatory lesion (open and closed comedones) count ≥ 35 at baseline 6. Participants must have acne lesions in at least 1 truncal region (ie, on the chest, back, and/or shoulder) at baseline 7. Participants must have ≤ 2 facial nodules at baseline 8. 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. 9. 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. 10. 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 11. 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: 1. Use of an investigational drug or device within 30 days of enrollment or participation in a research study concurrent with this study 2. 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 3. 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 4. Participants with > 2 facial nodules at baseline 5. Evidence or history of cosmetic-related acne 6. Participants with a history of experiencing significant burning or stinging when applying any facial treatment (eg, makeup, soap, masks, washes, sunscreens) to the face 7. Female participants who are pregnant, nursing mothers, planning a pregnancy during the course of the study, or become pregnant during the study 8. 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 9. If female, participant has a history of hirsutism, polycystic ovarian disease, or clinically significant menstrual irregularities 10. History of regional enteritis, ulcerative colitis, inflammatory bowel disease, pseudomembranous colitis, chronic or recurrent diarrhea, or antibiotic-associated colitis 11. 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 12. 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 13. 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 14. Concomitant use of potentially irritating over the counter products that contain ingredients such as BPO, alpha-hydroxy acid, salicylic acid, retinol, or glycolic acids 15. 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 16. 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 17. Participants who intend to use a tanning booth or sunbathe during the study 18. Participants who are unable to communicate or cooperate with the investigator due to language problems, poor mental development, or impaired cerebral function 19. 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

Study Design

Phase
Phase 4
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Other
All enrolled participants will receive CABTREO in this open-label study.
CABTREO is a fixed-combination product of clindamycin phosphate 1.2%/BPO 3.1%/adapalene 0.15%.
  • Drug: 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.
    Other names:
    • IDP-126

Recruiting Locations

Dermatology Trial Associates
Bryant, Arkansas 72002
Contact:
Dow Stough, MD
501-655-6138
dow@burketherapeutics.com

Northwest Arkansas Clinical Trials Center
Rogers, Arkansas 72758
Contact:
Cheryl Hull, MD
479-876-8205
drhull@hullderm.com

Center for Dermatology Clinical Research
Freemont, California 94538
Contact:
Sunil Dhawan, MD
510-797-0140
sdhawan@centerforderm.com

Ablon Skin Institute and Research Center
Manhattan Beach, California 90266
Contact:
Glynis Ablon, MD
310-727-3376
drablon@abloninstitute.com

Ziaderm Research, LLC
North Miami Beach, Florida 33162
Contact:
Tory Sullivan, MD
305-652-8600
drtory@sullivandermatology.com

Clinical Research Trials of Florida, Inc
Tampa, Florida 33607
Contact:
Sady Alpizar, MD
813-873-8102
s.alpizar.md@crtfi.com

DS Research of Kentucky, LLC
Louisville, Kentucky 40241
Contact:
Cindy Owen, MD
502-585-9059
cowen@dsrtrials.com

Michigan Center for Skin Care Research
Clinton Township, Michigan 48038
Contact:
Mary Veremis-Ley, MD
586-286-7325
mveremisley@docsdermgroup.com

JDR Dermatology Research
Las Vegas, Nevada 89145
Contact:
James Del Rosso, MD
702-331-4123
jqdelrosso@yahoo.com

DermResearchCenter of New York
Stony Brook, New York 11790
Contact:
Elyse Rafal, MD
631-689-1900
erafal@dcny.com

Vitality Clinical Trials, LLC
Woodbury, New York 11797
Contact:
Jeffrey Sklar, MD
917-647-3830
jeffrey.sklar@vitalityclinicaltrials.com

Lynn Health Science Institute
Oklahoma City, Oklahoma 73112
Contact:
Carl Griffin, MD
405-602-3927
Cgriffin@lhsi.net

Cyn3rgy Research Corporation
Gresham, Oregon 97030
Contact:
Frank Calcagno, MD
503-907-2179
fcalcagno@cyn3rgy.com

Breakaway Research Group
Spokane, Washington 99202
Contact:
William Werschler, MD
509-343-3710
Werschler@breakaway-research.com

More Details

Status
Recruiting
Sponsor
Bausch Health Americas, Inc.

Study Contact

Emily N Hughes, MACPR
731-415-3174
Emily.Hughes@BauschHealth.com

Detailed Description

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).