Trial studying safety and effects for Acne Vulgaris
Official title Study to Assess Safety, Pharmacokinetics, and Treatment Effect of Cabtreo
ClinicalTrials.gov ID: NCT07524946
What this study is testing
What is CABTREO is a fixed-combination product of clindamycin phosphate 1.2%/BPO 3.1%/adapalene 0.15%.?
CABTREO is a fixed-combination product of clindamycin phosphate 1.2%/BPO 3.1%/adapalene 0.15%. is an investigational medicine, given as a treatment applied to the skin, being studied as a potential treatment for acne vulgaris.
Also referred to as IDP-126.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 9 to 11
You may be able to join if
- 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...
- 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
You likely can't join if
- 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...
- Any underlying disease(s) or other dermatological condition of the face that requires the use of interfering topical or systemic therapy, or makes...
- Participants with \> 2 facial nodules at baseline
- Evidence or history of cosmetic-related acne
See the full eligibility criteria
Who can join
- 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...
- 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...
- 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...
What rules you out
- 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...
- 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...
- 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...
- 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 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
The study team makes the final eligibility decision.
Where it's taking place
- Bryant, Arkansas, United States
- Rogers, Arkansas, United States
- Freemont, California, United States
- Manhattan Beach, California, United States
- North Miami Beach, Florida, United States
- Tampa, Florida, United States
- Louisville, Kentucky, United States
- Clinton Township, Michigan, United States
- Las Vegas, Nevada, United States
- Stony Brook, New York, United States
- Woodbury, New York, United States
- Apex, North Carolina, United States
- Oklahoma City, Oklahoma, United States
- Gresham, Oregon, United States
- Spokane, Washington, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 9 years to 11 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bryant, Arkansas, United States; Rogers, Arkansas, United States; Freemont, California, United States; Manhattan Beach, California, United States; North Miami Beach, Florida, United States; Tampa, Florida, United States and 9 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.