We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Companion Treatment Study for Patients With Moderate to Severe Acne Vulgaris

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04940767
Recruitment Status : Active, not recruiting
First Posted : June 28, 2021
Last Update Posted : March 23, 2022
Sponsor:
Collaborator:
Vyne Therapeutics Inc.
Information provided by (Responsible Party):
Edward Lain, MD, Austin Institute for Clinical Research

Brief Summary:
Acne vulgaris is a common disease of both males and females, usually manifesting initially during adolescence. The use of retinoic acid analogues such as adapalene, tazarotene and isotretinoin are also commonly prescribed to treat inflammation; dysregulated sebum production and comedonal acne. This study seeks to evaluate the efficacy and safety of concomitant use of both AMZEEQ® and oral isotretinoin compared to oral isotretinoin only use and to explore sequence dosing of both products as part of a long-term management protocol for acne vulgaris.

Condition or disease Intervention/treatment Phase
Acne Vulgaris Drug: Isotretinoin Drug: Amzeeq 4% Topical Foam Phase 4

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Masking Description: Study evaluators will be blinded to patient treatment group allocation.
Primary Purpose: Treatment
Official Title: A Prospective, Multicenter, Randomized, Evaluator-Blinded, Study to Evaluate the Safety and Efficacy of AMZEEQ® Companion Treatment With Oral Isotretinoin Therapy in Patients With Moderate to Severe Acne Vulgaris
Actual Study Start Date : June 28, 2021
Estimated Primary Completion Date : February 20, 2023
Estimated Study Completion Date : November 30, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne

Arm Intervention/treatment
Experimental: Treatment Group A
Patients will concomitantly receive once daily treatment of oral isotretinoin and topical AMZEEQ® for 20 weeks, followed by a further 24 weeks of once daily AMZEEQ® only treatment.
Drug: Isotretinoin
Isotretinoin is a retinoic acid analogue (13-cis-retinoic acid) supplied as oral capsules. and was approved in the US for the treatment of severe acne vulgaris in 1982 under the brand name Accutane®.
Other Name: Zenatane™

Drug: Amzeeq 4% Topical Foam
AMZEEQ® is a topical lipophilic foam containing 4% minocycline that was approved in the US for the treatment of acne vulgaris in 2019
Other Name: minocycline

Experimental: Treatment Group B
Patients will receive once daily treatment of oral isotretinoin for 20 weeks, followed by a further 24 weeks of once daily AMZEEQ® only treatment.
Drug: Isotretinoin
Isotretinoin is a retinoic acid analogue (13-cis-retinoic acid) supplied as oral capsules. and was approved in the US for the treatment of severe acne vulgaris in 1982 under the brand name Accutane®.
Other Name: Zenatane™

Drug: Amzeeq 4% Topical Foam
AMZEEQ® is a topical lipophilic foam containing 4% minocycline that was approved in the US for the treatment of acne vulgaris in 2019
Other Name: minocycline




Primary Outcome Measures :
  1. Lesion Improvement [ Time Frame: 44 weeks ]
    Percent change from Baseline in inflammatory and comedonal lesion counts at each visit.

  2. IGA Improvement [ Time Frame: 44 weeks ]
    IGA Treatment Success (dichotomized as Yes/No) at each visit, where success is defined as an IGA score of 0 or 1, and at least a 2-grade improvement (decrease) from Baseline.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Male or female patients will be considered eligible for participation in the study if all of the following inclusion criteria are satisfied prior to randomization:

  1. Has completed and signed an appropriately administered Informed Consent Form (ICF) prior to any study-related procedures. Patients less than 18 years of age (or as required by state law) must sign an Assent Form for the study and a parent or legal guardian must sign the ICF.
  2. Is 12 years of age or older.
  3. Has facial acne vulgaris with an IGA score of moderate (3) or severe (4).
  4. Is willing and able (with assistance from a caregiver as necessary) to both apply AMZEEQ® and take oral isotretinoin capsule(s) as directed, comply with study instructions, and commit to all follow-up visits for the duration of the study.
  5. If female of child-bearing potential (FOCBP), must have two negative pregnancy tests, one being serologic, within the screening period.
  6. Is willing to commit to true abstinence from heterosexual contact (which must be reviewed at each study visit and source documented) or agreed to use, and be able to comply with, effective contraception without interruption, prior to starting treatment as detailed below, during study period. For FOCBP who may participate in the study, the following methods of contraception, if properly used, are generally considered reliable with the following wait periods prior to having relations: oral contraceptives; vaginal contraceptive ring and patch contraceptives (one full cycle; e.g., 4 to 8 weeks); injection contraceptives (more than 7 days); intrauterine device or implantable hormone contraceptives (more than 7 days); surgical sterilization (bilateral tubal ligation) or a vasectomized partner (each, more than 6 months); male condom with intravaginal spermicide or diaphragm/cervical cap with spermicide (effective with proper use without a waiting period).
  7. If sexually active male patient, must practice true abstinence (which must be reviewed at each study visit) or agree to use a condom with intravaginal spermicide during sexual contact with a pregnant female or a FOCBP, while participating in the study, during dose interruptions, and for at least 30 days following treatment discontinuation, unless patient has undergone a successful vasectomy. Male patients should refrain from making sperm donations at any time during study participation and for at least 30 days following treatment discontinuation.
  8. Is willing to minimize exposure of the treated skin to ultraviolet light (e.g. avoid excessive sunlight, agree to not use tanning beds) and extremes in weather, such as wind or cold, throughout the study.
  9. In the investigator's opinion, patient is in good general health and is free of any disease state or physical condition that exposes the patient to an unacceptable risk by study participation or impairs the evaluation of the patient or the treatments by participating in the study.

Exclusion Criteria:

Patients who meet any of the following will be excluded from the study:

  1. Female who is pregnant, lactating or breastfeeding, or is planning a pregnancy during the study.
  2. Acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne), or any dermatological condition of the face (such as seborrhea, atopic dermatitis or basal cell carcinoma) that would require the use of confounding therapies or facial hair (eg, beard, sideburns, mustache) that could either interfere with clinical evaluations.
  3. Sunburn on the face.
  4. Severe systemic disease that might interfere with the conduct of the study or the interpretation of the results.
  5. Abnormal Screening laboratory values that are considered clinically significant.
  6. Patient is currently enrolled in another investigational drug or device study or is using or has used an investigational drug or investigational device treatment within 30 days of randomization.
  7. Patient, who in the opinion of the investigator, is unable or unlikely to comply with the requirements of the study protocol.
  8. Patients who have a history of any of the following will be excluded:

    • Allergy to tetracycline-class antibiotics or to any ingredient in the study drug
    • Pseudomembranous colitis or antibiotic-associated colitis
    • Hepatitis or liver damage or renal impairment
    • Known or suspected premalignant or malignant disease (excluding successfully treated skin cancers)
  9. Patients who have used the following medications (topical refers only to the facial area) will not be eligible:

    • Within 1 week prior to randomization:

      • Medicated facial cleansers
      • Topical acne treatments (other than those listed below)
    • Within 4 weeks prior to randomization:

      • Topical retinoids on the face
      • Topical anti-inflammatories eg, PDE-4 inhibitors, calcineurin inhibitors and corticosteroids on the face
      • Topical corticosteroids on body areas other than the face for more than 15 consecutive days and on more than 10% of body surface area. In flexural body areas, such as axillary and inguinal regions, only mild topical corticosteroids and allowed for short term use (≤15 consecutive days).
      • Systemic antibiotics
      • Systemic acne treatments
    • Within 12 weeks prior to randomization:

      • Systemic retinoids
      • Systemic corticosteroids (Note: Intranasal and inhaled corticosteroids may be used throughout the study).
  10. The following medications have been used less than the specified length of stable usage and patients must not initiate or change the dosing regimen during the course of the study: 3 months: hormonal contraceptives and therapies which also include testosterone replacement or supplementation.
  11. Patient has any acute illness (eg, infection) within 48 hours of randomization, which, in the investigator's opinion, is considered significant.
  12. Patient has a history of sensitivity to any of the ingredients in the medications.
  13. Documented history of depression or self-harm that is not, in the opinion of the Investigator, currently adequately controlled with medication or in remission. Or, the presence of significant uncontrolled neuropsychiatric disorder, are clinically judged by the investigator to be at risk for suicide, or have a "yes" answer to any of the following at Screening or Baseline:

    1. Question 4 (Active Suicidal Ideation with Some Intent to Act, Without Specific Plan) on the "Suicidal Ideation" portion of the Columbia Suicide Severity Rating Scale (C-SSRS) or
    2. Question 5 (Active Suicidal Ideation with Specific Plan and Intent) on the "Suicidal Ideation" portion of the C-SSRS or
    3. Any of the suicide-related behaviors (actual attempt, interrupted attempt, aborted attempt, preparatory act or behavior) on the "Suicidal Behavior"portion of the C-SSRS.

    Note: A patient does not necessarily have to be excluded if they have self-injurious behavior that would be classified as non-suicidal self-injurious behavior. If this situation arises, the subject should be referred to a psychiatrist or appropriately trained professional as indicated.

  14. Drug addiction or alcohol abuse (within the last 2 years).
  15. Patient has history of previous use of isotretinoin.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04940767


Locations
Layout table for location information
United States, Texas
Austin Institute for Clinical Research, Inc.
Dripping Springs, Texas, United States, 78620
Austin Institute for Clinical Research, Inc.
Pflugerville, Texas, United States, 78660
Sponsors and Collaborators
Edward Lain, MD
Vyne Therapeutics Inc.
Investigators
Layout table for investigator information
Principal Investigator: Edward Lain, MD, MBA Austin Institute for Clinical Research
Additional Information:
Publications of Results:
AMZEEQ® Prescribing Information - accessed March 10th 2021.
Accutane® Prescribing Information - access March 10th 2021.
Levin AA, Bosakowski T, Kazmer S, Grippo JF. 13-cis retinoic acid does not bind to retinoic acid receptors alpha, beta and gamma. Toxicologist. 1992; 12: 181.
Tantibanchachai C, Isotretinoin (Accutane) as a teratogen, Embryo Project Encyclopedia. 2014; ISSN: 1940-5030; http://embryo.asu.edu/handle/10776/8040

Layout table for additonal information
Responsible Party: Edward Lain, MD, Principal Investigator/Executive Director, Austin Institute for Clinical Research
ClinicalTrials.gov Identifier: NCT04940767    
Other Study ID Numbers: V77-123
First Posted: June 28, 2021    Key Record Dates
Last Update Posted: March 23, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
Layout table for MeSH terms
Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases
Minocycline
Isotretinoin
Anti-Bacterial Agents
Anti-Infective Agents
Dermatologic Agents