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

NCT04940767 | Completed Phase 4 FDA Drug

• 1 other identifier: V77-123
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 2

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.

Conditions

Acne Vulgaris

Outcome Measures

Primary Outcomes (2)

• Lesion Improvement

  Percent change from Baseline in inflammatory and comedonal lesion counts at each visit.

  44 weeks

• IGA Improvement

  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.

  44 weeks

Study Arms (2)

Treatment Group A

EXPERIMENTAL

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; Drug: Amzeeq 4% Topical Foam

Treatment Group B

EXPERIMENTAL

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; Drug: Amzeeq 4% Topical Foam

Interventions

Isotretinoin DRUG

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®.

Also known as: Zenatane™

Treatment Group A; Treatment Group B

Amzeeq 4% Topical Foam DRUG

AMZEEQ® is a topical lipophilic foam containing 4% minocycline that was approved in the US for the treatment of acne vulgaris in 2019

Also known as: minocycline

Treatment Group A; Treatment Group B

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Is 12 years of age or older.
• Has facial acne vulgaris with an IGA score of moderate (3) or severe (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.
• If female of child-bearing potential (FOCBP), must have two negative pregnancy tests, one being serologic, within the screening period.
• 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).
• 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.
• 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.
• 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.

You may not qualify if:

• Patients who meet any of the following will be excluded from the study:
• Female who is pregnant, lactating or breastfeeding, or is planning a pregnancy during the study.
• 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.
• Sunburn on the face.
• Severe systemic disease that might interfere with the conduct of the study or the interpretation of the results.
• Abnormal Screening laboratory values that are considered clinically significant.
• 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.
• Patient, who in the opinion of the investigator, is unable or unlikely to comply with the requirements of the study protocol.
• 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)
• Patients who have used the following medications (topical refers only to the facial area) will not be eligible:
• Within 1 week prior to randomization:

Sponsors & Collaborators

• Edward Lain, MD: lead
• Vyne Therapeutics Inc.: collaborator

Study Sites (2)

Austin Institute for Clinical Research, Inc.

Dripping Springs, Texas, 78620, United States

Location

Austin Institute for Clinical Research, Inc.

Pflugerville, Texas, 78660, United States

Location

Related Publications (13)

• Brown SK, Shalita AR. Acne vulgaris. Lancet. 1998 Jun 20;351(9119):1871-6. doi: 10.1016/S0140-6736(98)01046-0. No abstract available.

  PMID: 9652685 RESULT

• AMZEEQ® Prescribing Information - accessed March 10th 2021.

  RESULT

• Raoof TJ, Hooper D, Moore A, Zaiac M, Sullivan T, Kircik L, Lain E, Jankicevic J, Stuart I. Efficacy and safety of a novel topical minocycline foam for the treatment of moderate to severe acne vulgaris: A phase 3 study. J Am Acad Dermatol. 2020 Apr;82(4):832-837. doi: 10.1016/j.jaad.2019.05.078. Epub 2019 Jun 1.

  PMID: 31163231 RESULT

• Jones TM, Ellman H, deVries T. Pharmacokinetic Comparison of Once-Daily Topical Minocycline Foam 4% vs Oral Minocycline for Moderate-to-Severe Acne. J Drugs Dermatol. 2017 Oct 1;16(10):1022-1028.

  PMID: 29036256 RESULT

• Accutane® Prescribing Information - access March 10th 2021.

  RESULT

• Fogh K, Voorhees JJ, Astrom A. Expression, purification, and binding properties of human cellular retinoic acid-binding protein type I and type II. Arch Biochem Biophys. 1993 Feb 1;300(2):751-5. doi: 10.1006/abbi.1993.1104.

  PMID: 8382035 RESULT

• Allenby G, Bocquel MT, Saunders M, Kazmer S, Speck J, Rosenberger M, Lovey A, Kastner P, Grippo JF, Chambon P, et al. Retinoic acid receptors and retinoid X receptors: interactions with endogenous retinoic acids. Proc Natl Acad Sci U S A. 1993 Jan 1;90(1):30-4. doi: 10.1073/pnas.90.1.30.

  PMID: 8380496 RESULT

• 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.

  RESULT

• Ott F, Bollag W, Geiger JM. Oral 9-cis-retinoic acid versus 13-cis-retinoic acid in acne therapy. Dermatology. 1996;193(2):124-6. doi: 10.1159/000246226.

  PMID: 8884148 RESULT

• Geiger JM, Hommel L, Harms M, Saurat JH. Oral 13-cis retinoic acid is superior to 9-cis retinoic acid in sebosuppression in human beings. J Am Acad Dermatol. 1996 Mar;34(3):513-5. doi: 10.1016/s0190-9622(96)90462-4. No abstract available.

  PMID: 8609271 RESULT

• Tsukada M, Schroder M, Roos TC, Chandraratna RA, Reichert U, Merk HF, Orfanos CE, Zouboulis CC. 13-cis retinoic acid exerts its specific activity on human sebocytes through selective intracellular isomerization to all-trans retinoic acid and binding to retinoid acid receptors. J Invest Dermatol. 2000 Aug;115(2):321-7. doi: 10.1046/j.1523-1747.2000.00066.x.

  PMID: 10951254 RESULT

• Nelson AM, Gilliland KL, Cong Z, Thiboutot DM. 13-cis Retinoic acid induces apoptosis and cell cycle arrest in human SEB-1 sebocytes. J Invest Dermatol. 2006 Oct;126(10):2178-89. doi: 10.1038/sj.jid.5700289. Epub 2006 Mar 30.

  PMID: 16575387 RESULT

• Tantibanchachai C, Isotretinoin (Accutane) as a teratogen, Embryo Project Encyclopedia. 2014; ISSN: 1940-5030; http://embryo.asu.edu/handle/10776/8040

  RESULT

Related Links

• Tantibanchachai C, Isotretinoin (Accutane) as a teratogen, Embryo Project Encyclopedia.

MeSH Terms

Conditions

Acne Vulgaris

Interventions

Isotretinoin; Minocycline

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Intervention Hierarchy (Ancestors)

Retinoids; Carotenoids; Polyenes; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Cyclohexenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Pigments, Biological; Biological Factors; Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Polycyclic Compounds

Study Officials

• Edward Lain, MD, MBA

  Austin Institute for Clinical Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Study evaluators will be blinded to patient treatment group allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator/Executive Director

Study Record Dates

• First Submitted: June 16, 2021
• First Posted: June 28, 2021
• Study Start: June 28, 2021
• Primary Completion: April 28, 2023
• Study Completion: April 28, 2023
• Last Updated: June 22, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)