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Study Comparing Test to Aczone 7.5% and Both to a Placebo Control in the Treatment of Acne Vulgaris

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ClinicalTrials.gov Identifier: NCT04015375
Recruitment Status : Recruiting
First Posted : July 11, 2019
Last Update Posted : July 23, 2019
Sponsor:
Collaborator:
Catawba Research
Information provided by (Responsible Party):
Torrent Pharmaceuticals Limited

Brief Summary:
To evaluate the therapeutic effect of Dapsone and Placebo gel in the treatment of acne vulgaris.

Condition or disease Intervention/treatment Phase
Acne Vulgaris Drug: Dapsone gel 7.5% (Torrent Pharmaceuticals Ltd) Drug: ACZONE® (dapsone) gel, 7.5% (Allergan, INC.) Other: Placebo for Dapsone gel 7.5% (Torrent Pharmaceuticals Ltd) Phase 3

Detailed Description:
A Multicenter, Double Blind, Randomized, Placebo Controlled, Parallel Group study comparing Dapsone to ACZONE Gel and active treatment to a Placebo control in the treatment of Acne Vulgaris

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: A multi-center, double-blind, randomized, three-arm, placebo-controlled, parallel-group study
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Double blind, Randomised
Primary Purpose: Treatment
Official Title: A Multi-center,Double-blind,Randomized,Three-arm,Placebo-controlled,Parallel-group Study, Comparing Dapsone Gel,7.5% (Torrent Pharma) to Aczone® Gel,7.5% and Both Active Treatments to a Placebo Control in the Treatment of Acne Vulgaris
Estimated Study Start Date : July 2019
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : April 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne
Drug Information available for: Dapsone

Arm Intervention/treatment
Experimental: Dapsone gel, 7.5% (Torrent Pharmaceuticals Ltd.)
Topical, once daily for 84 days
Drug: Dapsone gel 7.5% (Torrent Pharmaceuticals Ltd)
Topical gel

Active Comparator: ACZONE® (dapsone) gel, 7.5% (Allergan, INC.)
Topical, once daily for 84 days
Drug: ACZONE® (dapsone) gel, 7.5% (Allergan, INC.)
Topical gel

Placebo Comparator: Placebo for Dapsone gel 7.5% (Torrent Pharmaceuticals Ltd)
Topical, once daily for 84 days
Other: Placebo for Dapsone gel 7.5% (Torrent Pharmaceuticals Ltd)
Topical gel




Primary Outcome Measures :
  1. Change in inflammatory lesion counts [ Time Frame: 12 weeks ]
    Mean percent change from baseline to week 12 in the inflammatory (papules and pustules) lesion counts

  2. Change in non-inflammatory counts lesion counts [ Time Frame: 12 weeks ]
    Mean percent change from baseline to week 12 in the non-inflammatory (open and closed comedones) lesion counts



Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 40 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Healthy male or non-pregnant female aged ≥ 12 and ≤ 40 years with a clinical diagnosis of acne vulgaris.
  2. Subjects who are 18 years of age or older (up to the age of 40 inclusive) must have provided IRB approved written informed consent. Subjects ages 12 to 17 years of age inclusive must have provided IRB approved written assent; this written assent must be accompanied by an IRB approved written informed consent from the Subject's legally acceptable representative (i.e., parent or guardian). In addition, all Subjects or their legally acceptable representatives (i.e., parent or guardian) must sign a HIPAA authorization.
  3. Subjects must have a minimum ≥ 25 non-inflammatory lesions (i.e., open and closed comedones) AND ≥ 20 inflammatory lesions (i.e., papules and pustules) AND ≤ 2 nodulocystic lesions (i.e., nodules and cysts), at baseline on the face. For the purposes of study treatment and evaluation, these lesions should be limited to the facial treatment area. All lesions will be counted, including those present on the nose. Subjects may have acne lesions on other areas of the body which will also be excluded from the count, treatment, and the Investigator's Global Assessment (IGA) evaluation (e.g., on the back, chest and arms).
  4. Subjects must have a definite clinical diagnosis of acne vulgaris of severity grade 2, 3, or 4 as per the Investigator's Global Assessment (IGA).
  5. Subjects must be willing to refrain from using all other topical acne medications or antibiotics during the 12-week treatment period for acne vulgaris, other than the Investigational Product.
  6. Female Subjects of childbearing potential (excluding women who are premenarchal, surgically sterilized or postmenopausal for at least 1 year), in addition to having a negative urine pregnancy test, must be willing to use an acceptable form of birth control during the study from the day of the first dose administration to 30 days after the last administration of study drug . For the purpose of this study the following are considered acceptable methods of birth control: oral or injectable contraceptives, contraceptive patches, Depo-Provera® (stabilized for at least 3 months) NuvaRing® (vaginal contraceptive);Implanon™ (contraceptive implant), double barrier methods (e.g. condom and spermicide),Intrauterine Device (IUD), Essure, or abstinence. If a subject who was abstinent becomes sexually active during the study, a 2nd acceptable method of birth control should be documented. A sterile sexual partner is NOT considered an adequate form of birth control. Hormonal contraceptives should not be initiated or changed during the study.
  7. All male Subjects must agree to use accepted methods of birth control with their partners, from the day of the first dose administration to 30 days after the last administration of study drug. Abstinence is an acceptable method of birth control. Female partners should use an acceptable method of birth control as described in the above Item Number 6.
  8. Subjects must be willing and able to understand and comply with the requirements of the protocol, including attendance at the required study visits.
  9. Subjects must be in good health and free from any clinically significant disease, including but not limited to, conditions that may interfere with the evaluation of acne vulgaris. Such conditions include, but are not limited to the following: autoimmune disease, rosacea; seborrheic dermatitis; perioral dermatitis; corticosteroid-induced acne; carcinoid syndrome; mastocytosis; acneiform eruptions caused by make-up, medication, facial psoriasis and facial eczema.
  10. Subjects who use make-up must have used the same brands/types of make-up for a minimum period of 14 days prior to study entry and must agree to not change make-up brand/type or frequency of use throughout the study.

Exclusion Criteria:

  1. Female Subjects who are pregnant, nursing or planning to become pregnant during study participation.
  2. Subjects with a history of hypersensitivity or allergy to dapsone and/or any of the study medication ingredients and its excipients.
  3. Subjects with the presence of any skin condition that would interfere with the diagnosis or assessment of acne vulgaris (e.g., on the face: rosacea, dermatitis, psoriasis, squamous cell carcinoma, eczema, acneiform eruptions caused by medications, steroid acne, steroid folliculitis, or bacterial folliculitis).
  4. Subjects with excessive facial hair (e.g. beards, sideburns, moustaches, etc.) that would interfere with diagnosis or assessment of acne vulgaris.
  5. Subjects who have performed wax depilation of the face within 14 days prior to baseline.
  6. Subjects who have used within 6 months prior to baseline or use during the study of oral retinoids (e.g. Accutane®), or therapeutic vitamin A supplements of greater than 10,000 units/day (multivitamins are allowed).
  7. Subjects who have used estrogens or oral contraceptives for less than 3 months prior to baseline; use of such therapy must remain constant throughout the study.
  8. Subjects who have used any of the following procedures on the face within 1 month prior to baseline or use during the study:

    1. cryodestruction or chemodestruction,
    2. dermabrasion,
    3. photodynamic therapy,
    4. acne surgery,
    5. intralesional steroids, or
    6. X-ray therapy.
  9. Subjects who have used any of the following treatments within 1 month prior to baseline or during the study:

    1. systemic steroids,
    2. spironolactone,
    3. systemic antibiotics,
    4. systemic treatment for acne vulgaris (other than oral retinoids, which require a 6-month washout), or
    5. systemic anti-inflammatory agents
  10. Subjects who have used any of the following treatments within 2 weeks prior to baseline or during the study:

    1. topical steroids,
    2. topical retinoids,
    3. topical acne treatments including over-the-counter preparations,
    4. topical anti-inflammatory agents, or
    5. topical antibiotics.
  11. Subjects who have received radiation therapy and/or anti-neoplastic agents within 90 days prior to baseline.
  12. Subjects who have unstable medical disorders that are clinically significant or have lifethreateningdiseases.
  13. Subjects who have on-going malignancies requiring systemic treatment will be excluded from study participation. In addition, Subjects who have any malignancy of the skin of the facial area will also be excluded.
  14. Subjects who engage in activities that involve excessive or prolonged exposure to sunlight or weather extremes, such as wind or cold.
  15. Subjects who consume excessive amounts of alcohol (greater than two drinks per day) or of drugs of abuse (including, but not limited to, cannabinoids, cocaine and barbiturates).
  16. Subjects who have participated in an investigational drug study (i.e., Subjects have been treated with an investigational drug) within 30 days prior to baseline will be excluded from study participation. Subjects who are participating in non-treatment studies such as observational studies or registry studies can be considered for inclusion.
  17. Subjects who have been previously enrolled in this study.
  18. Subjects who have had laser therapy, electrodesiccation and phototherapy (e.g., ClearLight®) to the facial area within 180 days prior to study entry.
  19. Subjects who have had cosmetic procedures (e.g., facials) which may affect the efficacy and safety profile of the investigational product within 14 days prior to study entry. Cosmetic procedures and facials are prohibited throughout the study.
  20. Subjects who currently have or have recently had bacterial folliculitis on the face.
  21. Subjects with a baseline irritation score of 3 = severe (marked, intense).
  22. Subjects with known G6PD deficiency, or congenital or idiopathic methemoglobinemia.

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): NCT04015375


Contacts
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Contact: Sanjay Sharma, MD +91-79-2969100 ext 193 sanjaysharma@torrentpharma.com

Locations
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United States, California
Unison Center for Clinical Trials Not yet recruiting
Sherman Oaks, California, United States, 91403
Contact: Fernell Romero    818-981-1555 ext 206    fromero@unisonclinicaltrials.com   
Contact: Jessica Ortiz    818-981-1555 ext 244    jortiz@sjacobsmd.com   
Principal Investigator: Shahram Jacobs, MD         
United States, Florida
MOORE Clinical Research, Inc. Recruiting
Brandon, Florida, United States, 33511
Contact: Judy Keene    813-948-7550 ext 302    jkeene@moorecr.com   
Contact: Elizabeth Juneja    813-948-7550 ext 302    ejuneja@moorecr.com   
Principal Investigator: Scott Miller, MD         
FXM Clinical Research Miami Not yet recruiting
Miami, Florida, United States, 33175
Contact: Maritza D Diego    305-220-5222    maritza.d.diego@fxmresearch.com   
Contact: Francisco Moncada    305-220-5222    francisco.moncada@fxmresearch.com   
Principal Investigator: Hector Wiltz, MD         
FXM Clinical Research Miramar Not yet recruiting
Miramar, Florida, United States, 33027
Contact: Maritza D Diego    954-430-1097    maritza.d.diego@fxmresearch.com   
Contact: Francisco Moncada    954-430-1097    francisco.moncada@fxmresearch.com   
Principal Investigator: Francisco Flores, MD         
MOORE Clinical Research, Inc. (S. Tampa Site) Recruiting
Tampa, Florida, United States, 33609
Contact: Theresa Lopez    813-948-7550 ext 402    tlopez@moorecr.com   
Contact: Johanna Castellanos    813-948-7550 ext 409    jcastellanos@moorecr.com   
Principal Investigator: Scott Miller, MD         
MOORE Clinical Research, Inc. (Temple Terrace Site) Not yet recruiting
Temple Terrace, Florida, United States, 33617
Contact: Judy Keene    813-948-7550 ext 302    jkeene@moorecr.com   
Contact: Elizabeth Juneja    813-948-7550 ext 302    ejuneja@moorecr.com   
Principal Investigator: Scott Miller, MD         
Research Institute of Central Florida Recruiting
Winter Park, Florida, United States, 72792
Contact: Mansura YASMIN Moledina    407-543-3461 ext 5    yasmin@cflresearch.com   
Contact: Ariel McCubbin    407-543-3461    ariel.mcresearch@gmail.com   
Principal Investigator: Gregory Samano, DO         
United States, North Carolina
Dermatology Consulting Services, PLLC Not yet recruiting
High Point, North Carolina, United States, 27262
Contact: Crystal Williams    336-841-2040    dcs11@northstate.net   
Contact: Jennifer Huth    336-841-2040    dcs10@northstate.net   
Principal Investigator: Zoe Draelos, MD         
United States, Pennsylvania
PEAK Research, LLC Not yet recruiting
Upper Saint Clair, Pennsylvania, United States, 15241
Contact: Kathy Tracy    412-595-7681    tracyk@peak-research.com   
Contact: Lori Tobasco    412-595-7681    tobascol@peak-research.com   
Principal Investigator: James M Moretti, MD         
United States, Texas
3A Research, LLC - WEST Recruiting
El Paso, Texas, United States, 79902
Contact: Gerardo Padilla    915-745-8000    gerardo@3asites.com   
Contact: Juanita Villarreal    915-745-8000    juanita@3asites.com   
Principal Investigator: Aldo Maspons, MD         
3A Research, LLC - EAST Not yet recruiting
El Paso, Texas, United States, 79925
Contact: Karen Salas    915-598-8888    karen@3asites.com   
Contact: Juan Martinez    915-598-8888    juan@3asites.com   
Principal Investigator: Aldo Maspons, MD         
Belize
Dermatology & Skin Surgery Centre/ FXM Research International Not yet recruiting
Belize City, Belize
Contact: Francisco Moncada    (786) 590-1567    francisco.moncada@fxmresearch.com   
Contact: Maritza D Diego    (786) 590-1567    maritza.d.diego@fxmresearch.com   
Principal Investigator: Julitta M Bradley, MD         
Dr. Moguel's Clinic/ FXM Research International Not yet recruiting
Belize City, Belize
Contact: Francisco Moncada    (786) 590-1567    francisco.moncada@fxmresearch.com   
Contact: Maritza D Diego    (786) 590-1567    maritza.d.diego@fxmresearch.com   
Principal Investigator: Ines Mendez-Moguel, MD         
Sponsors and Collaborators
Torrent Pharmaceuticals Limited
Catawba Research
Investigators
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Study Chair: Caryn Thompson, MBA Catawba Research

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Responsible Party: Torrent Pharmaceuticals Limited
ClinicalTrials.gov Identifier: NCT04015375     History of Changes
Other Study ID Numbers: DPSG 1812
First Posted: July 11, 2019    Key Record Dates
Last Update Posted: July 23, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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.: No

Keywords provided by Torrent Pharmaceuticals Limited:
acne vulgaris

Additional relevant MeSH terms:
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Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases
Dapsone
Anti-Infective Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Folic Acid Antagonists
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Leprostatic Agents
Anti-Bacterial Agents