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A Safety and Efficacy Evaluation of Topical Treatments for Moderate-Severe Facial 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. Identifier: NCT02604680
Recruitment Status : Completed
First Posted : November 13, 2015
Last Update Posted : July 28, 2017
Information provided by (Responsible Party):
Braintree Laboratories

Brief Summary:
The objective of the study is to compare the safety and efficacy of multiple formulations of BLI1100 to a control group and placebo in treating patients with moderate-severe acne vulgaris.

Condition or disease Intervention/treatment Phase
Acne Vulgaris Drug: BLI1100-1 Drug: BLI1100-2 Drug: BLI1100-3 Drug: BLI1100-4 Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 509 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Controlled Evaluation of the Safety and Efficacy of Topical Treatments for Moderate-Severe Facial Acne Vulgaris
Study Start Date : October 2015
Actual Primary Completion Date : June 2016
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne

Arm Intervention/treatment
Experimental: BLI1100-1
Topical gel
Drug: BLI1100-1
BLI1100-1 Topical gel

Experimental: BLI1100-2
Topical gel
Drug: BLI1100-2
BLI1100-2 Topical gel

Experimental: BLI1100-3
Topical gel
Drug: BLI1100-3
BLI1100-3 Topical gel

Experimental: BLI1100-4
Topical gel
Drug: BLI1100-4
BLI1100-4 Topical gel

Placebo Comparator: Placebo
Topical gel
Drug: Placebo
Placebo - Topical gel

Primary Outcome Measures :
  1. Absolute change in total lesion count [ Time Frame: 12 weeks ]
  2. Treatment success based on Investigator Global Assessment [ Time Frame: 12 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 45 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Males or females 12 to 45 years of age, inclusive, in good general health.
  2. Clinical diagnosis of facial acne vulgaris
  3. Patients with an Investigator's Global Assessment severity score of at least 3 that meet the following lesion count criteria:

    • A minimum of 20 but not more than 50 inflammatory lesions (including the nose)
    • A minimum of 30 but not more than 100 non-inflammatory lesions on the face (including the nose)
    • No nodules are allowed on the entire face.
  4. Each patient or parent/guardian will read and sign the consent form as required by IRB regulations. Patients under the age of 18, but of sufficient age to provide assent (as determined by IRB regulations), will complete an assent form.
  5. Female patients of childbearing potential must have a negative urine pregnancy test prior to receiving study medication.
  6. Treatment with estrogens, androgens, or anti-androgenic agents for a non-contraceptive indication must be stable for 6 months prior to the first dose of study product and remain unchanged during the study.
  7. Patients who are willing and able to follow all study procedures, attend all scheduled visits, and successfully complete the study.
  8. Patients who are mentally competent in the Investigator's judgment, to provide informed consent/assent to participate in the study

Exclusion Criteria:

  1. Patients who had been treated with:

    • systemic retinoids during a 6-month period before Visit 1 or by systemic antibiotics during a 4-week period before Visit 1
    • or by a topical treatment (eg, antibiotics, benzoyl peroxide, retinoids, azelaic acid, resorcinol, salicylates, sulfacetamide sodium and derivatives, glycolic acid, dapsone) or systemic corticosteroids during a 2-week period before the first dose of study medication.
  2. History of hereditary angio-edema
  3. Pregnancy, lactation or patient, who is not practicing effective contraception.
  4. Any clinically relevant finding at their baseline physical examination or dermatological medical history such as severe systemic diseases or diseases of the facial skin.
  5. A known endocrine malfunction (hyperthyroidism, hypothyroidism, diabetes, adrenal insufficiency).
  6. Erythroderma, immunodeficiency disorders and Mycosis Fungoides
  7. History of Epilepsy or Parkinson's disease
  8. History of alcohol and/or drug abuse within 5 years of screening
  9. Facial hair (beard), excessive scarring, sunburn or other disfigurement that may obscure the accurate assessment of acne grade
  10. Any single facial skin condition assessment graded as "Severe" at Visit 1
  11. Using drugs known to be photosensitizers because of the possibility of increased phototoxicity.
  12. Refusal to cease using the following types of facial products: astringents, toners, abradants, facials, loofahs, peels containing glycolic or other acids, masks, washes or soaps containing benzoyl peroxide (BPO), hydroquinone, sulfacetamide sodium or salicylic acid, non-mild facial cleansers, or moisturizers that contain retinol, salicylic acid, or α- or β-hydroxy acids .
  13. Using medications that are reported to exacerbate acne .
  14. Have had a facial procedure (chemical or laser peel, microdermabrasion, artificial ultraviolet therapy) performed by an esthetician, beautician, physician, nurse, or other practitioner, during the 4 weeks prior to Visit 1.
  15. Unwilling to avoid excessive swimming and sun exposure to include artificial UV light exposure (tanning beds).
  16. Patients using comedogenic makeup.
  17. Have a known hypersensitivity or previous allergic reaction to any of the components .
  18. Employees of the clinical research site or organization involved in the study, or an immediate family member (partner, offspring, parents, siblings, or sibling's offspring) of an employee.
  19. Have a member of the same household in this trial.
  20. Patients who have participated in an investigational clinical, surgical, drug, or device study within the past 30 days
  21. Patients who, in the opinion of the investigator, should not be included in the study for any reason, including inability to follow study procedures
  22. Patients who withdraw consent before completion of Visit 1 procedures

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 identifier (NCT number): NCT02604680

  Hide Study Locations
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United States, Alabama
BLI Research Site 27
Birmingham, Alabama, United States, 35205
BLI Research Site 24
Mobile, Alabama, United States, 36608
United States, Arizona
BLI Research Site 51
Tucson, Arizona, United States, 85745
United States, Arkansas
BLI Research Site 40
Rogers, Arkansas, United States, 72758
United States, California
BLI Research Site 57
Chula Vista, California, United States, 91911
BLI Research Site 56
Costa Mesa, California, United States, 92626
BLI Research Site 18
Encino, California, United States, 91436
BLI Research Site 7
Fremont, California, United States, 94538
BLI Research Site 45
Upland, California, United States, 91786
United States, Colorado
BLI Research Site 41
Denver, Colorado, United States, 80220
BLI Research Site 39
Wheat Ridge, Colorado, United States, 80033
United States, Florida
BLI Research Site 19
Hialeah, Florida, United States, 33012
BLI Research Site 49
Jupiter, Florida, United States, 33458
BLI Research Site 54
Miami Lakes, Florida, United States, 33016
BLI Research Site 12
Miami, Florida, United States, 33126
BLI Research Site 20
Ormond Beach, Florida, United States, 32174
BLI Research Site 59
Port Saint Lucie, Florida, United States, 34984
BLI Research Site 15
Saint Petersburg, Florida, United States, 33709
BLI Research Site 1
Tampa, Florida, United States, 33607
BLI Research Site 29
Tampa, Florida, United States, 33609
BLI Research Site 28
Wellington, Florida, United States, 33414
BLI Research Site 43
West Palm Beach, Florida, United States, 33406
United States, Indiana
BLI Research Site 11
Plainfield, Indiana, United States, 46168
United States, Kentucky
BLI Research Site 33
Louisville, Kentucky, United States, 40202
United States, Massachusetts
BLI Research Site 34
Beverly, Massachusetts, United States, 01915
BLI Research Site 42
Quincy, Massachusetts, United States, 02169
United States, Michigan
BLI Research Site 37
Fort Gratiot, Michigan, United States, 48059
United States, Nebraska
BLI Research Site 9
Omaha, Nebraska, United States, 68114
BLI Research Site 47
Omaha, Nebraska, United States, 68144
United States, New Hampshire
BLI Research Site 5
Newington, New Hampshire, United States, 03801
United States, New York
BLI Research Site 46
Stony Brook, New York, United States, 11790
United States, North Carolina
BLI Research Site 50
High Point, North Carolina, United States, 27262
BLI Research Site 52
Wilmington, North Carolina, United States, 28401
United States, Ohio
BLI Research Site 32
Cincinnati, Ohio, United States, 45255
United States, Oklahoma
BLI Research Site 55
Norman, Oklahoma, United States, 73071
United States, Oregon
BLI Research Site 4
Gresham, Oregon, United States, 97030
United States, Pennsylvania
BLI Research Site 60
Philadelphia, Pennsylvania, United States, 19103
United States, Rhode Island
BLI Research Site 10
Johnston, Rhode Island, United States, 02919
United States, Tennessee
BLI Research Site 53
Goodlettsville, Tennessee, United States, 37072
BLI Research Site 58
Murfreesboro, Tennessee, United States, 37130
BLI Research Site 14
Nashville, Tennessee, United States, 37203
United States, Texas
BLI Research Site 30
Beaumont, Texas, United States, 77701
BLI Research Site 6
Bryan, Texas, United States, 77802
BLI Research Site 3
Houston, Texas, United States, 77056
BLI Research Site 8
New Braunfels, Texas, United States, 78130
BLI Research Site 44
Pflugerville, Texas, United States, 78660
BLI Research Site 16
San Antonio, Texas, United States, 78249
United States, Utah
BLI Research Site 21
Salt Lake City, Utah, United States, 84117
United States, Virginia
BLI Research Site 26
Norfolk, Virginia, United States, 23507
United States, Washington
BLI Research Site 25
Spokane, Washington, United States, 99202
Sponsors and Collaborators
Braintree Laboratories
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Study Director: John McGowan Braintree Laboratories, Inc.

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Responsible Party: Braintree Laboratories Identifier: NCT02604680     History of Changes
Other Study ID Numbers: BLI1100-203
First Posted: November 13, 2015    Key Record Dates
Last Update Posted: July 28, 2017
Last Verified: July 2017
Additional relevant MeSH terms:
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Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases