A Safety and Efficacy Evaluation of Topical Treatments for Moderate-Severe Facial Acne Vulgaris
NCT ID: NCT02604680
Last Updated: 2017-07-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
509 participants
INTERVENTIONAL
2015-10-31
2016-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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BLI1100-1
Topical gel
BLI1100-1
BLI1100-1 Topical gel
BLI1100-2
Topical gel
BLI1100-2
BLI1100-2 Topical gel
BLI1100-3
Topical gel
BLI1100-3
BLI1100-3 Topical gel
BLI1100-4
Topical gel
BLI1100-4
BLI1100-4 Topical gel
Placebo
Topical gel
Placebo
Placebo - Topical gel
Interventions
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BLI1100-1
BLI1100-1 Topical gel
BLI1100-2
BLI1100-2 Topical gel
BLI1100-3
BLI1100-3 Topical gel
BLI1100-4
BLI1100-4 Topical gel
Placebo
Placebo - Topical gel
Eligibility Criteria
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Inclusion Criteria
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
* 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
12 Years
45 Years
ALL
No
Sponsors
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Braintree Laboratories
INDUSTRY
Responsible Party
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Principal Investigators
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John McGowan
Role: STUDY_DIRECTOR
Braintree Laboratories, Inc.
Locations
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BLI Research Site 27
Birmingham, Alabama, United States
BLI Research Site 24
Mobile, Alabama, United States
BLI Research Site 51
Tucson, Arizona, United States
BLI Research Site 40
Rogers, Arkansas, United States
BLI Research Site 57
Chula Vista, California, United States
BLI Research Site 56
Costa Mesa, California, United States
BLI Research Site 18
Encino, California, United States
BLI Research Site 7
Fremont, California, United States
BLI Research Site 45
Upland, California, United States
BLI Research Site 41
Denver, Colorado, United States
BLI Research Site 39
Wheat Ridge, Colorado, United States
BLI Research Site 19
Hialeah, Florida, United States
BLI Research Site 49
Jupiter, Florida, United States
BLI Research Site 12
Miami, Florida, United States
BLI Research Site 54
Miami Lakes, Florida, United States
BLI Research Site 20
Ormond Beach, Florida, United States
BLI Research Site 59
Port Saint Lucie, Florida, United States
BLI Research Site 15
St. Petersburg, Florida, United States
BLI Research Site 1
Tampa, Florida, United States
BLI Research Site 29
Tampa, Florida, United States
BLI Research Site 28
Wellington, Florida, United States
BLI Research Site 43
West Palm Beach, Florida, United States
BLI Research Site 11
Plainfield, Indiana, United States
BLI Research Site 33
Louisville, Kentucky, United States
BLI Research Site 34
Beverly, Massachusetts, United States
BLI Research Site 42
Quincy, Massachusetts, United States
BLI Research Site 37
Fort Gratiot, Michigan, United States
BLI Research Site 9
Omaha, Nebraska, United States
BLI Research Site 47
Omaha, Nebraska, United States
BLI Research Site 5
Newington, New Hampshire, United States
BLI Research Site 46
Stony Brook, New York, United States
BLI Research Site 50
High Point, North Carolina, United States
BLI Research Site 52
Wilmington, North Carolina, United States
BLI Research Site 32
Cincinnati, Ohio, United States
BLI Research Site 55
Norman, Oklahoma, United States
BLI Research Site 4
Gresham, Oregon, United States
BLI Research Site 60
Philadelphia, Pennsylvania, United States
BLI Research Site 10
Johnston, Rhode Island, United States
BLI Research Site 53
Goodlettsville, Tennessee, United States
BLI Research Site 58
Murfreesboro, Tennessee, United States
BLI Research Site 14
Nashville, Tennessee, United States
BLI Research Site 30
Beaumont, Texas, United States
BLI Research Site 6
Bryan, Texas, United States
BLI Research Site 3
Houston, Texas, United States
BLI Research Site 8
New Braunfels, Texas, United States
BLI Research Site 44
Pflugerville, Texas, United States
BLI Research Site 16
San Antonio, Texas, United States
BLI Research Site 21
Salt Lake City, Utah, United States
BLI Research Site 26
Norfolk, Virginia, United States
BLI Research Site 25
Spokane, Washington, United States
Countries
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Other Identifiers
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BLI1100-203
Identifier Type: -
Identifier Source: org_study_id
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