Clinical trial NCT02604680: A Safety and Efficacy Evaluation of Topical Treatments for Moderate-Severe Facial Acne Vulgaris
Official title: A Randomized, Controlled Evaluation of the Safety and Efficacy of Topical Treatments for Moderate-Severe Facial Acne Vulgaris
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Acne Vulgaris
Lead sponsor: Braintree Laboratories
Sponsor class: INDUSTRY
First posted: 2015-11-13
Enrollment: 509
Sex: ALL
Minimum age (years): 12
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Absolute change in total lesion count
timeFrame: 12 weeks
measure: Treatment success based on Investigator Global Assessment
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: BLI Research Site 27
state: Alabama
city: Mobile
country: United States
facility: BLI Research Site 24
state: Alabama
city: Tucson
country: United States
facility: BLI Research Site 51
state: Arizona
city: Rogers
country: United States
facility: BLI Research Site 40
state: Arkansas
city: Chula Vista
country: United States
facility: BLI Research Site 57
state: California
city: Costa Mesa
country: United States
facility: BLI Research Site 56
state: California
city: Encino
country: United States
facility: BLI Research Site 18
state: California
city: Fremont
country: United States
facility: BLI Research Site 7
state: California
city: Upland
country: United States
facility: BLI Research Site 45
state: California
city: Denver
country: United States
facility: BLI Research Site 41
state: Colorado
city: Wheat Ridge
country: United States
facility: BLI Research Site 39
state: Colorado
city: Hialeah
country: United States
facility: BLI Research Site 19
state: Florida
city: Jupiter
country: United States
facility: BLI Research Site 49
state: Florida
city: Miami Lakes
country: United States
facility: BLI Research Site 54
state: Florida
city: Miami
country: United States
facility: BLI Research Site 12
state: Florida
city: Ormond Beach
country: United States
facility: BLI Research Site 20
state: Florida
city: Port Saint Lucie
country: United States
facility: BLI Research Site 59
state: Florida
city: Saint Petersburg
country: United States
facility: BLI Research Site 15
state: Florida
city: Tampa
country: United States
facility: BLI Research Site 1
state: Florida
city: Tampa
country: United States
facility: BLI Research Site 29
state: Florida
city: Wellington
country: United States
facility: BLI Research Site 28
state: Florida
city: West Palm Beach
country: United States
facility: BLI Research Site 43
state: Florida
city: Plainfield
country: United States
facility: BLI Research Site 11
state: Indiana
city: Louisville
country: United States
facility: BLI Research Site 33
state: Kentucky
city: Beverly
country: United States
facility: BLI Research Site 34
state: Massachusetts
city: Quincy
country: United States
facility: BLI Research Site 42
state: Massachusetts
city: Fort Gratiot
country: United States
facility: BLI Research Site 37
state: Michigan
city: Omaha
country: United States
facility: BLI Research Site 9
state: Nebraska
city: Omaha
country: United States
facility: BLI Research Site 47
state: Nebraska
city: Newington
country: United States
facility: BLI Research Site 5
state: New Hampshire
city: Stony Brook
country: United States
facility: BLI Research Site 46
state: New York
city: High Point
country: United States
facility: BLI Research Site 50
state: North Carolina
city: Wilmington
country: United States
facility: BLI Research Site 52
state: North Carolina
city: Cincinnati
country: United States
facility: BLI Research Site 32
state: Ohio
city: Norman
country: United States
facility: BLI Research Site 55
state: Oklahoma
city: Gresham
country: United States
facility: BLI Research Site 4
state: Oregon
city: Philadelphia
country: United States
facility: BLI Research Site 60
state: Pennsylvania
city: Johnston
country: United States
facility: BLI Research Site 10
state: Rhode Island
city: Goodlettsville
country: United States
facility: BLI Research Site 53
state: Tennessee
city: Murfreesboro
country: United States
facility: BLI Research Site 58
state: Tennessee
city: Nashville
country: United States
facility: BLI Research Site 14
state: Tennessee
city: Beaumont
country: United States
facility: BLI Research Site 30
state: Texas
city: Bryan
country: United States
facility: BLI Research Site 6
state: Texas
city: Houston
country: United States
facility: BLI Research Site 3
state: Texas
city: New Braunfels
country: United States
facility: BLI Research Site 8
state: Texas
city: Pflugerville
country: United States
facility: BLI Research Site 44
state: Texas
city: San Antonio
country: United States
facility: BLI Research Site 16
state: Texas
city: Salt Lake City
country: United States
facility: BLI Research Site 21
state: Utah
city: Norfolk
country: United States
facility: BLI Research Site 26
state: Virginia
city: Spokane
country: United States
facility: BLI Research Site 25
state: Washington
Study officials:
affiliation: Braintree Laboratories, Inc.
name: John McGowan
role: STUDY_DIRECTOR
References: