A Safety and Efficacy Evaluation of Topical Treatments for Moderate-Severe Facial Acne Vulgaris

NCT02604680 | Completed Phase 2

• 1 other identifier: BLI1100-203
• Study Type: interventional
• Target: 509
• Locations: 1 country
• Sites: 50

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.

Conditions

Acne Vulgaris

Outcome Measures

Primary Outcomes (2)

• Absolute change in total lesion count

  12 weeks

• Treatment success based on Investigator Global Assessment

  12 weeks

Study Arms (5)

BLI1100-1

EXPERIMENTAL

Topical gel

Drug: BLI1100-1

BLI1100-2

EXPERIMENTAL

Topical gel

Drug: BLI1100-2

BLI1100-3

EXPERIMENTAL

Topical gel

Drug: BLI1100-3

BLI1100-4

EXPERIMENTAL

Topical gel

Drug: BLI1100-4

Placebo

PLACEBO COMPARATOR

Topical gel

Drug: Placebo

Interventions

BLI1100-1 DRUG

BLI1100-1 Topical gel

BLI1100-1

BLI1100-2 DRUG

BLI1100-2 Topical gel

BLI1100-2

BLI1100-3 DRUG

BLI1100-3 Topical gel

BLI1100-3

BLI1100-4 DRUG

BLI1100-4 Topical gel

BLI1100-4

Placebo DRUG

Placebo - Topical gel

Placebo

Eligibility Criteria

• Age: 12 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Males or females 12 to 45 years of age, inclusive, in good general health.
• Clinical diagnosis of facial acne vulgaris
• 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.
• 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.
• Female patients of childbearing potential must have a negative urine pregnancy test prior to receiving study medication.
• 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.
• Patients who are willing and able to follow all study procedures, attend all scheduled visits, and successfully complete the study.
• Patients who are mentally competent in the Investigator's judgment, to provide informed consent/assent to participate in the study

You may not qualify if:

• 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.
• History of hereditary angio-edema
• Pregnancy, lactation or patient, who is not practicing effective contraception.
• Any clinically relevant finding at their baseline physical examination or dermatological medical history such as severe systemic diseases or diseases of the facial skin.
• A known endocrine malfunction (hyperthyroidism, hypothyroidism, diabetes, adrenal insufficiency).
• Erythroderma, immunodeficiency disorders and Mycosis Fungoides
• History of Epilepsy or Parkinson's disease
• History of alcohol and/or drug abuse within 5 years of screening
• Facial hair (beard), excessive scarring, sunburn or other disfigurement that may obscure the accurate assessment of acne grade
• Any single facial skin condition assessment graded as "Severe" at Visit 1
• Using drugs known to be photosensitizers because of the possibility of increased phototoxicity.
• 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 .
• Using medications that are reported to exacerbate acne .

Sponsors & Collaborators

• Braintree Laboratories: lead

Study Sites (50)

BLI Research Site 27

Birmingham, Alabama, 35205, United States

Location

BLI Research Site 24

Mobile, Alabama, 36608, United States

Location

BLI Research Site 51

Tucson, Arizona, 85745, United States

Location

BLI Research Site 40

Rogers, Arkansas, 72758, United States

Location

BLI Research Site 57

Chula Vista, California, 91911, United States

Location

BLI Research Site 56

Costa Mesa, California, 92626, United States

Location

BLI Research Site 18

Encino, California, 91436, United States

Location

BLI Research Site 7

Fremont, California, 94538, United States

Location

BLI Research Site 45

Upland, California, 91786, United States

Location

BLI Research Site 41

Denver, Colorado, 80220, United States

Location

BLI Research Site 39

Wheat Ridge, Colorado, 80033, United States

Location

BLI Research Site 19

Hialeah, Florida, 33012, United States

Location

BLI Research Site 49

Jupiter, Florida, 33458, United States

Location

BLI Research Site 12

Miami, Florida, 33126, United States

Location

BLI Research Site 54

Miami Lakes, Florida, 33016, United States

Location

BLI Research Site 20

Ormond Beach, Florida, 32174, United States

Location

BLI Research Site 59

Port Saint Lucie, Florida, 34984, United States

Location

BLI Research Site 15

St. Petersburg, Florida, 33709, United States

Location

BLI Research Site 1

Tampa, Florida, 33607, United States

Location

BLI Research Site 29

Tampa, Florida, 33609, United States

Location

BLI Research Site 28

Wellington, Florida, 33414, United States

Location

BLI Research Site 43

West Palm Beach, Florida, 33406, United States

Location

BLI Research Site 11

Plainfield, Indiana, 46168, United States

Location

BLI Research Site 33

Louisville, Kentucky, 40202, United States

Location

BLI Research Site 34

Beverly, Massachusetts, 01915, United States

Location

BLI Research Site 42

Quincy, Massachusetts, 02169, United States

Location

BLI Research Site 37

Fort Gratiot, Michigan, 48059, United States

Location

BLI Research Site 9

Omaha, Nebraska, 68114, United States

Location

BLI Research Site 47

Omaha, Nebraska, 68144, United States

Location

BLI Research Site 5

Newington, New Hampshire, 03801, United States

Location

BLI Research Site 46

Stony Brook, New York, 11790, United States

Location

BLI Research Site 50

High Point, North Carolina, 27262, United States

Location

BLI Research Site 52

Wilmington, North Carolina, 28401, United States

Location

BLI Research Site 32

Cincinnati, Ohio, 45255, United States

Location

BLI Research Site 55

Norman, Oklahoma, 73071, United States

Location

BLI Research Site 4

Gresham, Oregon, 97030, United States

Location

BLI Research Site 60

Philadelphia, Pennsylvania, 19103, United States

Location

BLI Research Site 10

Johnston, Rhode Island, 02919, United States

Location

BLI Research Site 53

Goodlettsville, Tennessee, 37072, United States

Location

BLI Research Site 58

Murfreesboro, Tennessee, 37130, United States

Location

BLI Research Site 14

Nashville, Tennessee, 37203, United States

Location

BLI Research Site 30

Beaumont, Texas, 77701, United States

Location

BLI Research Site 6

Bryan, Texas, 77802, United States

Location

BLI Research Site 3

Houston, Texas, 77056, United States

Location

BLI Research Site 8

New Braunfels, Texas, 78130, United States

Location

BLI Research Site 44

Pflugerville, Texas, 78660, United States

Location

BLI Research Site 16

San Antonio, Texas, 78249, United States

Location

BLI Research Site 21

Salt Lake City, Utah, 84117, United States

Location

BLI Research Site 26

Norfolk, Virginia, 23507, United States

Location

BLI Research Site 25

Spokane, Washington, 99202, United States

Location

MeSH Terms

Conditions

Acne Vulgaris

Condition Hierarchy (Ancestors)

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

Study Officials

• John McGowan

  Braintree Laboratories, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 12, 2015
• First Posted: November 13, 2015
• Study Start: October 1, 2015
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: July 28, 2017

Record last verified: 2017-07

Locations

US (50)