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

A Randomized, Controlled Evaluation of the Safety and Efficacy of Topical Treatments for Moderate-Severe Facial Acne Vulgaris

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.

Study Overview

• Status: Completed
• Conditions: Acne Vulgaris
• Intervention / Treatment: Drug: BLI1100-1; Drug: BLI1100-2; Drug: BLI1100-3; Drug: BLI1100-4; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 509
• Phase: Phase 2

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 45 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

5

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Absolute change in total lesion count	12 weeks
Treatment success based on Investigator Global Assessment	12 weeks

Collaborators and Investigators

• Sponsor: Braintree Laboratories

Study record dates

Study Major Dates

• Study Start: October 1, 2015
• Primary Completion (Actual): June 1, 2016
• Study Completion (Actual): June 1, 2016

Study Registration Dates

• First Submitted: November 12, 2015
• First Submitted That Met QC Criteria: November 12, 2015
• First Posted (Estimate): November 13, 2015

Study Record Updates

• Last Update Posted (Actual): July 28, 2017
• Last Update Submitted That Met QC Criteria: July 27, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Acneiform Eruptions; Sebaceous Gland Diseases; Acne Vulgaris
• Other Study ID Numbers: BLI1100-203