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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.
 
ClinicalTrials.gov Identifier: NCT02604680
Recruitment Status : Completed
First Posted : November 13, 2015
Last Update Posted : July 28, 2017
Sponsor:
Information provided by (Responsible Party):
Braintree Laboratories

Tracking Information
First Submitted Date  ICMJE November 12, 2015
First Posted Date  ICMJE November 13, 2015
Last Update Posted Date July 28, 2017
Study Start Date  ICMJE October 2015
Actual Primary Completion Date June 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 12, 2015)
  • Absolute change in total lesion count [ Time Frame: 12 weeks ]
  • Treatment success based on Investigator Global Assessment [ Time Frame: 12 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02604680 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Safety and Efficacy Evaluation of Topical Treatments for Moderate-Severe Facial Acne Vulgaris
Official Title  ICMJE A Randomized, Controlled Evaluation of the Safety and Efficacy of Topical Treatments for Moderate-Severe Facial Acne Vulgaris
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Acne Vulgaris
Intervention  ICMJE
  • Drug: BLI1100-1
    BLI1100-1 Topical gel
  • Drug: BLI1100-2
    BLI1100-2 Topical gel
  • Drug: BLI1100-3
    BLI1100-3 Topical gel
  • Drug: BLI1100-4
    BLI1100-4 Topical gel
  • Drug: Placebo
    Placebo - Topical gel
Study Arms  ICMJE
  • Experimental: BLI1100-1
    Topical gel
    Intervention: Drug: BLI1100-1
  • Experimental: BLI1100-2
    Topical gel
    Intervention: Drug: BLI1100-2
  • Experimental: BLI1100-3
    Topical gel
    Intervention: Drug: BLI1100-3
  • Experimental: BLI1100-4
    Topical gel
    Intervention: Drug: BLI1100-4
  • Placebo Comparator: Placebo
    Topical gel
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 18, 2016)
509
Original Estimated Enrollment  ICMJE
 (submitted: November 12, 2015)
500
Actual Study Completion Date  ICMJE June 2016
Actual Primary Completion Date June 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years to 45 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02604680
Other Study ID Numbers  ICMJE BLI1100-203
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Braintree Laboratories
Study Sponsor  ICMJE Braintree Laboratories
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: John McGowan Braintree Laboratories, Inc.
PRS Account Braintree Laboratories
Verification Date July 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP