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

Study Overview
=================
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.

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

Conditions
-----------------
Acne Vulgaris

Intervention / Treatment
-----------------
* Drug: BLI1100-1
* Drug: BLI1100-2
* Drug: BLI1100-3
* Drug: BLI1100-4
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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 Exclusion Criteria: 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 . 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. Unwilling to avoid excessive swimming and sun exposure to include artificial UV light exposure (tanning beds). Patients using comedogenic makeup. Have a known hypersensitivity or previous allergic reaction to any of the components . 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. Have a member of the same household in this trial. Patients who have participated in an investigational clinical, surgical, drug, or device study within the past 30 days Patients who, in the opinion of the investigator, should not be included in the study for any reason, including inability to follow study procedures Patients who withdraw consent before completion of Visit 1 procedures

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BLI1100-1<br>Topical gel | Drug: BLI1100-1<br>* BLI1100-1 Topical gel<br>|
| Experimental: BLI1100-2<br>Topical gel | Drug: BLI1100-2<br>* BLI1100-2 Topical gel<br>|
| Experimental: BLI1100-3<br>Topical gel | Drug: BLI1100-3<br>* BLI1100-3 Topical gel<br>|
| Experimental: BLI1100-4<br>Topical gel | Drug: BLI1100-4<br>* BLI1100-4 Topical gel<br>|
| Placebo Comparator: Placebo<br>Topical gel | Drug: Placebo<br>* Placebo - Topical gel<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

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