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

Completed · Phase 2 · Has a placebo group

Conditions studied: Acne Vulgaris

In brief

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.

Key facts

Study ID: NCT02604680
Run by: Braintree Laboratories
People needed: 509
Starts: 2015-10-01
Expected to finish: 2016-06-01
Last updated by the study team: 2017-07-28

Who can join

Age: 12 and older, up to 45. Sex: any. Healthy volunteers: not accepted.

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 .
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

Where it is running

BLI Research Site 27 — Birmingham, Alabama, United States
BLI Research Site 24 — Mobile, Alabama, United States
BLI Research Site 51 — Tucson, Arizona, United States
BLI Research Site 40 — Rogers, Arkansas, United States
BLI Research Site 57 — Chula Vista, California, United States
BLI Research Site 56 — Costa Mesa, California, United States
BLI Research Site 18 — Encino, California, United States
BLI Research Site 7 — Fremont, California, United States
BLI Research Site 45 — Upland, California, United States
BLI Research Site 41 — Denver, Colorado, United States
BLI Research Site 39 — Wheat Ridge, Colorado, United States
BLI Research Site 19 — Hialeah, Florida, United States
BLI Research Site 49 — Jupiter, Florida, United States
BLI Research Site 12 — Miami, Florida, United States
BLI Research Site 54 — Miami Lakes, Florida, United States
BLI Research Site 20 — Ormond Beach, Florida, United States
BLI Research Site 59 — Port Saint Lucie, Florida, United States
BLI Research Site 15 — St. Petersburg, Florida, United States
BLI Research Site 1 — Tampa, Florida, United States
BLI Research Site 29 — Tampa, Florida, United States
BLI Research Site 28 — Wellington, Florida, United States
BLI Research Site 43 — West Palm Beach, Florida, United States
BLI Research Site 11 — Plainfield, Indiana, United States
BLI Research Site 33 — Louisville, Kentucky, United States
BLI Research Site 34 — Beverly, Massachusetts, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.