Overview

This trial is active, not recruiting.

Condition acne vulgaris
Treatments bli1100-1, bli1100-2, bli1100-3, control group, placebo
Phase phase 2
Sponsor Braintree Laboratories
Start date October 2015
End date November 2016
Trial size 509 participants
Trial identifier NCT02604680, BLI1100-203

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
Topical gel
bli1100-1
BLI1100-1 Topical gel
(Experimental)
Topical gel
bli1100-2
BLI1100-2 Topical gel
(Experimental)
Topical gel
bli1100-3
BLI1100-3 Topical gel
(Active Comparator)
Topical gel
control group
Control group - Topical gel
(Placebo Comparator)
Topical gel
placebo
Placebo - Topical gel

Primary Outcomes

Measure
Absolute change in total lesion count
time frame: 12 weeks
Treatment success based on Investigator Global Assessment
time frame: 12 weeks

Eligibility Criteria

Male or female participants from 12 years up to 45 years old.

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

Additional Information

Official title A Randomized, Controlled Evaluation of the Safety and Efficacy of Topical Treatments for Moderate-Severe Facial Acne Vulgaris
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by Braintree Laboratories.