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

Acne Vulgaris Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02604680
• Other study ID #: BLI1100-203
• Status: Completed
• Phase: Phase 2
• First received: November 12, 2015
• Last updated: July 27, 2017
• Start date: October 2015
• Est. completion date: June 2016

Study information

• Verified date: July 2017
• Source: Braintree Laboratories
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 509
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 45 Years

Eligibility

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 a- or ß-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

Related Conditions & MeSH terms

• Acne Vulgaris

Intervention

Drug:
• BLI1100-1
BLI1100-1 Topical gel
• BLI1100-2
BLI1100-2 Topical gel
• BLI1100-3
BLI1100-3 Topical gel
• BLI1100-4
BLI1100-4 Topical gel
• Placebo
Placebo - Topical gel

Locations

Country	Name	City	State
United States	BLI Research Site 30	Beaumont	Texas
United States	BLI Research Site 34	Beverly	Massachusetts
United States	BLI Research Site 27	Birmingham	Alabama
United States	BLI Research Site 6	Bryan	Texas
United States	BLI Research Site 57	Chula Vista	California
United States	BLI Research Site 32	Cincinnati	Ohio
United States	BLI Research Site 56	Costa Mesa	California
United States	BLI Research Site 41	Denver	Colorado
United States	BLI Research Site 18	Encino	California
United States	BLI Research Site 37	Fort Gratiot	Michigan
United States	BLI Research Site 7	Fremont	California
United States	BLI Research Site 53	Goodlettsville	Tennessee
United States	BLI Research Site 4	Gresham	Oregon
United States	BLI Research Site 19	Hialeah	Florida
United States	BLI Research Site 50	High Point	North Carolina
United States	BLI Research Site 3	Houston	Texas
United States	BLI Research Site 10	Johnston	Rhode Island
United States	BLI Research Site 49	Jupiter	Florida
United States	BLI Research Site 33	Louisville	Kentucky
United States	BLI Research Site 12	Miami	Florida
United States	BLI Research Site 54	Miami Lakes	Florida
United States	BLI Research Site 24	Mobile	Alabama
United States	BLI Research Site 58	Murfreesboro	Tennessee
United States	BLI Research Site 14	Nashville	Tennessee
United States	BLI Research Site 8	New Braunfels	Texas
United States	BLI Research Site 5	Newington	New Hampshire
United States	BLI Research Site 26	Norfolk	Virginia
United States	BLI Research Site 55	Norman	Oklahoma
United States	BLI Research Site 47	Omaha	Nebraska
United States	BLI Research Site 9	Omaha	Nebraska
United States	BLI Research Site 20	Ormond Beach	Florida
United States	BLI Research Site 44	Pflugerville	Texas
United States	BLI Research Site 60	Philadelphia	Pennsylvania
United States	BLI Research Site 11	Plainfield	Indiana
United States	BLI Research Site 59	Port Saint Lucie	Florida
United States	BLI Research Site 42	Quincy	Massachusetts
United States	BLI Research Site 40	Rogers	Arkansas
United States	BLI Research Site 15	Saint Petersburg	Florida
United States	BLI Research Site 21	Salt Lake City	Utah
United States	BLI Research Site 16	San Antonio	Texas
United States	BLI Research Site 25	Spokane	Washington
United States	BLI Research Site 46	Stony Brook	New York
United States	BLI Research Site 1	Tampa	Florida
United States	BLI Research Site 29	Tampa	Florida
United States	BLI Research Site 51	Tucson	Arizona
United States	BLI Research Site 45	Upland	California
United States	BLI Research Site 28	Wellington	Florida
United States	BLI Research Site 43	West Palm Beach	Florida
United States	BLI Research Site 39	Wheat Ridge	Colorado
United States	BLI Research Site 52	Wilmington	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Braintree Laboratories

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Absolute change in total lesion count		12 weeks
Primary	Treatment success based on Investigator Global Assessment		12 weeks