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

• Sponsor: Braintree Laboratories (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02604680
• Collaborator: (none)
• Enrollment: 509
• Locations: 50
• Arms: 5
• Duration (Months): 8
• Patients Per Site: 10.2
• Patients Per Site Per Month: 1.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Acne Vulgaris	Drug: BLI1100-1; Drug: BLI1100-2; Drug: BLI1100-3; Drug: BLI1100-4; Drug: Placebo	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 509 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Randomized, Controlled Evaluation of the Safety and Efficacy of Topical Treatments for Moderate-Severe Facial Acne Vulgaris
• Study Start Date: Oct 1, 2015
• Actual Primary Completion Date: Jun 1, 2016
• Actual Study Completion Date: Jun 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: BLI1100-1 Topical gel	Drug: BLI1100-1; BLI1100-1 Topical gel
Experimental: BLI1100-2 Topical gel	Drug: BLI1100-2; BLI1100-2 Topical gel
Experimental: BLI1100-3 Topical gel	Drug: BLI1100-3; BLI1100-3 Topical gel
Experimental: BLI1100-4 Topical gel	Drug: BLI1100-4; BLI1100-4 Topical gel
Placebo Comparator: Placebo Topical gel	Drug: Placebo; Placebo - Topical gel

Outcome Measures

Primary Outcome Measures

1. Absolute change in total lesion count [12 weeks]

2. Treatment success based on Investigator Global Assessment [12 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 12 Years to 45 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

1. 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.

2. Female patients of childbearing potential must have a negative urine pregnancy test prior to receiving study medication.

3. 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.

4. Patients who are willing and able to follow all study procedures, attend all scheduled visits, and successfully complete the study.

5. 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.

1. History of hereditary angio-edema

2. Pregnancy, lactation or patient, who is not practicing effective contraception.

3. Any clinically relevant finding at their baseline physical examination or dermatological medical history such as severe systemic diseases or diseases of the facial skin.

4. A known endocrine malfunction (hyperthyroidism, hypothyroidism, diabetes, adrenal insufficiency).

5. Erythroderma, immunodeficiency disorders and Mycosis Fungoides

6. History of Epilepsy or Parkinson's disease

7. History of alcohol and/or drug abuse within 5 years of screening

8. Facial hair (beard), excessive scarring, sunburn or other disfigurement that may obscure the accurate assessment of acne grade

9. Any single facial skin condition assessment graded as "Severe" at Visit 1

10. Using drugs known to be photosensitizers because of the possibility of increased phototoxicity.

11. 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 .

12. Using medications that are reported to exacerbate acne .

13. 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.

14. Unwilling to avoid excessive swimming and sun exposure to include artificial UV light exposure (tanning beds).

15. Patients using comedogenic makeup.

16. Have a known hypersensitivity or previous allergic reaction to any of the components .

17. 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.

18. Have a member of the same household in this trial.

19. Patients who have participated in an investigational clinical, surgical, drug, or device study within the past 30 days

20. Patients who, in the opinion of the investigator, should not be included in the study for any reason, including inability to follow study procedures

21. Patients who withdraw consent before completion of Visit 1 procedures

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	BLI Research Site 27	Birmingham	Alabama	United States	35205
2	BLI Research Site 24	Mobile	Alabama	United States	36608
3	BLI Research Site 51	Tucson	Arizona	United States	85745
4	BLI Research Site 40	Rogers	Arkansas	United States	72758
5	BLI Research Site 57	Chula Vista	California	United States	91911
6	BLI Research Site 56	Costa Mesa	California	United States	92626
7	BLI Research Site 18	Encino	California	United States	91436
8	BLI Research Site 7	Fremont	California	United States	94538
9	BLI Research Site 45	Upland	California	United States	91786
10	BLI Research Site 41	Denver	Colorado	United States	80220
11	BLI Research Site 39	Wheat Ridge	Colorado	United States	80033
12	BLI Research Site 19	Hialeah	Florida	United States	33012
13	BLI Research Site 49	Jupiter	Florida	United States	33458
14	BLI Research Site 54	Miami Lakes	Florida	United States	33016
15	BLI Research Site 12	Miami	Florida	United States	33126
16	BLI Research Site 20	Ormond Beach	Florida	United States	32174
17	BLI Research Site 59	Port Saint Lucie	Florida	United States	34984
18	BLI Research Site 15	Saint Petersburg	Florida	United States	33709
19	BLI Research Site 1	Tampa	Florida	United States	33607
20	BLI Research Site 29	Tampa	Florida	United States	33609
21	BLI Research Site 28	Wellington	Florida	United States	33414
22	BLI Research Site 43	West Palm Beach	Florida	United States	33406
23	BLI Research Site 11	Plainfield	Indiana	United States	46168
24	BLI Research Site 33	Louisville	Kentucky	United States	40202
25	BLI Research Site 34	Beverly	Massachusetts	United States	01915
26	BLI Research Site 42	Quincy	Massachusetts	United States	02169
27	BLI Research Site 37	Fort Gratiot	Michigan	United States	48059
28	BLI Research Site 9	Omaha	Nebraska	United States	68114
29	BLI Research Site 47	Omaha	Nebraska	United States	68144
30	BLI Research Site 5	Newington	New Hampshire	United States	03801
31	BLI Research Site 46	Stony Brook	New York	United States	11790
32	BLI Research Site 50	High Point	North Carolina	United States	27262
33	BLI Research Site 52	Wilmington	North Carolina	United States	28401
34	BLI Research Site 32	Cincinnati	Ohio	United States	45255
35	BLI Research Site 55	Norman	Oklahoma	United States	73071
36	BLI Research Site 4	Gresham	Oregon	United States	97030
37	BLI Research Site 60	Philadelphia	Pennsylvania	United States	19103
38	BLI Research Site 10	Johnston	Rhode Island	United States	02919
39	BLI Research Site 53	Goodlettsville	Tennessee	United States	37072
40	BLI Research Site 58	Murfreesboro	Tennessee	United States	37130
41	BLI Research Site 14	Nashville	Tennessee	United States	37203
42	BLI Research Site 30	Beaumont	Texas	United States	77701
43	BLI Research Site 6	Bryan	Texas	United States	77802
44	BLI Research Site 3	Houston	Texas	United States	77056
45	BLI Research Site 8	New Braunfels	Texas	United States	78130
46	BLI Research Site 44	Pflugerville	Texas	United States	78660
47	BLI Research Site 16	San Antonio	Texas	United States	78249
48	BLI Research Site 21	Salt Lake City	Utah	United States	84117
49	BLI Research Site 26	Norfolk	Virginia	United States	23507
50	BLI Research Site 25	Spokane	Washington	United States	99202

Sponsors and Collaborators

• Braintree Laboratories

Investigators

• Study Director: John McGowan, Braintree Laboratories, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Braintree Laboratories
• ClinicalTrials.gov Identifier: NCT02604680
• Other Study ID Numbers: BLI1100-203
• First Posted: Nov 13, 2015
• Last Update Posted: Jul 28, 2017
• Last Verified: Jul 1, 2017

• Additional relevant MeSH terms: Acne Vulgaris

Study Results

No Results Posted as of Jul 28, 2017