A Safety and Efficacy Evaluation of Topical Treatments for Moderate-Severe Facial Acne Vulgaris
27 juli 2017 uppdaterad av: Braintree Laboratories
A Randomized, Controlled Evaluation of the Safety and Efficacy of Topical Treatments for Moderate-Severe Facial Acne Vulgaris
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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Faktisk)
509
Fas
- Fas 2
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Alabama
-
Birmingham, Alabama, Förenta staterna, 35205
- BLI Research Site 27
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Mobile, Alabama, Förenta staterna, 36608
- BLI Research Site 24
-
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Arizona
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Tucson, Arizona, Förenta staterna, 85745
- BLI Research Site 51
-
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Arkansas
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Rogers, Arkansas, Förenta staterna, 72758
- BLI Research Site 40
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California
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Chula Vista, California, Förenta staterna, 91911
- BLI Research Site 57
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Costa Mesa, California, Förenta staterna, 92626
- BLI Research Site 56
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Encino, California, Förenta staterna, 91436
- BLI Research Site 18
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Fremont, California, Förenta staterna, 94538
- BLI Research Site 7
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Upland, California, Förenta staterna, 91786
- BLI Research Site 45
-
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Colorado
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Denver, Colorado, Förenta staterna, 80220
- BLI Research Site 41
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Wheat Ridge, Colorado, Förenta staterna, 80033
- BLI Research Site 39
-
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Florida
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Hialeah, Florida, Förenta staterna, 33012
- BLI Research Site 19
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Jupiter, Florida, Förenta staterna, 33458
- BLI Research Site 49
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Miami, Florida, Förenta staterna, 33126
- BLI Research Site 12
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Miami Lakes, Florida, Förenta staterna, 33016
- BLI Research Site 54
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Ormond Beach, Florida, Förenta staterna, 32174
- BLI Research Site 20
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Port Saint Lucie, Florida, Förenta staterna, 34984
- BLI Research Site 59
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Saint Petersburg, Florida, Förenta staterna, 33709
- BLI Research Site 15
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Tampa, Florida, Förenta staterna, 33607
- BLI Research Site 1
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Tampa, Florida, Förenta staterna, 33609
- BLI Research Site 29
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Wellington, Florida, Förenta staterna, 33414
- BLI Research Site 28
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West Palm Beach, Florida, Förenta staterna, 33406
- BLI Research Site 43
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Indiana
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Plainfield, Indiana, Förenta staterna, 46168
- BLI Research Site 11
-
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Kentucky
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Louisville, Kentucky, Förenta staterna, 40202
- BLI Research Site 33
-
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Massachusetts
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Beverly, Massachusetts, Förenta staterna, 01915
- BLI Research Site 34
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Quincy, Massachusetts, Förenta staterna, 02169
- BLI Research Site 42
-
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Michigan
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Fort Gratiot, Michigan, Förenta staterna, 48059
- BLI Research Site 37
-
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Nebraska
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Omaha, Nebraska, Förenta staterna, 68114
- BLI Research Site 9
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Omaha, Nebraska, Förenta staterna, 68144
- BLI Research Site 47
-
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New Hampshire
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Newington, New Hampshire, Förenta staterna, 03801
- BLI Research Site 5
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New York
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Stony Brook, New York, Förenta staterna, 11790
- BLI Research Site 46
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North Carolina
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High Point, North Carolina, Förenta staterna, 27262
- BLI Research Site 50
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Wilmington, North Carolina, Förenta staterna, 28401
- BLI Research Site 52
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Ohio
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Cincinnati, Ohio, Förenta staterna, 45255
- BLI Research Site 32
-
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Oklahoma
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Norman, Oklahoma, Förenta staterna, 73071
- BLI Research Site 55
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Oregon
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Gresham, Oregon, Förenta staterna, 97030
- BLI Research Site 4
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Pennsylvania
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Philadelphia, Pennsylvania, Förenta staterna, 19103
- BLI Research Site 60
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Rhode Island
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Johnston, Rhode Island, Förenta staterna, 02919
- BLI Research Site 10
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Tennessee
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Goodlettsville, Tennessee, Förenta staterna, 37072
- BLI Research Site 53
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Murfreesboro, Tennessee, Förenta staterna, 37130
- BLI Research Site 58
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Nashville, Tennessee, Förenta staterna, 37203
- BLI Research Site 14
-
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Texas
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Beaumont, Texas, Förenta staterna, 77701
- BLI Research Site 30
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Bryan, Texas, Förenta staterna, 77802
- BLI Research Site 6
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Houston, Texas, Förenta staterna, 77056
- BLI Research Site 3
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New Braunfels, Texas, Förenta staterna, 78130
- BLI Research Site 8
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Pflugerville, Texas, Förenta staterna, 78660
- BLI Research Site 44
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San Antonio, Texas, Förenta staterna, 78249
- BLI Research Site 16
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Utah
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Salt Lake City, Utah, Förenta staterna, 84117
- BLI Research Site 21
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Virginia
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Norfolk, Virginia, Förenta staterna, 23507
- BLI Research Site 26
-
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Washington
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Spokane, Washington, Förenta staterna, 99202
- BLI Research Site 25
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
12 år till 45 år (Barn, Vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Fyrdubbla
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: BLI1100-1
Topical gel
|
BLI1100-1 Topical gel
|
|
Experimentell: BLI1100-2
Topical gel
|
BLI1100-2 Topical gel
|
|
Experimentell: BLI1100-3
Topical gel
|
BLI1100-3 Topical gel
|
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Experimentell: BLI1100-4
Topical gel
|
BLI1100-4 Topical gel
|
|
Placebo-jämförare: Placebo
Topical gel
|
Placebo - Topical gel
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Absolute change in total lesion count
Tidsram: 12 weeks
|
12 weeks
|
|
Treatment success based on Investigator Global Assessment
Tidsram: 12 weeks
|
12 weeks
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 oktober 2015
Primärt slutförande (Faktisk)
1 juni 2016
Avslutad studie (Faktisk)
1 juni 2016
Studieregistreringsdatum
Först inskickad
12 november 2015
Först inskickad som uppfyllde QC-kriterierna
12 november 2015
Första postat (Uppskatta)
13 november 2015
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
28 juli 2017
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
27 juli 2017
Senast verifierad
1 juli 2017
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- BLI1100-203
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .