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

27. juli 2017 oppdatert 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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

509

Fase

  • Fase 2

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

12 år til 45 år (Barn, Voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Firemannsrom

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: BLI1100-1
Topical gel
Legemiddel: BLI1100-1
BLI1100-1 Topical gel
Eksperimentell: BLI1100-2
Topical gel
Legemiddel: BLI1100-2
BLI1100-2 Topical gel
Eksperimentell: BLI1100-3
Topical gel
Legemiddel: BLI1100-3
BLI1100-3 Topical gel
Eksperimentell: BLI1100-4
Topical gel
Legemiddel: BLI1100-4
BLI1100-4 Topical gel
Placebo komparator: Placebo
Topical gel
Legemiddel: Placebo
Placebo - Topical gel

Hva måler studien?

Primære resultatmål

Resultatmål
Tidsramme
Absolute change in total lesion count
Tidsramme: 12 weeks
12 weeks
Treatment success based on Investigator Global Assessment
Tidsramme: 12 weeks
12 weeks

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Braintree Laboratories

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. oktober 2015

Primær fullføring (Faktiske)

1. juni 2016

Studiet fullført (Faktiske)

1. juni 2016

Datoer for studieregistrering

Først innsendt

12. november 2015

Først innsendt som oppfylte QC-kriteriene

12. november 2015

Først lagt ut (Anslag)

13. november 2015

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

28. juli 2017

Siste oppdatering sendt inn som oppfylte QC-kriteriene

27. juli 2017

Sist bekreftet

1. juli 2017

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • BLI1100-203

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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