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

27. juli 2017 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

509

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

12 år til 45 år (Barn, Voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: BLI1100-1
Topical gel
Medicin: BLI1100-1
BLI1100-1 Topical gel
Eksperimentel: BLI1100-2
Topical gel
Medicin: BLI1100-2
BLI1100-2 Topical gel
Eksperimentel: BLI1100-3
Topical gel
Medicin: BLI1100-3
BLI1100-3 Topical gel
Eksperimentel: BLI1100-4
Topical gel
Medicin: BLI1100-4
BLI1100-4 Topical gel
Placebo komparator: Placebo
Topical gel
Medicin: Placebo
Placebo - Topical gel

Hvad måler undersøgelsen?

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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Braintree Laboratories

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. oktober 2015

Primær færdiggørelse (Faktiske)

1. juni 2016

Studieafslutning (Faktiske)

1. juni 2016

Datoer for studieregistrering

Først indsendt

12. november 2015

Først indsendt, der opfyldte QC-kriterier

12. november 2015

Først opslået (Skøn)

13. november 2015

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

28. juli 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

27. juli 2017

Sidst verificeret

1. juli 2017

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • BLI1100-203

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Acne Vulgaris

Kliniske forsøg med BLI1100-1

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Cote d'Ivoire

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner