Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Study to Evaluate the Safety and Efficacy of CB-03-01 Cream, 1% in Subjects With Facial Acne Vulgaris (26)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02608476
Recruitment Status : Completed
First Posted : November 18, 2015
Last Update Posted : June 12, 2019
Sponsor:
Information provided by (Responsible Party):
Cassiopea SpA

Brief Summary:
The primary objective of this study is to determine the safety and efficacy of CB-03-01 cream, 1%, versus the vehicle cream applied twice daily for 12 weeks in subjects with facial acne vulgaris.

Condition or disease Intervention/treatment Phase
Acne Vulgaris Drug: CB-03-01 cream, 1% Drug: Vehicle cream Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 732 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 3, Multicenter, Randomized, Double-Blind, Vehicle-Controlled Study to Evaluate the Safety and Efficacy of Cortexolone 17α-Propionate (CB-03-01) Cream, 1% Applied Twice Daily for 12 Weeks in Subjects With Facial Acne Vulgaris
Actual Study Start Date : November 16, 2015
Actual Primary Completion Date : February 21, 2018
Actual Study Completion Date : February 21, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne

Arm Intervention/treatment
Experimental: CB-03-01 cream
CB-03-01 cream, 1% applied twice daily for 12 weeks
Drug: CB-03-01 cream, 1%
CB-03-01 (cortexolone 17α-propionate) is a steroidal antiandrogen that is being developed as a 1% cream for the topical treatment of acne vulgaris.
Other Name: cortexolone 17α-propionate

Placebo Comparator: Vehicle cream
Vehicle cream applied twice daily for 12 weeks
Drug: Vehicle cream
Vehicle cream manufactured to mimic look and feel of CB-03-01 but without the active ingredient cortexolone 17α-propionate.




Primary Outcome Measures :
  1. Success rate in Investigator's Global Assessment (IGA) [ Time Frame: Week 12 ]
    Proportion of subjects in each treatment group achieving "success" at Week 12, with "success" defined as an IGA score of "clear (score=0)" or "almost clear (score=1)" and at least a two-point reduction in IGA compared to Baseline.

  2. Change from baseline in non-inflammatory lesion counts [ Time Frame: Baseline and Week 12 ]
    Absolute change from Baseline in non-inflammatory lesion counts in each treatment group at Week 12.

  3. Change from baseline in inflammatory lesion counts [ Time Frame: Baseline and Week 12 ]
    Absolute change from Baseline in inflammatory lesion counts in each treatment group at Week 12.


Secondary Outcome Measures :
  1. Change from baseline in total lesion counts [ Time Frame: Baseline and Week 12 ]
    Absolute change from Baseline in total lesions counts in each treatment group at Week 12.

  2. Percent change from baseline in total lesion counts [ Time Frame: Baseline and Week 12 ]
    Percent change from Baseline in total lesions counts in each treatment group at Week 12.

  3. Percent change from baseline in non-inflammatory lesion counts [ Time Frame: Baseline and Week 12 ]
    Percent change from Baseline in non-inflammatory lesions count in each treatment group at Week 12.

  4. Percent change from baseline in inflammatory lesion counts [ Time Frame: Baseline and Week 12 ]
    Percent change from Baseline in inflammatory lesions count in each treatment group at Week 12.


Other Outcome Measures:
  1. Local Site Reactions [ Time Frame: Baseline, Weeks 4, 8, and 12 ]
    Local Site Reactions (LSRs) including telangiectasia, skin atrophy, striae rubrae, erythema, edema, scaling/dryness, stinging/burning, and pruritus scored by frequency and severity at every visit (Baseline, Weeks 4, 8, and 12).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   9 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subject is male or non-pregnant female, 9 years of age or older. Females must be post-menopausal, surgically sterile, or using highly effective birth control methods. Women of child-bearing potential must have a negative urine pregnancy test (UPT) at the Screening/Baseline Visit.
  2. Subject has provided written and verbal informed consent/assent. A subject under 18 years of age must provide written informed assent and be accompanied by the parent or legal guardian at the time of assent/consent signing.
  3. Subject has an Investigator's Global Assessment (IGA) score of 3 (moderate) or 4 (severe) [0 (clear) to 4 (severe) scale].
  4. Subject has facial acne vulgaris with at least 30 to a maximum of 75 inflammatory lesions (papules, pustules, and nodules) and 30 to a maximum of 100 non-inflammatory lesions (open and closed comedones).
  5. Subject and parent/guardian (if applicable) are willing to comply with study instructions and return to the clinic for required visits.
  6. Subject has used the same type and brand of make-up, other facial products (exclusive of RX/OTC acne cleansers) and hair products (e.g., shampoo, gel, hair spray, mousse, etc.) for at least one (1) month prior to the Baseline Visit and agrees to continue his/her other general skin and hair care products and regimen for the entire study.

Exclusion Criteria:

  1. Subject is pregnant, lactating, or is planning to become pregnant during the study.
  2. Subject has any skin pathology or condition that could interfere with the evaluation of the test products or requires the use of interfering topical or systemic therapy.
  3. Subject has greater than two (2) facial nodules.
  4. Subject has nodulocystic acne.
  5. Subject has any condition which, in the investigator's opinion, would make it unsafe for the subject to participate in this research study.
  6. Subject is currently enrolled in an investigational drug or device study.
  7. Subject has received an investigational drug or has been treated with an investigational device within 30 days prior to the initiation of treatment (Baseline).
  8. Subject has facial hair that could interfere with the study assessments in the opinion of the investigator.
  9. Subject and parent/guardian (if applicable) are unable to communicate or cooperate with the investigator due to language problems, poor mental development, or impaired cerebral function.
  10. Subject may be unreliable for the study including subjects who engage in excessive alcohol intake or drug abuse, or subjects who are unable to return for scheduled follow-up visits.
  11. Subject has known hypersensitivity or previous allergic reaction to any of the active or inactive components of the test articles.
  12. Subject has the need or plans to be exposed to artificial tanning devices or excessive sunlight during the trial.
  13. Subject has used any of the prohibited topical anti-acne treatments or procedures prior to the study unless appropriate washout period is documented.
  14. Subject has used used any of the prohibited systemic anti-acne medications prior to the study unless appropriate washout period is documented.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02608476


  Hide Study Locations
Locations
Layout table for location information
United States, Arizona
Clear dermatology & Aesthetic Center
Scottsdale, Arizona, United States, 85255
United States, Arkansas
Johnson Dermatology
Fort Smith, Arkansas, United States, 72916
United States, California
Center for Dermatology and Laser Surgery
Sacramento, California, United States, 95819
United States, Florida
Belleair Research Center
Pinellas Park, Florida, United States, 33781
United States, Illinois
Arlington Dermatology
Arlington Heights, Illinois, United States, 60005
United States, Kansas
Kansas City Dermatology, PA
Overland Park, Kansas, United States, 66215
United States, Maryland
Maryland Laser Skin and Vein Institute
Hunt Valley, Maryland, United States, 21030
United States, New York
Sadick Research Group, LLC
New York, New York, United States, 10075
Skin Specialty Dermatology
New York, New York, United States, 10155
United States, Rhode Island
Clinical Partners, LLC
Johnston, Rhode Island, United States, 02919
United States, Texas
Texas Dermatology and Laser Specialists
San Antonio, Texas, United States, 78218
Progressive Clinical Research, PA
San Antonio, Texas, United States, 78229
Bulgaria
Site 3521
Plovdiv, Bulgaria, 4000
Site 3523
Sofia, Bulgaria, 1000
Site 3525
Sofia, Bulgaria, 1404
3520
Sofia, Bulgaria, 1407
Site 3524
Sofia, Bulgaria, 1407
Site 3519
Sofia, Bulgaria, 1431
Site 3526
Sofia, Bulgaria, 1618
Site 3522
Varna, Bulgaria, 9010
Georgia
Site 9923
Batumi, Georgia, 6010
Site 9924
Kutaisi, Georgia, 4600
Site 9921
Tbilisi, Georgia, 0145
Site 9920
Tbilisi, Georgia, 0177
Site 9922
Tbilisi, Georgia, 0186
Site 9925
Zugdidi, Georgia, 2100
Poland
4819
Bydgoszcz, Poland, 85-863
Site 4814
Czestochowa, Poland, 15-794
Site 4822
Czestochowa, Poland, 42-217
4815
Katowice, Poland, 40-611
Site 4811
Katowice, Poland, 62-069
Site 4821
Kraków, Poland, 30-002
Site 4815
Kraków, Poland, 40-611
Site 4813
Kraków, Poland, 70-332
Site 4823
Osielsko, Poland, 86-031
Site 4816
Rzeszów, Poland, 61-113
Site 4812
Szczecin, Poland, 51-685
Site 4818
Warszawa, Poland, 02-106
Site 4820
Łódź, Poland, 91-334
Romania
Site 4033
Sector 2, Bucharest, Romania, 020125
Site 4034
Sector 2, Bucharest, Romania, 020125
Site 4031
Sector 3, Bucharest, Romania, 030303
Site 4029
Sector 6, Bucharest, Romania, 062272
Site 4028
Târgovişte, Jud. Dambovita, Romania
Site 4036
Bucarest, Romania, 010825
Site 4035
Bucharest, Romania, 011025
Site 4032
Craiova, Romania, 200642
Site 4037
Iaşi, Romania, 700381
Site 4030
Sibiu, Romania, 550245
Serbia
Site 8138
Belgrade, Serbia, 11050
Site 8137
Belgrade, Serbia, 8137
Site 8136
Novi Sad, Serbia, 21000
Sponsors and Collaborators
Cassiopea SpA
Investigators
Layout table for investigator information
Study Director: Alessandro Mazzetti, MD Cassiopea S.p.A.

Additional Information:
Layout table for additonal information
Responsible Party: Cassiopea SpA
ClinicalTrials.gov Identifier: NCT02608476     History of Changes
Other Study ID Numbers: CB-03-01/26
First Posted: November 18, 2015    Key Record Dates
Last Update Posted: June 12, 2019
Last Verified: June 2019

Keywords provided by Cassiopea SpA:
acne

Additional relevant MeSH terms:
Layout table for MeSH terms
Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases