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A Study to Evaluate the Safety and Efficacy of CB-03-01 Cream, 1% in Subjects With Facial Acne Vulgaris (25)

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ClinicalTrials.gov Identifier: NCT02608450
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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 708 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 : January 21, 2016
Actual Primary Completion Date : April 11, 2018
Actual Study Completion Date : April 11, 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).



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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): NCT02608450


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Locations
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United States, Arkansas
Gary M. Petrus, MD PA
Little Rock, Arkansas, United States, 72205
United States, California
Center For Dermatology Clinical Research, Inc.
Fremont, California, United States, 94538
Vitiligo & Pigmentation Institute of Southern California
Los Angeles, California, United States, 90036
San Diego Sports Medicine and Family Health Center
San Diego, California, United States, 92120
Rady Childrens Hospital, Pediatric and Adolescent Dermatology
San Diego, California, United States, 92123
Southern California Dermatology
Santa Ana, California, United States, 92701
Clinical Science Institute
Santa Monica, California, United States, 90404
Memorial Research Medical Clinic dba / Orange County Research Center
Tustin, California, United States, 92780
United States, Colorado
Horizons Clinical Research Center, LLC
Denver, Colorado, United States, 80220
United States, Florida
Site 0190
Boca Raton, Florida, United States, 33434
Study Protocol, Inc.
Boynton Beach, Florida, United States, 33437
Site 0196
Miami, Florida, United States, 33125
Site 0197
Miami, Florida, United States, 33126
Site 0198
Miami, Florida, United States, 33135
Site 0199
Miami, Florida, United States, 33145
Site 0191
Miami, Florida, United States, 33172
Site 0192
Miami, Florida, United States, 33172
Site 0195
Miami, Florida, United States, 33176
Tory Sullivan, M.D., P.A.
North Miami Beach, Florida, United States, 33162
Meridien Research
Saint Petersburg, Florida, United States, 33709
MOORE Clinical Research, Inc.
Tampa, Florida, United States, 33609
United States, Georgia
MedaPhase, Inc.
Newnan, Georgia, United States, 30263
United States, Indiana
Site 0152
Carmel, Indiana, United States, 46032
The Indiana Clinical Trials Center
Plainfield, Indiana, United States, 46168
United States, Michigan
Henry Ford Health System
Detroit, Michigan, United States, 48202
United States, Missouri
MediSearch Clinical Trials
Saint Joseph, Missouri, United States, 64506
United States, New York
The Center for Dermatology, Cosmetic & Laser Surgery
Mount Kisco, New York, United States, 10549
DermResearch Center of New York, Inc.
Stony Brook, New York, United States, 11790
United States, North Carolina
Wake Research Associates
Raleigh, North Carolina, United States, 27612
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157
United States, Oregon
Oregon Dermatology and Research Center
Portland, Oregon, United States, 97210
United States, Pennsylvania
The Pennsylvania State University and the Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
United States, Rhode Island
Omega Medical Research
Warwick, Rhode Island, United States, 02886
United States, South Carolina
Greenville Dermatology, LLC
Greenville, South Carolina, United States, 29607
United States, Tennessee
International Clinical Research - Tennessee LLC
Murfreesboro, Tennessee, United States, 37130
Tennessee Clinical Research Center
Nashville, Tennessee, United States, 37215
United States, Texas
Westlake Dermatology Clinical Research Center
Austin, Texas, United States, 78746
Bellaire Dermatology Associates
Bellaire, Texas, United States, 77401
J&S Studies, Inc.
College Station, Texas, United States, 77845
The University of Texas Health Science Center at Houston
Houston, Texas, United States, 77030
Austin Institute for Clinical Research, Inc.
Pflugerville, Texas, United States, 78660
United States, Virginia
Clinical Research Associates of Tidewater, Inc.
Norfolk, Virginia, United States, 23507
United States, Washington
Dermatology Associates
Seattle, Washington, United States, 98101
Premier Clinical Research
Spokane, Washington, United States, 99202
Georgia
Site 9911
Tbilisi, Georgia, 0159
Site 9913
Tbilisi, Georgia, 0179
Site 9912
Tbilisi, Georgia, 0194
Ukraine
Site 3802
Dnipro, Ukraine, 49000
Site 3804
Kharkiv, Ukraine, 31038
3808
Kharkiv, Ukraine, 61002
Site 3801
Kyiv, Ukraine, 01601
3807
Lviv, Ukraine, 79014
Site 3803
Ternopil', Ukraine, 46006
Site 3809
Zaporizhzhya, Ukraine, 69063
Sponsors and Collaborators
Cassiopea SpA
Investigators
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Study Director: Enrico Fragasso Cassiopea S.p.A.

Additional Information:
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Responsible Party: Cassiopea SpA
ClinicalTrials.gov Identifier: NCT02608450     History of Changes
Other Study ID Numbers: CB-03-01/25
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:
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Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases