Placebo Controlled Efficacy and Safety Study of CD2475/101 40 mg Tablets vs. Placebo and Doxycycline 100 mg Capsules Once Daily in the Treatment of Inflammatory Lesions of Acne Vulgaris

Acne Vulgaris Clinical Trial

Official title:

A Multi Center, Randomized, Double Blind, Placebo Controlled, 3 Arm, Parallel Group Study Comparing the Efficacy and Safety of CD2475/101 40 mg Tablets Versus Placebo and Doxycycline 100 mg Capsules Once Daily in the Treatment of Inflammatory Lesions in Subjects With Acne Vulgaris

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01320033
• Other study ID #: RD.06.SPR.18195
• Status: Completed
• Phase: Phase 2
• Start date: March 29, 2011
• Est. completion date: January 3, 2012

Study information

• Verified date: December 2019
• Source: Galderma R&D
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The primary objectives of the study is to show CD2475/101 40mg tablets taken once a day for 16 weeks is superior to the placebo in Change from baseline to Week 16(Last Observation Carry Forward, Intent To Treat) in inflammatory lesion counts.

Description:

Investigator's global assessment and lesion count will be performed at each study visit.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 662
• Est. completion date: January 3, 2012
• Est. primary completion date: January 3, 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

Inclusion Criteria:

• Male and female subjects 12 years of age or older

• acne vulgaris with facial involvement

• A score of 3 (Moderate) or 4 (Severe) on the Investigator's Global Assessment Scale (inflammatory)

• 25 to 75 inflammatory lesions (papules and pustules) on the face (including the nose)

Exclusion Criteria:

• More than two acne nodules/cysts on the face

• Acne conglobata, acne fulminans, secondary acne (chloracne, drug induced acne, etc.), or severe acne requiring systemic retinoid treatment

• Underlying diseases or other dermatologic conditions that require the use of interfering topical or systemic therapy such as, but not limited to, atopic dermatitis, perioral dermatitis or rosacea

• Beard or facial hair which might interfere with study assessments

• planning excessive exposure to sun or ultraviolet light during the study (i.e. natural or artificial sunlight, including tanning booths and sun lamp)

• Use of oral contraceptives solely for control of acne

• Liver function test alanine transaminase (ALT) and/or aspartate transaminase (AST) 2.5 times above upper limit of normal

• Renal function test serum creatinine at 150 umol/L (17 mg/L) or higher

• Presence of oral or genital candidiasis or history of multiple episodes of oral or genital candidiasis

• Females who intend to conceive a child within 5 months following Baseline visit

• Males who intend to conceive a child with partner during the study period

• Requiring concomitant use of methoxyflurane

Related Conditions & MeSH terms

• Acne Vulgaris

Intervention

Drug:
• CD2475/101 40 mg
Participants receive 40 mg of CD2475/101 tablets once a day for 16 weeks.
• Doxycycline 100 mg
Participants receive 100 mg of Doxycycline capsule once a day for 16 weeks
• Placebo
Participants receive matching placebo tablet, matching placebo capsule once a day for 16 weeks.

Locations

Country	Name	City	State
United States	Academic Dermatology	Albuquerque	New Mexico
United States	Arlington Center for Dermatology	Arlington	Texas
United States	Derm Research, Inc	Austin	Texas
United States	J&S Studies	College Station	Texas
United States	Colorado Medical Research Center	Denver	Colorado
United States	Palmetto Clinical Trial Services, LLC	Greenville	South Carolina
United States	Stephen Schleicher	Hazleton	Pennsylvania
United States	Dermatology Consulting Services	High Point	North Carolina
United States	Burke Pharmaceutical Research	Hot Springs	Arkansas
United States	Center for Clinical Studies	Houston	Texas
United States	Suzanne Bruce and associates P.A. The Center for skin Research	Houston	Texas
United States	Longmont Medical Research Network	Longmont	Colorado
United States	Dermatology Research Associates, Inc.	Los Angeles	California
United States	Dermatology Specialists PC	Louisville	Kentucky
United States	International Dermatology Research, Inc.	Miami	Florida
United States	Dermatology Research Associates	Nashville	Tennessee
United States	Tennessee Clinical Research Center	Nashville	Tennessee
United States	MedaPhase, Inc.	Newnan	Georgia
United States	Central Sooner Research	Norman	Oklahoma
United States	Skin Specialists, PC	Omaha	Nebraska
United States	Oregon Dermatology & Research Center	Portland	Oregon
United States	Helendale Dermatology & Medical Spa	Rochester	New York
United States	Central Dermatology, PC	Saint Louis	Missouri
United States	Dermatology Research Center	Salt Lake City	Utah
United States	Progressive Clinical Research	San Antonio	Texas
United States	Stephen Miller MD	San Antonio	Texas
United States	Haber Dermatology & cosmetic Surgery, Inc	South Euclid	Ohio
United States	Premier Clinical Research	Spokane	Washington
United States	Somerset Skin Care Center	Troy	Michigan
United States	Grekin Skin Care	Warren	Michigan
United States	PMG Research of Wilmington	Wilmington	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Galderma R&D

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Inflammatory Lesion Counts to Week 16 (Last Observation Carried Forward [LOCF])	The Inflammatory lesion count was the count of papules and pustules: papule was a small, solid elevation less than 0.5 cm in diameter, pustule was a small, circumscribed elevation of the skin that contains yellow-white exudate. Change from baseline in inflammatory lesion counts to Week 16 (LOCF) were reported.	From Baseline up to Week 16 (LOCF)
Secondary	Investigator Global Assessment (IGA) Success Rate at Week 16 (Last Observation Carried Forward [LOCF])	IGA scale consisted of 5 grades (0-4) among which 0= Clear (no evidence of papules or pustules [inflammatory lesions]), 1= Almost clear (rare non-inflamed papules (papules must be resolving and hyperpigmented, though not pink-red), 2= Mild (few inflammatory lesions [papules/pustules only; no nodulo-cystic lesions]), 3=Moderate (multiple inflammatory lesions evident: many papules/pustules; up to two nodulocystic lesions), 4= Severe (inflammatory lesions are more apparent, many papules/pustules, few nodulo-cystic lesions). Success rate was defined as percentage of participants who achieved an Investigator Global Assessment (IGA) score of 1 (almost clear) or 0 (Clear) and at least a 2-grade improvement from Baseline to Week 16 (LOCF).	Week 16 (LOCF)
Secondary	Percent Change From Baseline in Inflammatory Lesion Counts to Week 16 (Last Observation Carried Forward [LOCF])	The Inflammatory lesion count was the count of papules and pustules: papule was a small, solid elevation less than 0.5 cm in diameter, pustule was a small, circumscribed elevation of the skin that contains yellow-white exudate. Percent change from baseline in inflammatory lesion counts to Week 16 (LOCF) were reported.	From Baseline up to Week 16 (LOCF)
Secondary	Percent Change From Baseline in Total Lesion Counts to Week 16 (Last Observation Carried Forward [LOCF])	Total lesions were the sum of inflammatory lesion counts, non-inflammatory lesion counts, nodules and cysts. Percentage change from baseline in total lesion counts to Week 16 were reported.	From Baseline up to Week 16 (LOCF)
Secondary	Change From Baseline in Non-Inflammatory Lesion Counts to Week 16 (Last Observation Carried Forward [LOCF])	The non-inflammatory lesion count was the count of open and closed comedones: Open comedone was a pigmented dilated pilosebaceous orifice (blackhead). Closed comedone was a tiny white papule (whitehead). Change from baseline in non-inflammatory lesion counts to week 16 were reported	From Baseline up to Week 16 (LOCF)
Secondary	Global Assessment for Inflammatory Lesions of Truncal Acne at Baseline, Week 12, and Week 16	Global assessments for inflammatory lesions of truncal acne were done separately on back and chest. The global assessments severity scale included 5 grades (0-4): where in 0= Clear-no evidence of papules or pustules (inflammatory lesions), 1= Almost clear- rare non-inflamed papules (papules must be resolving and may be hyperpigmented, though not pink-red), 2=Mild- few inflammatory lesions (papules/pustules only; no nodulo-cystic lesions), 3=Moderate- multiple inflammatory lesions evident: many papules/pustules; may be a few nodulocystic lesions, 4=Severe- inflammatory lesions are more apparent, many papules/pustules, may be a few nodulo-cystic lesions.	Baseline, Week 12, and Week 16
Secondary	Number of Participants With at Least One Adverse Event (AE)	An AE was any untoward medical occurrence in a participant or clinical investigation participants administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. Number of participants with at least one AE were reported.	From Baseline up to Week 16