NCT01320033

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

Completed Phase 2 Results posted Last updated 18 February 2021

What this trial tests

Phase 2 trial testing CD2475/101 40 mg in Acne Vulgaris in 662 participants. Completed in 3 January 2012.

Timeline

29 March 2011

Primary endpoint
3 January 2012

3 January 2012

Quick facts

Lead sponsor	Galderma R&D
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	662
Start date	29 March 2011
Primary completion	3 January 2012
Estimated completion	3 January 2012
Sites	31 locations across United States

Drugs / interventions tested

• CD2475/101 40 mg — full drug profile →
• Doxycycline 100 mg
• Placebo

Conditions studied

• Acne Vulgaris — all drugs for Acne Vulgaris →

Sponsor

Galderma R&D — full company profile →

Who can join

12 and older, any sex, with Acne Vulgaris. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change From Baseline in Inflammatory Lesion Counts to Week 16 (Last Observation Carried Forward [LOCF]) Primary · From Baseline up to Week 16 (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.

Group	Value	95% CI
CD2475/101 40 mg	-16.1	± 11.39
Doxycycline 100 mg	-12.9	± 14.60
Placebo	-12.6	± 16.44

Investigator Global Assessment (IGA) Success Rate at Week 16 (Last Observation Carried Forward [LOCF]) Secondary · Week 16 (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 a

Group	Value	95% CI
CD2475/101 40 mg	14.4
Doxycycline 100 mg	13.8
Placebo	7.7

Percent Change From Baseline in Inflammatory Lesion Counts to Week 16 (Last Observation Carried Forward [LOCF]) Secondary · From Baseline up to Week 16 (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.

Group	Value	95% CI
CD2475/101 40 mg	-48.6	± 31.72
Doxycycline 100 mg	-40.3	± 40.90
Placebo	-37.1	± 44.45

Percent Change From Baseline in Total Lesion Counts to Week 16 (Last Observation Carried Forward [LOCF]) Secondary · From Baseline up to Week 16 (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.

Group	Value	95% CI
CD2475/101 40 mg	-38.3	± 32.24
Doxycycline 100 mg	-27.8	± 43.94
Placebo	-27.8	± 38.05

Change From Baseline in Non-Inflammatory Lesion Counts to Week 16 (Last Observation Carried Forward [LOCF]) Secondary · From Baseline up to Week 16 (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

Group	Value	95% CI
CD2475/101 40 mg	-10.0	± 21.49
Doxycycline 100 mg	-5.2	± 21.60
Placebo	-5.8	± 18.19

Global Assessment for Inflammatory Lesions of Truncal Acne at Baseline, Week 12, and Week 16 Secondary · 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

Baseline : Lesion of Truncal Acne on Back

Group	Value	95% CI
CD2475/101 40 mg	1.6	± 1.10
Doxycycline 100 mg	1.5	± 1.09
Placebo	1.5	± 1.07

Baseline : Lesion of Truncal Acne on Chest

Group	Value	95% CI
CD2475/101 40 mg	1.2	± 1.04
Doxycycline 100 mg	1.2	± 1.00
Placebo	1.1	± 0.98

Week 12 : Lesions of Truncal Acne on Back

Group	Value	95% CI
CD2475/101 40 mg	1.2	± 1.06
Doxycycline 100 mg	1.1	± 1.05
Placebo	1.2	± 1.04

Week 12 : Lesion of Truncal Acne on Chest

Group	Value	95% CI
CD2475/101 40 mg	0.9	± 0.94
Doxycycline 100 mg	0.9	± 0.99
Placebo	0.9	± 0.95

Week 16 : Lesions of Truncal Acne on Back

Group	Value	95% CI
CD2475/101 40 mg	1.1	± 1.06
Doxycycline 100 mg	1.0	± 1.06
Placebo	1.2	± 1.03

Week 16 : Lesion of Truncal Acne on Chest

Group	Value	95% CI
CD2475/101 40 mg	0.9	± 1.01
Doxycycline 100 mg	0.8	± 0.93
Placebo	0.9	± 0.95

Number of Participants With at Least One Adverse Event (AE) Secondary · From Baseline up to Week 16

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.

Group	Value	95% CI
CD2475/101 40 mg	63
Doxycycline 100 mg	83
Placebo	89

Adverse events — posted to ClinicalTrials.gov

Time frame: From Baseline up to Week 16. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

CD2475/101 40 mg

Serious: 1/216 (0%)

Deaths: 0/216

Doxycycline 100 mg

Serious: 4/223 (2%)

Deaths: 0/223

Placebo

Serious: 2/222 (1%)

Deaths: 0/222

Serious adverse events (11 terms)

Reaction	System	CD2475/101 40 mg	Doxycycline 100 mg	Placebo
Affective disorder	Psychiatric disorders	—	—	—
Suicide attempt	Psychiatric disorders	—	—	—
Depression	Psychiatric disorders	—	—	—
Coagulopathy	Blood and lymphatic system disorders	—	—	—
Forearm fracture	Injury, poisoning and procedural complications	—	—	—
Fall	Injury, poisoning and procedural complications	—	—	—
Multiple drug overdose intentional	Injury, poisoning and procedural complications	—	—	—
Uterine leiomyoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—
Multiple sclerosis relapse	Nervous system disorders	—	—	—
Hepatic encephalopathy	Nervous system disorders	—	—	—
Urticaria	Skin and subcutaneous tissue disorders	—	—	—

Other adverse events (4 terms — click to expand)

Reaction	System	CD2475/101 40 mg	Doxycycline 100 mg	Placebo
Headache	Nervous system disorders	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—
Nasopharyngitis	Infections and infestations	—	—	—
Nausea	Gastrointestinal disorders	—	—	—

Most-reported serious reactions: Affective disorder, Suicide attempt, Depression, Coagulopathy, Forearm fracture, Fall, Multiple drug overdose intentional, Uterine leiomyoma.

Data from ClinicalTrials.gov NCT01320033 adverse events section.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.