Trial Outcomes & Findings for Comparing OTC Acne Treatment to Prescription Regimen (NCT NCT01237821)
NCT ID: NCT01237821
Last Updated: 2019-07-16
Results Overview
Participants were assessed for Erythema on a 4-point ordinal scale where 0= none; 1= mild; 2= moderate; and 3= severe. Assessments were made at baseline and weeks, 2, 4, 8, and 12, with the regression phase assessment at week 16.
COMPLETED
NA
66 participants
16 weeks
2019-07-16
Participant Flow
Participant milestones
| Measure |
BenzaClin
Evaluate and compare tolerance and efficacy of two anti-acne creams, Effaclar and Benzaclin over a twelve week period.
BenzaClin: Topical, 1% Clindamycin/5% Benzoyl Peroxide, BID, 12 weeks
|
Effaclar
Evaluate and compare tolerance and efficacy of two anti-acne creams, Effaclar and Benzaclin over a twelve week period.
Effaclar: Topical, (Benzoyl peroxide 5.5%) Bid, 12 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
32
|
34
|
|
Overall Study
COMPLETED
|
26
|
34
|
|
Overall Study
NOT COMPLETED
|
6
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Comparing OTC Acne Treatment to Prescription Regimen
Baseline characteristics by cohort
| Measure |
BenzaClin
n=26 Participants
Evaluate and compare tolerance and efficacy of two anti-acne creams, Effaclar and Benzaclin over a twelve week period.
BenzaClin: Topical, 1% Clindamycin/5% Benzoyl Peroxide, BID, 12 weeks
|
Effaclar
n=34 Participants
Evaluate and compare tolerance and efficacy of two anti-acne creams, Effaclar and Benzaclin over a twelve week period.
Effaclar: Topical, (Benzoyl peroxide 5.5%) Bid, 12 weeks
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
26 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
29.53 years
STANDARD_DEVIATION 9.81 • n=5 Participants
|
32.41 years
STANDARD_DEVIATION 9.30 • n=7 Participants
|
30.92 years
STANDARD_DEVIATION 9.60 • n=5 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
26 participants
n=5 Participants
|
34 participants
n=7 Participants
|
66 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 16 weeksPopulation: Male and female 18-50 years old, mild to moderate acne vulgaris with \>15 inflammatory lesions (papules/pustules) and \>20 non-inflammatory lesions (black heads/white heads) on the face.
Participants were assessed for Erythema on a 4-point ordinal scale where 0= none; 1= mild; 2= moderate; and 3= severe. Assessments were made at baseline and weeks, 2, 4, 8, and 12, with the regression phase assessment at week 16.
Outcome measures
| Measure |
Effaclar
n=26 Participants
Effaclar: Topical, (Benzoyl peroxide 5.5%) Bid, 12 weeks
|
Benzaclin
n=34 Participants
BenzaClin: Topical, 1% Clindamycin/5% Benzoyl Peroxide, BID, 12 weeks
|
|---|---|---|
|
Treatment Tolerability Assessment: Erythema
Baseline
|
0.3 score on a scale
Interval 0.0 to 3.0
|
0.4 score on a scale
Interval 0.0 to 3.0
|
|
Treatment Tolerability Assessment: Erythema
Week 2
|
0.6 score on a scale
Interval 0.0 to 3.0
|
0.4 score on a scale
Interval 0.0 to 3.0
|
|
Treatment Tolerability Assessment: Erythema
Week 4
|
0.3 score on a scale
Interval 0.0 to 3.0
|
0.4 score on a scale
Interval 0.0 to 3.0
|
|
Treatment Tolerability Assessment: Erythema
Week 8
|
0.1 score on a scale
Interval 0.0 to 3.0
|
0.2 score on a scale
Interval 0.0 to 3.0
|
|
Treatment Tolerability Assessment: Erythema
Week 12
|
0.2 score on a scale
Interval 0.0 to 3.0
|
0.2 score on a scale
Interval 0.0 to 3.0
|
|
Treatment Tolerability Assessment: Erythema
Week 16
|
0.1 score on a scale
Interval 0.0 to 3.0
|
0.1 score on a scale
Interval 0.0 to 3.0
|
PRIMARY outcome
Timeframe: 16 weeksPopulation: Male and female 18-50 years old, mild to moderate acne vulgaris with \>15 inflammatory lesions (papules/pustules) and \>20 non-inflammatory lesions (black heads/white heads) on the face.
Participants were assessed for Edema on a 4-point ordinal scale where 0= none; 1= mild; 2= moderate; and 3= severe. Assessments were made at baseline and weeks, 2, 4, 8, and 12, with the regression phase assessment at week 16.
Outcome measures
| Measure |
Effaclar
n=26 Participants
Effaclar: Topical, (Benzoyl peroxide 5.5%) Bid, 12 weeks
|
Benzaclin
n=34 Participants
BenzaClin: Topical, 1% Clindamycin/5% Benzoyl Peroxide, BID, 12 weeks
|
|---|---|---|
|
Treatment Tolerability Assessment: Edema
Baseline
|
0.1 score on a scale
Interval 0.0 to 3.0
|
0.1 score on a scale
Interval 0.0 to 3.0
|
|
Treatment Tolerability Assessment: Edema
Week 2
|
0.2 score on a scale
Interval 0.0 to 3.0
|
0.2 score on a scale
Interval 0.0 to 3.0
|
|
Treatment Tolerability Assessment: Edema
Week 4
|
0.1 score on a scale
Interval 0.0 to 3.0
|
0.2 score on a scale
Interval 0.0 to 3.0
|
|
Treatment Tolerability Assessment: Edema
Week 8
|
0.0 score on a scale
Interval 0.0 to 3.0
|
0.1 score on a scale
Interval 0.0 to 3.0
|
|
Treatment Tolerability Assessment: Edema
Week 12
|
0.0 score on a scale
Interval 0.0 to 3.0
|
0.0 score on a scale
Interval 0.0 to 3.0
|
|
Treatment Tolerability Assessment: Edema
Week 16
|
0.0 score on a scale
Interval 0.0 to 3.0
|
0.0 score on a scale
Interval 0.0 to 3.0
|
PRIMARY outcome
Timeframe: 16 weeksPopulation: Male and female 18-50 years old, mild to moderate acne vulgaris with \>15 inflammatory lesions (papules/pustules) and \>20 non-inflammatory lesions (black heads/white heads) on the face.
Participants were assessed for Dryness on a 4-point ordinal scale where 0= none; 1= mild; 2= moderate; and 3= severe. Assessments were made at baseline and weeks, 2, 4, 8, and 12, with the regression phase assessment at week 16.
Outcome measures
| Measure |
Effaclar
n=26 Participants
Effaclar: Topical, (Benzoyl peroxide 5.5%) Bid, 12 weeks
|
Benzaclin
n=34 Participants
BenzaClin: Topical, 1% Clindamycin/5% Benzoyl Peroxide, BID, 12 weeks
|
|---|---|---|
|
Treatment Tolerability Assessment: Dryness
Baseline
|
0.4 score on a scale
Interval 0.0 to 3.0
|
0.2 score on a scale
Interval 0.0 to 3.0
|
|
Treatment Tolerability Assessment: Dryness
Week 2
|
0.9 score on a scale
Interval 0.0 to 3.0
|
0.7 score on a scale
Interval 0.0 to 3.0
|
|
Treatment Tolerability Assessment: Dryness
Week 4
|
0.6 score on a scale
Interval 0.0 to 3.0
|
0.3 score on a scale
Interval 0.0 to 3.0
|
|
Treatment Tolerability Assessment: Dryness
Week 8
|
0.2 score on a scale
Interval 0.0 to 3.0
|
0.2 score on a scale
Interval 0.0 to 3.0
|
|
Treatment Tolerability Assessment: Dryness
Week 12
|
0.2 score on a scale
Interval 0.0 to 3.0
|
0.2 score on a scale
Interval 0.0 to 3.0
|
|
Treatment Tolerability Assessment: Dryness
Week 16
|
0.0 score on a scale
Interval 0.0 to 3.0
|
0.0 score on a scale
Interval 0.0 to 3.0
|
PRIMARY outcome
Timeframe: 16 weeksPopulation: Male and female 18-50 years old, mild to moderate acne vulgaris with \>15 inflammatory lesions (papules/pustules) and \>20 non-inflammatory lesions (black heads/white heads) on the face.
Participants were assessed for Peeling on a 4-point ordinal scale where 0= none; 1= mild; 2= moderate; and 3= severe. Assessments were made at baseline and weeks, 2, 4, 8, and 12, with the regression phase assessment at week 16.
Outcome measures
| Measure |
Effaclar
n=26 Participants
Effaclar: Topical, (Benzoyl peroxide 5.5%) Bid, 12 weeks
|
Benzaclin
n=34 Participants
BenzaClin: Topical, 1% Clindamycin/5% Benzoyl Peroxide, BID, 12 weeks
|
|---|---|---|
|
Treatment Tolerability Assessment: Peeling
Baseline
|
0.1 score on a scale
Interval 0.0 to 3.0
|
0.0 score on a scale
Interval 0.0 to 3.0
|
|
Treatment Tolerability Assessment: Peeling
Week 2
|
0.5 score on a scale
Interval 0.0 to 3.0
|
0.6 score on a scale
Interval 0.0 to 3.0
|
|
Treatment Tolerability Assessment: Peeling
Week 4
|
0.5 score on a scale
Interval 0.0 to 3.0
|
0.3 score on a scale
Interval 0.0 to 3.0
|
|
Treatment Tolerability Assessment: Peeling
Week 8
|
0.1 score on a scale
Interval 0.0 to 3.0
|
0.2 score on a scale
Interval 0.0 to 3.0
|
|
Treatment Tolerability Assessment: Peeling
Week 12
|
0.1 score on a scale
Interval 0.0 to 3.0
|
0.1 score on a scale
Interval 0.0 to 3.0
|
|
Treatment Tolerability Assessment: Peeling
Week 16
|
0.0 score on a scale
Interval 0.0 to 3.0
|
0.0 score on a scale
Interval 0.0 to 3.0
|
PRIMARY outcome
Timeframe: 16 weeksPopulation: Male and female 18-50 years old, mild to moderate acne vulgaris with \>15 inflammatory lesions (papules/pustules) and \>20 non-inflammatory lesions (black heads/white heads) on the face.
The facial skin was assessed for skin tone (clarity) on a 10-point visual analog scale with 0 indicating a favorable rating and 9 indicating an unfavorable rating. Assessments were made at baseline and weeks, 2, 4, 8, and 12, with the regression phase assessment at week 16.
Outcome measures
| Measure |
Effaclar
n=26 Participants
Effaclar: Topical, (Benzoyl peroxide 5.5%) Bid, 12 weeks
|
Benzaclin
n=34 Participants
BenzaClin: Topical, 1% Clindamycin/5% Benzoyl Peroxide, BID, 12 weeks
|
|---|---|---|
|
Facial Skin Assessment: Skin Tone (Clarity)
Baseline
|
5.3 score on a scale
Interval 0.0 to 9.0
|
5.0 score on a scale
Interval 0.0 to 9.0
|
|
Facial Skin Assessment: Skin Tone (Clarity)
Week 2
|
4.6 score on a scale
Interval 0.0 to 9.0
|
4.4 score on a scale
Interval 0.0 to 9.0
|
|
Facial Skin Assessment: Skin Tone (Clarity)
Week 4
|
4.1 score on a scale
Interval 0.0 to 9.0
|
3.9 score on a scale
Interval 0.0 to 9.0
|
|
Facial Skin Assessment: Skin Tone (Clarity)
Week 8
|
3.3 score on a scale
Interval 0.0 to 9.0
|
3.2 score on a scale
Interval 0.0 to 9.0
|
|
Facial Skin Assessment: Skin Tone (Clarity)
Week 12
|
2.6 score on a scale
Interval 0.0 to 9.0
|
2.3 score on a scale
Interval 0.0 to 9.0
|
|
Facial Skin Assessment: Skin Tone (Clarity)
Week 16
|
2.7 score on a scale
Interval 0.0 to 9.0
|
2.7 score on a scale
Interval 0.0 to 9.0
|
PRIMARY outcome
Timeframe: 16 weeksPopulation: Male and female 18-50 years old, mild to moderate acne vulgaris with \>15 inflammatory lesions (papules/pustules) and \>20 non-inflammatory lesions (black heads/white heads) on the face.
The facial skin was assessed for skin smoothness on a 10-point visual analog scale with 0 indicating a favorable rating and 9 indicating an unfavorable rating. Assessments were made at baseline and weeks, 2, 4, 8, and 12, with the regression phase assessment at week 16.
Outcome measures
| Measure |
Effaclar
n=26 Participants
Effaclar: Topical, (Benzoyl peroxide 5.5%) Bid, 12 weeks
|
Benzaclin
n=34 Participants
BenzaClin: Topical, 1% Clindamycin/5% Benzoyl Peroxide, BID, 12 weeks
|
|---|---|---|
|
Facial Skin Assessment: Skin Smoothness
Baseline
|
5.0 score on a scale
Interval 0.0 to 9.0
|
4.9 score on a scale
Interval 0.0 to 9.0
|
|
Facial Skin Assessment: Skin Smoothness
Week 2
|
4.7 score on a scale
Interval 0.0 to 9.0
|
4.5 score on a scale
Interval 0.0 to 9.0
|
|
Facial Skin Assessment: Skin Smoothness
Week 4
|
4.2 score on a scale
Interval 0.0 to 9.0
|
3.5 score on a scale
Interval 0.0 to 9.0
|
|
Facial Skin Assessment: Skin Smoothness
Week 8
|
3.2 score on a scale
Interval 0.0 to 9.0
|
2.7 score on a scale
Interval 0.0 to 9.0
|
|
Facial Skin Assessment: Skin Smoothness
Week 12
|
2.3 score on a scale
Interval 0.0 to 9.0
|
2.1 score on a scale
Interval 0.0 to 9.0
|
|
Facial Skin Assessment: Skin Smoothness
Week 16
|
2.2 score on a scale
Interval 0.0 to 9.0
|
2.3 score on a scale
Interval 0.0 to 9.0
|
PRIMARY outcome
Timeframe: 16 weeksPopulation: Male and female 18-50 years old, mild to moderate acne vulgaris with \>15 inflammatory lesions (papules/pustules) and \>20 non-inflammatory lesions (black heads/white heads) on the face.
The facial skin was assessed for skin brightness on a 10-point visual analog scale with 0 indicating a favorable rating and 9 indicating an unfavorable rating. Assessments were made at baseline and weeks, 2, 4, 8, and 12, with the regression phase assessment at week 16.
Outcome measures
| Measure |
Effaclar
n=26 Participants
Effaclar: Topical, (Benzoyl peroxide 5.5%) Bid, 12 weeks
|
Benzaclin
n=34 Participants
BenzaClin: Topical, 1% Clindamycin/5% Benzoyl Peroxide, BID, 12 weeks
|
|---|---|---|
|
Facial Skin Assessment: Skin Brightness
Baseline
|
5.1 score on a scale
Interval 0.0 to 9.0
|
4.6 score on a scale
Interval 0.0 to 9.0
|
|
Facial Skin Assessment: Skin Brightness
Week 2
|
4.6 score on a scale
Interval 0.0 to 9.0
|
4.1 score on a scale
Interval 0.0 to 9.0
|
|
Facial Skin Assessment: Skin Brightness
Week 4
|
4.0 score on a scale
Interval 0.0 to 9.0
|
3.6 score on a scale
Interval 0.0 to 9.0
|
|
Facial Skin Assessment: Skin Brightness
Week 8
|
3.2 score on a scale
Interval 0.0 to 9.0
|
2.8 score on a scale
Interval 0.0 to 9.0
|
|
Facial Skin Assessment: Skin Brightness
Week 12
|
2.5 score on a scale
Interval 0.0 to 9.0
|
2.4 score on a scale
Interval 0.0 to 9.0
|
|
Facial Skin Assessment: Skin Brightness
Week 16
|
2.6 score on a scale
Interval 0.0 to 9.0
|
2.6 score on a scale
Interval 0.0 to 9.0
|
PRIMARY outcome
Timeframe: 16 weeksPopulation: Male and female 18-50 years old, mild to moderate acne vulgaris with \>15 inflammatory lesions (papules/pustules) and \>20 non-inflammatory lesions (black heads/white heads) on the face.
The facial skin was assessed for the appearance of pores on a 10-point visual analog scale,with 0 indicating a favorable rating and 9 indicating an unfavorable rating. Assessments were made at baseline and weeks, 2, 4, 8, and 12, with the regression phase assessment at week 16.
Outcome measures
| Measure |
Effaclar
n=26 Participants
Effaclar: Topical, (Benzoyl peroxide 5.5%) Bid, 12 weeks
|
Benzaclin
n=34 Participants
BenzaClin: Topical, 1% Clindamycin/5% Benzoyl Peroxide, BID, 12 weeks
|
|---|---|---|
|
Facial Skin Assessment: Appearance of Pores
Baseline
|
4.6 score on a scale
Interval 0.0 to 9.0
|
4.6 score on a scale
Interval 0.0 to 9.0
|
|
Facial Skin Assessment: Appearance of Pores
Week 2
|
4.3 score on a scale
Interval 0.0 to 9.0
|
4.5 score on a scale
Interval 0.0 to 9.0
|
|
Facial Skin Assessment: Appearance of Pores
Week 4
|
4.1 score on a scale
Interval 0.0 to 9.0
|
4.2 score on a scale
Interval 0.0 to 9.0
|
|
Facial Skin Assessment: Appearance of Pores
Week 8
|
3.5 score on a scale
Interval 0.0 to 9.0
|
3.6 score on a scale
Interval 0.0 to 9.0
|
|
Facial Skin Assessment: Appearance of Pores
Week 12
|
3.2 score on a scale
Interval 0.0 to 9.0
|
3.1 score on a scale
Interval 0.0 to 9.0
|
|
Facial Skin Assessment: Appearance of Pores
Week 16
|
3.1 score on a scale
Interval 0.0 to 9.0
|
3.3 score on a scale
Interval 0.0 to 9.0
|
PRIMARY outcome
Timeframe: 16 weeksPopulation: Male and female 18-50 years old, mild to moderate acne vulgaris with \>15 inflammatory lesions (papules/pustules) and \>20 non-inflammatory lesions (black heads/white heads) on the face.
The facial skin was assessed for overall appearance on a 10-point visual analog scale with 0 indicating a favorable rating and 9 indicating an unfavorable rating. Assessments were made at baseline and weeks, 2, 4, 8, and 12, with the regression phase assessment at week 16.
Outcome measures
| Measure |
Effaclar
n=26 Participants
Effaclar: Topical, (Benzoyl peroxide 5.5%) Bid, 12 weeks
|
Benzaclin
n=34 Participants
BenzaClin: Topical, 1% Clindamycin/5% Benzoyl Peroxide, BID, 12 weeks
|
|---|---|---|
|
Facial Skin Assessment: Overall Appearance
Baseline
|
5.1 score on a scale
Interval 0.0 to 9.0
|
5.0 score on a scale
Interval 0.0 to 9.0
|
|
Facial Skin Assessment: Overall Appearance
Week 2
|
4.7 score on a scale
Interval 0.0 to 9.0
|
4.4 score on a scale
Interval 0.0 to 9.0
|
|
Facial Skin Assessment: Overall Appearance
Week 4
|
4.3 score on a scale
Interval 0.0 to 9.0
|
3.9 score on a scale
Interval 0.0 to 9.0
|
|
Facial Skin Assessment: Overall Appearance
Week 8
|
3.2 score on a scale
Interval 0.0 to 9.0
|
3.1 score on a scale
Interval 0.0 to 9.0
|
|
Facial Skin Assessment: Overall Appearance
Week 12
|
2.6 score on a scale
Interval 0.0 to 9.0
|
2.4 score on a scale
Interval 0.0 to 9.0
|
|
Facial Skin Assessment: Overall Appearance
Week 16
|
2.5 score on a scale
Interval 0.0 to 9.0
|
2.6 score on a scale
Interval 0.0 to 9.0
|
PRIMARY outcome
Timeframe: 16 weeksPopulation: Male and female 18-50 years old, mild to moderate acne vulgaris with \>15 inflammatory lesions (papules/pustules) and \>20 non-inflammatory lesions (black heads/white heads) on the face.
The facial skin was assessed for global acne assessment on a 10-point visual analog scale with 0 indicating a favorable rating and 9 indicating an unfavorable rating. Assessments were made at baseline and weeks, 2, 4, 8, and 12, with the regression phase assessment at week 16.
Outcome measures
| Measure |
Effaclar
n=26 Participants
Effaclar: Topical, (Benzoyl peroxide 5.5%) Bid, 12 weeks
|
Benzaclin
n=34 Participants
BenzaClin: Topical, 1% Clindamycin/5% Benzoyl Peroxide, BID, 12 weeks
|
|---|---|---|
|
Facial Skin Assessment: Global Acne Assessment
Baseline
|
3.4 score on a scale
Interval 0.0 to 9.0
|
3.1 score on a scale
Interval 0.0 to 9.0
|
|
Facial Skin Assessment: Global Acne Assessment
Week 2
|
3.1 score on a scale
Interval 0.0 to 9.0
|
2.7 score on a scale
Interval 0.0 to 9.0
|
|
Facial Skin Assessment: Global Acne Assessment
Week 4
|
2.5 score on a scale
Interval 0.0 to 9.0
|
2.3 score on a scale
Interval 0.0 to 9.0
|
|
Facial Skin Assessment: Global Acne Assessment
Week 8
|
2.2 score on a scale
Interval 0.0 to 9.0
|
2.1 score on a scale
Interval 0.0 to 9.0
|
|
Facial Skin Assessment: Global Acne Assessment
Week 12
|
1.7 score on a scale
Interval 0.0 to 9.0
|
1.7 score on a scale
Interval 0.0 to 9.0
|
|
Facial Skin Assessment: Global Acne Assessment
Week 16
|
2.2 score on a scale
Interval 0.0 to 9.0
|
2.0 score on a scale
Interval 0.0 to 9.0
|
PRIMARY outcome
Timeframe: 16 weeksPopulation: Male and female 18-50 years old, mild to moderate acne vulgaris with \>15 inflammatory lesions (papules/pustules) and \>20 non-inflammatory lesions (black heads/white heads) on the face.
Participants were assessed for facial open comedomes and the total number present was recorded. Assessments were made at baseline and weeks, 2, 4, 8, and 12, with the regression phase assessment at week 16.
Outcome measures
| Measure |
Effaclar
n=26 Participants
Effaclar: Topical, (Benzoyl peroxide 5.5%) Bid, 12 weeks
|
Benzaclin
n=34 Participants
BenzaClin: Topical, 1% Clindamycin/5% Benzoyl Peroxide, BID, 12 weeks
|
|---|---|---|
|
Facial Lesion Counts: Open Comedones
Baseline
|
8.4 Open Comedone Count
Interval 1.0 to 24.0
|
8.3 Open Comedone Count
Interval 1.0 to 24.0
|
|
Facial Lesion Counts: Open Comedones
Week 2
|
5.3 Open Comedone Count
Interval 1.0 to 12.0
|
4.8 Open Comedone Count
Interval 1.0 to 12.0
|
|
Facial Lesion Counts: Open Comedones
Week 4
|
3.2 Open Comedone Count
Interval 1.0 to 12.0
|
3.6 Open Comedone Count
Interval 1.0 to 12.0
|
|
Facial Lesion Counts: Open Comedones
Week 8
|
2.9 Open Comedone Count
Interval 1.0 to 9.0
|
3.5 Open Comedone Count
Interval 1.0 to 9.0
|
|
Facial Lesion Counts: Open Comedones
Week 12
|
1.3 Open Comedone Count
Interval 0.0 to 5.0
|
0.9 Open Comedone Count
Interval 0.0 to 5.0
|
|
Facial Lesion Counts: Open Comedones
Week 16
|
2.0 Open Comedone Count
Interval 0.0 to 5.0
|
0.8 Open Comedone Count
Interval 0.0 to 5.0
|
PRIMARY outcome
Timeframe: 16 weeksPopulation: Male and female 18-50 years old, mild to moderate acne vulgaris with \>15 inflammatory lesions (papules/pustules) and \>20 non-inflammatory lesions (black heads/white heads) on the face.
Participants were assessed for facial closed comedomes and the total number present was recorded. Assessments were made at baseline and weeks, 2, 4, 8, and 12, with the regression phase assessment at week 16.
Outcome measures
| Measure |
Effaclar
n=26 Participants
Effaclar: Topical, (Benzoyl peroxide 5.5%) Bid, 12 weeks
|
Benzaclin
n=34 Participants
BenzaClin: Topical, 1% Clindamycin/5% Benzoyl Peroxide, BID, 12 weeks
|
|---|---|---|
|
Facial Lesion Counts: Closed Comedones
Baseline
|
22.5 Closed Comedone Count
Interval 5.0 to 38.0
|
23 Closed Comedone Count
Interval 5.0 to 38.0
|
|
Facial Lesion Counts: Closed Comedones
Week 2
|
16.0 Closed Comedone Count
Interval 5.0 to 24.0
|
14.8 Closed Comedone Count
Interval 7.0 to 22.0
|
|
Facial Lesion Counts: Closed Comedones
Week 4
|
9.8 Closed Comedone Count
Interval 1.0 to 15.0
|
13.7 Closed Comedone Count
Interval 1.0 to 17.0
|
|
Facial Lesion Counts: Closed Comedones
Week 8
|
8.3 Closed Comedone Count
Interval 1.0 to 21.0
|
9.8 Closed Comedone Count
Interval 1.0 to 14.0
|
|
Facial Lesion Counts: Closed Comedones
Week 12
|
6.4 Closed Comedone Count
Interval 0.0 to 11.0
|
8.4 Closed Comedone Count
Interval 0.0 to 15.0
|
|
Facial Lesion Counts: Closed Comedones
Week 16
|
9.4 Closed Comedone Count
Interval 0.0 to 12.0
|
10.0 Closed Comedone Count
Interval 0.0 to 17.0
|
PRIMARY outcome
Timeframe: 16 weeksPopulation: Male and female 18-50 years old, mild to moderate acne vulgaris with \>15 inflammatory lesions (papules/pustules) and \>20 non-inflammatory lesions (black heads/white heads) on the face.
Participants were assessed for facial open comedomes and the total number present was recorded. Assessments were made at baseline and weeks, 2, 4, 8, and 12, with the regression phase assessment at week 16.
Outcome measures
| Measure |
Effaclar
n=26 Participants
Effaclar: Topical, (Benzoyl peroxide 5.5%) Bid, 12 weeks
|
Benzaclin
n=34 Participants
BenzaClin: Topical, 1% Clindamycin/5% Benzoyl Peroxide, BID, 12 weeks
|
|---|---|---|
|
Facial Lesion Counts: Papules
Baseline
|
17.4 Papule Count
Interval 6.0 to 26.0
|
15.7 Papule Count
Interval 4.0 to 25.0
|
|
Facial Lesion Counts: Papules
Week 2
|
12.0 Papule Count
Interval 2.0 to 19.0
|
9.0 Papule Count
Interval 3.0 to 14.0
|
|
Facial Lesion Counts: Papules
Week 4
|
8.0 Papule Count
Interval 1.0 to 16.0
|
6.6 Papule Count
Interval 1.0 to 10.0
|
|
Facial Lesion Counts: Papules
Week 8
|
6.4 Papule Count
Interval 1.0 to 9.0
|
5.8 Papule Count
Interval 1.0 to 9.0
|
|
Facial Lesion Counts: Papules
Week 12
|
5.3 Papule Count
Interval 1.0 to 9.0
|
4.0 Papule Count
Interval 1.0 to 7.0
|
|
Facial Lesion Counts: Papules
Week 16
|
6.8 Papule Count
Interval 1.0 to 11.0
|
4.5 Papule Count
Interval 1.0 to 7.0
|
PRIMARY outcome
Timeframe: 16 weeksPopulation: Male and female 18-50 years old, mild to moderate acne vulgaris with \>15 inflammatory lesions (papules/pustules) and \>20 non-inflammatory lesions (black heads/white heads) on the face.
Participants were assessed for facial pustules and the total number present was recorded. Assessments were made at baseline and weeks, 2, 4, 8, and 12, with the regression phase assessment at week 16.
Outcome measures
| Measure |
Effaclar
n=26 Participants
Effaclar: Topical, (Benzoyl peroxide 5.5%) Bid, 12 weeks
|
Benzaclin
n=34 Participants
BenzaClin: Topical, 1% Clindamycin/5% Benzoyl Peroxide, BID, 12 weeks
|
|---|---|---|
|
Facial Lesion Counts: Pustules
Baseline
|
3.6 Pustules Count
Interval 0.0 to 8.0
|
3.9 Pustules Count
Interval 0.0 to 8.0
|
|
Facial Lesion Counts: Pustules
Week 2
|
2.3 Pustules Count
Interval 0.0 to 8.0
|
1.4 Pustules Count
Interval 0.0 to 5.0
|
|
Facial Lesion Counts: Pustules
Week 4
|
1.4 Pustules Count
Interval 0.0 to 5.0
|
1.3 Pustules Count
Interval 0.0 to 5.0
|
|
Facial Lesion Counts: Pustules
Week 8
|
0.8 Pustules Count
Interval 0.0 to 4.0
|
0.9 Pustules Count
Interval 0.0 to 4.0
|
|
Facial Lesion Counts: Pustules
Week 12
|
0.5 Pustules Count
Interval 0.0 to 4.0
|
0.5 Pustules Count
Interval 0.0 to 4.0
|
|
Facial Lesion Counts: Pustules
Week 16
|
1.0 Pustules Count
Interval 0.0 to 4.0
|
1.7 Pustules Count
Interval 0.0 to 5.0
|
PRIMARY outcome
Timeframe: 16 weeksPopulation: Male and female 18-50 years old, mild to moderate acne vulgaris with \>15 inflammatory lesions (papules/pustules) and \>20 non-inflammatory lesions (black heads/white heads) on the face.
Participants were assessed for facial noninflammatory lesions and the total number present was recorded. Assessments were made at baseline and weeks, 2, 4, 8, and 12, with the regression phase assessment at week 16.
Outcome measures
| Measure |
Effaclar
n=26 Participants
Effaclar: Topical, (Benzoyl peroxide 5.5%) Bid, 12 weeks
|
Benzaclin
n=34 Participants
BenzaClin: Topical, 1% Clindamycin/5% Benzoyl Peroxide, BID, 12 weeks
|
|---|---|---|
|
Facial Lesion Counts: Noninflammatory Lesions
Baseline
|
30.9 Noninflammatory Lesion Count
Interval 6.0 to 61.0
|
31.3 Noninflammatory Lesion Count
Interval 10.0 to 65.0
|
|
Facial Lesion Counts: Noninflammatory Lesions
Week 2
|
21.3 Noninflammatory Lesion Count
Interval 5.0 to 48.0
|
19.6 Noninflammatory Lesion Count
Interval 5.0 to 48.0
|
|
Facial Lesion Counts: Noninflammatory Lesions
Week 4
|
13.0 Noninflammatory Lesion Count
Interval 2.0 to 26.0
|
17.3 Noninflammatory Lesion Count
Interval 4.0 to 31.0
|
|
Facial Lesion Counts: Noninflammatory Lesions
Week 8
|
11.2 Noninflammatory Lesion Count
Interval 0.0 to 17.0
|
13.3 Noninflammatory Lesion Count
Interval 0.0 to 20.0
|
|
Facial Lesion Counts: Noninflammatory Lesions
Week 12
|
7.7 Noninflammatory Lesion Count
Interval 0.0 to 11.0
|
9.3 Noninflammatory Lesion Count
Interval 0.0 to 21.0
|
|
Facial Lesion Counts: Noninflammatory Lesions
Week 16
|
11.4 Noninflammatory Lesion Count
Interval 0.0 to 19.0
|
10.9 Noninflammatory Lesion Count
Interval 0.0 to 22.0
|
PRIMARY outcome
Timeframe: 16 weeksPopulation: Male and female 18-50 years old, mild to moderate acne vulgaris with \>15 inflammatory lesions (papules/pustules) and \>20 non-inflammatory lesions (black heads/white heads) on the face.
Participants were assessed for facial inflammatory lesions and the total number present was recorded. Assessments were made at baseline and weeks, 2, 4, 8, and 12, with the regression phase assessment at week 16.
Outcome measures
| Measure |
Effaclar
n=26 Participants
Effaclar: Topical, (Benzoyl peroxide 5.5%) Bid, 12 weeks
|
Benzaclin
n=34 Participants
BenzaClin: Topical, 1% Clindamycin/5% Benzoyl Peroxide, BID, 12 weeks
|
|---|---|---|
|
Facial Lesion Counts: Inflammatory Lesions
Baseline
|
21.0 Inflammatory Lesion Count
Interval 6.0 to 32.0
|
19.6 Inflammatory Lesion Count
Interval 5.0 to 27.0
|
|
Facial Lesion Counts: Inflammatory Lesions
Week 2
|
14.3 Inflammatory Lesion Count
Interval 5.0 to 22.0
|
10.4 Inflammatory Lesion Count
Interval 2.0 to 14.0
|
|
Facial Lesion Counts: Inflammatory Lesions
Week 4
|
9.4 Inflammatory Lesion Count
Interval 2.0 to 16.0
|
7.9 Inflammatory Lesion Count
Interval 2.0 to 15.0
|
|
Facial Lesion Counts: Inflammatory Lesions
Week 8
|
7.2 Inflammatory Lesion Count
Interval 0.0 to 12.0
|
6.7 Inflammatory Lesion Count
Interval 0.0 to 10.0
|
|
Facial Lesion Counts: Inflammatory Lesions
Week 12
|
5.8 Inflammatory Lesion Count
Interval 0.0 to 8.0
|
4.4 Inflammatory Lesion Count
Interval 0.0 to 6.0
|
|
Facial Lesion Counts: Inflammatory Lesions
Week 16
|
7.7 Inflammatory Lesion Count
Interval 0.0 to 12.0
|
6.2 Inflammatory Lesion Count
Interval 0.0 to 9.0
|
PRIMARY outcome
Timeframe: 16 weeksPopulation: Male and female 18-50 years old, mild to moderate acne vulgaris with \>15 inflammatory lesions (papules/pustules) and \>20 non-inflammatory lesions (black heads/white heads) on the face.
Participants were assessed for all facial lesions and the total number present was recorded. Assessments were made at baseline and weeks, 2, 4, 8, and 12, with the regression phase assessment at week 16.
Outcome measures
| Measure |
Effaclar
n=26 Participants
Effaclar: Topical, (Benzoyl peroxide 5.5%) Bid, 12 weeks
|
Benzaclin
n=34 Participants
BenzaClin: Topical, 1% Clindamycin/5% Benzoyl Peroxide, BID, 12 weeks
|
|---|---|---|
|
Facial Lesion Counts: Total Lesion
Baseline
|
51.9 Total Lesion Count
Interval 12.0 to 66.0
|
51.0 Total Lesion Count
Interval 18.0 to 72.0
|
|
Facial Lesion Counts: Total Lesion
Week 2
|
35.6 Total Lesion Count
Interval 10.0 to 59.0
|
30.0 Total Lesion Count
Interval 8.0 to 48.0
|
|
Facial Lesion Counts: Total Lesion
Week 4
|
22.5 Total Lesion Count
Interval 10.0 to 48.0
|
25.1 Total Lesion Count
Interval 13.0 to 56.0
|
|
Facial Lesion Counts: Total Lesion
Week 8
|
18.5 Total Lesion Count
Interval 2.0 to 31.0
|
20.0 Total Lesion Count
Interval 5.0 to 25.0
|
|
Facial Lesion Counts: Total Lesion
Week 12
|
13.5 Total Lesion Count
Interval 2.0 to 22.0
|
13.7 Total Lesion Count
Interval 3.0 to 27.0
|
|
Facial Lesion Counts: Total Lesion
Week 16
|
19.0 Total Lesion Count
Interval 5.0 to 34.0
|
17.0 Total Lesion Count
Interval 2.0 to 32.0
|
PRIMARY outcome
Timeframe: 16 weeksPopulation: Male and female 18-50 years old, mild to moderate acne vulgaris with \>15 inflammatory lesions (papules/pustules) and \>20 non-inflammatory lesions (black heads/white heads) on the face.
Irritation stinging was subjectively reported by participants and captured on a 4 point ordinal scale (0= none; 1= mild; 2= moderate; 3= severe). Assessments were made at baseline and weeks, 2, 4, 8, and 12, with the regression phase assessment at week 16.
Outcome measures
| Measure |
Effaclar
n=26 Participants
Effaclar: Topical, (Benzoyl peroxide 5.5%) Bid, 12 weeks
|
Benzaclin
n=34 Participants
BenzaClin: Topical, 1% Clindamycin/5% Benzoyl Peroxide, BID, 12 weeks
|
|---|---|---|
|
Subjective Tolerability of Irritation Assessment (Participant Assessed): Stinging
Baseline
|
0.1 score on a scale
Interval 0.0 to 3.0
|
0.0 score on a scale
Interval 0.0 to 3.0
|
|
Subjective Tolerability of Irritation Assessment (Participant Assessed): Stinging
Week 2
|
0.8 score on a scale
Interval 0.0 to 3.0
|
0.8 score on a scale
Interval 0.0 to 3.0
|
|
Subjective Tolerability of Irritation Assessment (Participant Assessed): Stinging
Week 4
|
0.4 score on a scale
Interval 0.0 to 3.0
|
0.4 score on a scale
Interval 0.0 to 3.0
|
|
Subjective Tolerability of Irritation Assessment (Participant Assessed): Stinging
Week 8
|
0.3 score on a scale
Interval 0.0 to 3.0
|
0.5 score on a scale
Interval 0.0 to 3.0
|
|
Subjective Tolerability of Irritation Assessment (Participant Assessed): Stinging
Week 12
|
0.2 score on a scale
Interval 0.0 to 3.0
|
0.3 score on a scale
Interval 0.0 to 3.0
|
|
Subjective Tolerability of Irritation Assessment (Participant Assessed): Stinging
Week 16
|
0.1 score on a scale
Interval 0.0 to 3.0
|
0.2 score on a scale
Interval 0.0 to 3.0
|
PRIMARY outcome
Timeframe: 16 weeksPopulation: Male and female 18-50 years old, mild to moderate acne vulgaris with \>15 inflammatory lesions (papules/pustules) and \>20 non-inflammatory lesions (black heads/white heads) on the face.
Irritation tingling was subjectively reported by participants and captured on a 4 point ordinal scale (0= none; 1= mild; 2= moderate; 3= severe). Assessments were made at baseline and weeks, 2, 4, 8, and 12, with the regression phase assessment at week 16.
Outcome measures
| Measure |
Effaclar
n=26 Participants
Effaclar: Topical, (Benzoyl peroxide 5.5%) Bid, 12 weeks
|
Benzaclin
n=34 Participants
BenzaClin: Topical, 1% Clindamycin/5% Benzoyl Peroxide, BID, 12 weeks
|
|---|---|---|
|
Subjective Tolerability of Irritation Assessment (Participant Assessed): Tingling
Baseline
|
0.1 score on a scale
Interval 0.0 to 3.0
|
0.0 score on a scale
Interval 0.0 to 3.0
|
|
Subjective Tolerability of Irritation Assessment (Participant Assessed): Tingling
Week 2
|
0.8 score on a scale
Interval 0.0 to 3.0
|
0.8 score on a scale
Interval 0.0 to 3.0
|
|
Subjective Tolerability of Irritation Assessment (Participant Assessed): Tingling
Week 4
|
0.4 score on a scale
Interval 0.0 to 3.0
|
0.4 score on a scale
Interval 0.0 to 3.0
|
|
Subjective Tolerability of Irritation Assessment (Participant Assessed): Tingling
Week 8
|
0.3 score on a scale
Interval 0.0 to 3.0
|
0.5 score on a scale
Interval 0.0 to 3.0
|
|
Subjective Tolerability of Irritation Assessment (Participant Assessed): Tingling
Week 12
|
0.2 score on a scale
Interval 0.0 to 3.0
|
0.3 score on a scale
Interval 0.0 to 3.0
|
|
Subjective Tolerability of Irritation Assessment (Participant Assessed): Tingling
Week 16
|
0.1 score on a scale
Interval 0.0 to 3.0
|
0.2 score on a scale
Interval 0.0 to 3.0
|
PRIMARY outcome
Timeframe: 16 weeksPopulation: Male and female 18-50 years old, mild to moderate acne vulgaris with \>15 inflammatory lesions (papules/pustules) and \>20 non-inflammatory lesions (black heads/white heads) on the face.
Irritation itching was subjectively reported by participants and captured on a 4 point ordinal scale (0= none; 1= mild; 2= moderate; 3= severe). Assessments were made at baseline and weeks, 2, 4, 8, and 12, with the regression phase assessment at week 16.
Outcome measures
| Measure |
Effaclar
n=26 Participants
Effaclar: Topical, (Benzoyl peroxide 5.5%) Bid, 12 weeks
|
Benzaclin
n=34 Participants
BenzaClin: Topical, 1% Clindamycin/5% Benzoyl Peroxide, BID, 12 weeks
|
|---|---|---|
|
Subjective Tolerability of Irritation Assessment (Participant Assessed): Itching
Baseline
|
0.2 score on a scale
Interval 0.0 to 3.0
|
0.1 score on a scale
Interval 0.0 to 3.0
|
|
Subjective Tolerability of Irritation Assessment (Participant Assessed): Itching
Week 2
|
0.5 score on a scale
Interval 0.0 to 3.0
|
0.5 score on a scale
Interval 0.0 to 3.0
|
|
Subjective Tolerability of Irritation Assessment (Participant Assessed): Itching
Week 4
|
0.4 score on a scale
Interval 0.0 to 3.0
|
0.4 score on a scale
Interval 0.0 to 3.0
|
|
Subjective Tolerability of Irritation Assessment (Participant Assessed): Itching
Week 8
|
0.3 score on a scale
Interval 0.0 to 3.0
|
0.3 score on a scale
Interval 0.0 to 3.0
|
|
Subjective Tolerability of Irritation Assessment (Participant Assessed): Itching
Week 12
|
0.2 score on a scale
Interval 0.0 to 3.0
|
0.3 score on a scale
Interval 0.0 to 3.0
|
|
Subjective Tolerability of Irritation Assessment (Participant Assessed): Itching
Week 16
|
0.1 score on a scale
Interval 0.0 to 3.0
|
0.3 score on a scale
Interval 0.0 to 3.0
|
PRIMARY outcome
Timeframe: 16 weeksPopulation: Male and female 18-50 years old, mild to moderate acne vulgaris with \>15 inflammatory lesions (papules/pustules) and \>20 non-inflammatory lesions (black heads/white heads) on the face.
Irritation burning was subjectively reported by participants and captured on a 4 point ordinal scale (0= none; 1= mild; 2= moderate; 3= severe). Assessments were made at baseline and weeks, 2, 4, 8, and 12, with the regression phase assessment at week 16.
Outcome measures
| Measure |
Effaclar
n=26 Participants
Effaclar: Topical, (Benzoyl peroxide 5.5%) Bid, 12 weeks
|
Benzaclin
n=34 Participants
BenzaClin: Topical, 1% Clindamycin/5% Benzoyl Peroxide, BID, 12 weeks
|
|---|---|---|
|
Subjective Tolerability of Irritation Assessment (Participant Assessed): Burning
Baseline
|
0.2 score on a scale
Interval 0.0 to 3.0
|
0.1 score on a scale
Interval 0.0 to 3.0
|
|
Subjective Tolerability of Irritation Assessment (Participant Assessed): Burning
Week 2
|
1.1 score on a scale
Interval 0.0 to 3.0
|
1.0 score on a scale
Interval 0.0 to 3.0
|
|
Subjective Tolerability of Irritation Assessment (Participant Assessed): Burning
Week 4
|
0.6 score on a scale
Interval 0.0 to 3.0
|
0.4 score on a scale
Interval 0.0 to 3.0
|
|
Subjective Tolerability of Irritation Assessment (Participant Assessed): Burning
Week 8
|
0.5 score on a scale
Interval 0.0 to 3.0
|
0.5 score on a scale
Interval 0.0 to 3.0
|
|
Subjective Tolerability of Irritation Assessment (Participant Assessed): Burning
Week 12
|
0.3 score on a scale
Interval 0.0 to 3.0
|
0.4 score on a scale
Interval 0.0 to 3.0
|
|
Subjective Tolerability of Irritation Assessment (Participant Assessed): Burning
Week 16
|
0.0 score on a scale
Interval 0.0 to 3.0
|
0.1 score on a scale
Interval 0.0 to 3.0
|
Adverse Events
Effaclar
BenzaClin
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place