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Comparing OTC Acne Treatment to Prescription Regimen

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: NCT01237821
Recruitment Status : Completed
First Posted : November 10, 2010
Results First Posted : July 16, 2019
Last Update Posted : July 16, 2019
Sponsor:
Collaborator:
Loreal USA
Information provided by (Responsible Party):
Amy Longenecker, Milton S. Hershey Medical Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Acne Vulgaris
Interventions Drug: BenzaClin
Drug: Effaclar
Enrollment 66
Recruitment Details  
Pre-assignment Details  
Arm/Group Title BenzaClin Effaclar
Hide Arm/Group Description

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

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

Period Title: Overall Study
Started 32 34
Completed 26 34
Not Completed 6 0
Arm/Group Title BenzaClin Effaclar Total
Hide Arm/Group Description

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

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 of all reporting groups
Overall Number of Baseline Participants 26 34 60
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 participants 34 participants 60 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
26
 100.0%
34
 100.0%
60
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 26 participants 34 participants 60 participants
29.53  (9.81) 32.41  (9.30) 30.92  (9.60)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 participants 34 participants 60 participants
Female
20
  76.9%
28
  82.4%
48
  80.0%
Male
6
  23.1%
6
  17.6%
12
  20.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 26 participants 34 participants 60 participants
26 34 66
1.Primary Outcome
Title Treatment Tolerability Assessment: Erythema
Hide Description 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.
Time Frame 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Effaclar Benzaclin
Hide Arm/Group Description:
Effaclar: Topical, (Benzoyl peroxide 5.5%) Bid, 12 weeks
BenzaClin: Topical, 1% Clindamycin/5% Benzoyl Peroxide, BID, 12 weeks
Overall Number of Participants Analyzed 26 34
Mean (Full Range)
Unit of Measure: score on a scale
Baseline
0.3
(0 to 3)
0.4
(0 to 3)
Week 2
0.6
(0 to 3)
0.4
(0 to 3)
Week 4
0.3
(0 to 3)
0.4
(0 to 3)
Week 8
0.1
(0 to 3)
0.2
(0 to 3)
Week 12
0.2
(0 to 3)
0.2
(0 to 3)
Week 16
0.1
(0 to 3)
0.1
(0 to 3)
2.Primary Outcome
Title Treatment Tolerability Assessment: Edema
Hide Description 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.
Time Frame 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Effaclar Benzaclin
Hide Arm/Group Description:
Effaclar: Topical, (Benzoyl peroxide 5.5%) Bid, 12 weeks
BenzaClin: Topical, 1% Clindamycin/5% Benzoyl Peroxide, BID, 12 weeks
Overall Number of Participants Analyzed 26 34
Mean (Full Range)
Unit of Measure: score on a scale
Baseline
0.1
(0 to 3)
0.1
(0 to 3)
Week 2
0.2
(0 to 3)
0.2
(0 to 3)
Week 4
0.1
(0 to 3)
0.2
(0 to 3)
Week 8
0.0
(0 to 3)
0.1
(0 to 3)
Week 12
0.0
(0 to 3)
0.0
(0 to 3)
Week 16
0.0
(0 to 3)
0.0
(0 to 3)
3.Primary Outcome
Title Treatment Tolerability Assessment: Dryness
Hide Description 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.
Time Frame 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Effaclar Benzaclin
Hide Arm/Group Description:
Effaclar: Topical, (Benzoyl peroxide 5.5%) Bid, 12 weeks
BenzaClin: Topical, 1% Clindamycin/5% Benzoyl Peroxide, BID, 12 weeks
Overall Number of Participants Analyzed 26 34
Mean (Full Range)
Unit of Measure: score on a scale
Baseline
0.4
(0 to 3)
0.2
(0 to 3)
Week 2
0.9
(0 to 3)
0.7
(0 to 3)
Week 4
0.6
(0 to 3)
0.3
(0 to 3)
Week 8
0.2
(0 to 3)
0.2
(0 to 3)
Week 12
0.2
(0 to 3)
0.2
(0 to 3)
Week 16
0.0
(0 to 3)
0.0
(0 to 3)
4.Primary Outcome
Title Treatment Tolerability Assessment: Peeling
Hide Description 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.
Time Frame 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Effaclar Benzaclin
Hide Arm/Group Description:
Effaclar: Topical, (Benzoyl peroxide 5.5%) Bid, 12 weeks
BenzaClin: Topical, 1% Clindamycin/5% Benzoyl Peroxide, BID, 12 weeks
Overall Number of Participants Analyzed 26 34
Mean (Full Range)
Unit of Measure: score on a scale
Baseline
0.1
(0 to 3)
0.0
(0 to 3)
Week 2
0.5
(0 to 3)
0.6
(0 to 3)
Week 4
0.5
(0 to 3)
0.3
(0 to 3)
Week 8
0.1
(0 to 3)
0.2
(0 to 3)
Week 12
0.1
(0 to 3)
0.1
(0 to 3)
Week 16
0.0
(0 to 3)
0.0
(0 to 3)
5.Primary Outcome
Title Facial Skin Assessment: Skin Tone (Clarity)
Hide Description 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.
Time Frame 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Effaclar Benzaclin
Hide Arm/Group Description:
Effaclar: Topical, (Benzoyl peroxide 5.5%) Bid, 12 weeks
BenzaClin: Topical, 1% Clindamycin/5% Benzoyl Peroxide, BID, 12 weeks
Overall Number of Participants Analyzed 26 34
Mean (Full Range)
Unit of Measure: score on a scale
Baseline
5.3
(0 to 9)
5.0
(0 to 9)
Week 2
4.6
(0 to 9)
4.4
(0 to 9)
Week 4
4.1
(0 to 9)
3.9
(0 to 9)
Week 8
3.3
(0 to 9)
3.2
(0 to 9)
Week 12
2.6
(0 to 9)
2.3
(0 to 9)
Week 16
2.7
(0 to 9)
2.7
(0 to 9)
6.Primary Outcome
Title Facial Skin Assessment: Skin Smoothness
Hide Description 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.
Time Frame 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Effaclar Benzaclin
Hide Arm/Group Description:
Effaclar: Topical, (Benzoyl peroxide 5.5%) Bid, 12 weeks
BenzaClin: Topical, 1% Clindamycin/5% Benzoyl Peroxide, BID, 12 weeks
Overall Number of Participants Analyzed 26 34
Mean (Full Range)
Unit of Measure: score on a scale
Baseline
5.0
(0 to 9)
4.9
(0 to 9)
Week 2
4.7
(0 to 9)
4.5
(0 to 9)
Week 4
4.2
(0 to 9)
3.5
(0 to 9)
Week 8
3.2
(0 to 9)
2.7
(0 to 9)
Week 12
2.3
(0 to 9)
2.1
(0 to 9)
Week 16
2.2
(0 to 9)
2.3
(0 to 9)
7.Primary Outcome
Title Facial Skin Assessment: Skin Brightness
Hide Description 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.
Time Frame 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Effaclar Benzaclin
Hide Arm/Group Description:
Effaclar: Topical, (Benzoyl peroxide 5.5%) Bid, 12 weeks
BenzaClin: Topical, 1% Clindamycin/5% Benzoyl Peroxide, BID, 12 weeks
Overall Number of Participants Analyzed 26 34
Mean (Full Range)
Unit of Measure: score on a scale
Baseline
5.1
(0 to 9)
4.6
(0 to 9)
Week 2
4.6
(0 to 9)
4.1
(0 to 9)
Week 4
4.0
(0 to 9)
3.6
(0 to 9)
Week 8
3.2
(0 to 9)
2.8
(0 to 9)
Week 12
2.5
(0 to 9)
2.4
(0 to 9)
Week 16
2.6
(0 to 9)
2.6
(0 to 9)
8.Primary Outcome
Title Facial Skin Assessment: Appearance of Pores
Hide Description 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.
Time Frame 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Effaclar Benzaclin
Hide Arm/Group Description:
Effaclar: Topical, (Benzoyl peroxide 5.5%) Bid, 12 weeks
BenzaClin: Topical, 1% Clindamycin/5% Benzoyl Peroxide, BID, 12 weeks
Overall Number of Participants Analyzed 26 34
Mean (Full Range)
Unit of Measure: score on a scale
Baseline
4.6
(0 to 9)
4.6
(0 to 9)
Week 2
4.3
(0 to 9)
4.5
(0 to 9)
Week 4
4.1
(0 to 9)
4.2
(0 to 9)
Week 8
3.5
(0 to 9)
3.6
(0 to 9)
Week 12
3.2
(0 to 9)
3.1
(0 to 9)
Week 16
3.1
(0 to 9)
3.3
(0 to 9)
9.Primary Outcome
Title Facial Skin Assessment: Overall Appearance
Hide Description 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.
Time Frame 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Effaclar Benzaclin
Hide Arm/Group Description:
Effaclar: Topical, (Benzoyl peroxide 5.5%) Bid, 12 weeks
BenzaClin: Topical, 1% Clindamycin/5% Benzoyl Peroxide, BID, 12 weeks
Overall Number of Participants Analyzed 26 34
Mean (Full Range)
Unit of Measure: score on a scale
Baseline
5.1
(0 to 9)
5.0
(0 to 9)
Week 2
4.7
(0 to 9)
4.4
(0 to 9)
Week 4
4.3
(0 to 9)
3.9
(0 to 9)
Week 8
3.2
(0 to 9)
3.1
(0 to 9)
Week 12
2.6
(0 to 9)
2.4
(0 to 9)
Week 16
2.5
(0 to 9)
2.6
(0 to 9)
10.Primary Outcome
Title Facial Skin Assessment: Global Acne Assessment
Hide Description 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.
Time Frame 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Effaclar Benzaclin
Hide Arm/Group Description:
Effaclar: Topical, (Benzoyl peroxide 5.5%) Bid, 12 weeks
BenzaClin: Topical, 1% Clindamycin/5% Benzoyl Peroxide, BID, 12 weeks
Overall Number of Participants Analyzed 26 34
Mean (Full Range)
Unit of Measure: score on a scale
Baseline
3.4
(0 to 9)
3.1
(0 to 9)
Week 2
3.1
(0 to 9)
2.7
(0 to 9)
Week 4
2.5
(0 to 9)
2.3
(0 to 9)
Week 8
2.2
(0 to 9)
2.1
(0 to 9)
Week 12
1.7
(0 to 9)
1.7
(0 to 9)
Week 16
2.2
(0 to 9)
2.0
(0 to 9)
11.Primary Outcome
Title Facial Lesion Counts: Open Comedones
Hide Description 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.
Time Frame 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Effaclar Benzaclin
Hide Arm/Group Description:
Effaclar: Topical, (Benzoyl peroxide 5.5%) Bid, 12 weeks
BenzaClin: Topical, 1% Clindamycin/5% Benzoyl Peroxide, BID, 12 weeks
Overall Number of Participants Analyzed 26 34
Mean (Full Range)
Unit of Measure: Open Comedone Count
Baseline
8.4
(1 to 24)
8.3
(1 to 24)
Week 2
5.3
(1 to 12)
4.8
(1 to 12)
Week 4
3.2
(1 to 12)
3.6
(1 to 12)
Week 8
2.9
(1 to 9)
3.5
(1 to 9)
Week 12
1.3
(0 to 5)
0.9
(0 to 5)
Week 16
2.0
(0 to 5)
0.8
(0 to 5)
12.Primary Outcome
Title Facial Lesion Counts: Closed Comedones
Hide Description 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.
Time Frame 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Effaclar Benzaclin
Hide Arm/Group Description:
Effaclar: Topical, (Benzoyl peroxide 5.5%) Bid, 12 weeks
BenzaClin: Topical, 1% Clindamycin/5% Benzoyl Peroxide, BID, 12 weeks
Overall Number of Participants Analyzed 26 34
Mean (Full Range)
Unit of Measure: Closed Comedone Count
Baseline
22.5
(5 to 38)
23
(5 to 38)
Week 2
16.0
(5 to 24)
14.8
(7 to 22)
Week 4
9.8
(1 to 15)
13.7
(1 to 17)
Week 8
8.3
(1 to 21)
9.8
(1 to 14)
Week 12
6.4
(0 to 11)
8.4
(0 to 15)
Week 16
9.4
(0 to 12)
10.0
(0 to 17)
13.Primary Outcome
Title Facial Lesion Counts: Papules
Hide Description 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.
Time Frame 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Effaclar Benzaclin
Hide Arm/Group Description:
Effaclar: Topical, (Benzoyl peroxide 5.5%) Bid, 12 weeks
BenzaClin: Topical, 1% Clindamycin/5% Benzoyl Peroxide, BID, 12 weeks
Overall Number of Participants Analyzed 26 34
Mean (Full Range)
Unit of Measure: Papule Count
Baseline
17.4
(6 to 26)
15.7
(4 to 25)
Week 2
12.0
(2 to 19)
9.0
(3 to 14)
Week 4
8.0
(1 to 16)
6.6
(1 to 10)
Week 8
6.4
(1 to 9)
5.8
(1 to 9)
Week 12
5.3
(1 to 9)
4.0
(1 to 7)
Week 16
6.8
(1 to 11)
4.5
(1 to 7)
14.Primary Outcome
Title Facial Lesion Counts: Pustules
Hide Description 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.
Time Frame 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Effaclar Benzaclin
Hide Arm/Group Description:
Effaclar: Topical, (Benzoyl peroxide 5.5%) Bid, 12 weeks
BenzaClin: Topical, 1% Clindamycin/5% Benzoyl Peroxide, BID, 12 weeks
Overall Number of Participants Analyzed 26 34
Mean (Full Range)
Unit of Measure: Pustules Count
Baseline
3.6
(0 to 8)
3.9
(0 to 8)
Week 2
2.3
(0 to 8)
1.4
(0 to 5)
Week 4
1.4
(0 to 5)
1.3
(0 to 5)
Week 8
0.8
(0 to 4)
0.9
(0 to 4)
Week 12
0.5
(0 to 4)
0.5
(0 to 4)
Week 16
1.0
(0 to 4)
1.7
(0 to 5)
15.Primary Outcome
Title Facial Lesion Counts: Noninflammatory Lesions
Hide Description 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.
Time Frame 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Effaclar Benzaclin
Hide Arm/Group Description:
Effaclar: Topical, (Benzoyl peroxide 5.5%) Bid, 12 weeks
BenzaClin: Topical, 1% Clindamycin/5% Benzoyl Peroxide, BID, 12 weeks
Overall Number of Participants Analyzed 26 34
Mean (Full Range)
Unit of Measure: Noninflammatory Lesion Count
Baseline
30.9
(6 to 61)
31.3
(10 to 65)
Week 2
21.3
(5 to 48)
19.6
(5 to 48)
Week 4
13.0
(2 to 26)
17.3
(4 to 31)
Week 8
11.2
(0 to 17)
13.3
(0 to 20)
Week 12
7.7
(0 to 11)
9.3
(0 to 21)
Week 16
11.4
(0 to 19)
10.9
(0 to 22)
16.Primary Outcome
Title Facial Lesion Counts: Inflammatory Lesions
Hide Description 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.
Time Frame 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Effaclar Benzaclin
Hide Arm/Group Description:
Effaclar: Topical, (Benzoyl peroxide 5.5%) Bid, 12 weeks
BenzaClin: Topical, 1% Clindamycin/5% Benzoyl Peroxide, BID, 12 weeks
Overall Number of Participants Analyzed 26 34
Mean (Full Range)
Unit of Measure: Inflammatory Lesion Count
Baseline
21.0
(6 to 32)
19.6
(5 to 27)
Week 2
14.3
(5 to 22)
10.4
(2 to 14)
Week 4
9.4
(2 to 16)
7.9
(2 to 15)
Week 8
7.2
(0 to 12)
6.7
(0 to 10)
Week 12
5.8
(0 to 8)
4.4
(0 to 6)
Week 16
7.7
(0 to 12)
6.2
(0 to 9)
17.Primary Outcome
Title Facial Lesion Counts: Total Lesion
Hide Description 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.
Time Frame 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Effaclar Benzaclin
Hide Arm/Group Description:
Effaclar: Topical, (Benzoyl peroxide 5.5%) Bid, 12 weeks
BenzaClin: Topical, 1% Clindamycin/5% Benzoyl Peroxide, BID, 12 weeks
Overall Number of Participants Analyzed 26 34
Mean (Full Range)
Unit of Measure: Total Lesion Count
Baseline
51.9
(12 to 66)
51.0
(18 to 72)
Week 2
35.6
(10 to 59)
30.0
(8 to 48)
Week 4
22.5
(10 to 48)
25.1
(13 to 56)
Week 8
18.5
(2 to 31)
20.0
(5 to 25)
Week 12
13.5
(2 to 22)
13.7
(3 to 27)
Week 16
19.0
(5 to 34)
17.0
(2 to 32)
18.Primary Outcome
Title Subjective Tolerability of Irritation Assessment (Participant Assessed): Stinging
Hide Description 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.
Time Frame 16 weeks
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Hide Analysis Population Description
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.
Arm/Group Title Effaclar Benzaclin
Hide Arm/Group Description:
Effaclar: Topical, (Benzoyl peroxide 5.5%) Bid, 12 weeks
BenzaClin: Topical, 1% Clindamycin/5% Benzoyl Peroxide, BID, 12 weeks
Overall Number of Participants Analyzed 26 34
Mean (Full Range)
Unit of Measure: score on a scale
Baseline
0.1
(0 to 3)
0.0
(0 to 3)
Week 2
0.8
(0 to 3)
0.8
(0 to 3)
Week 4
0.4
(0 to 3)
0.4
(0 to 3)
Week 8
0.3
(0 to 3)
0.5
(0 to 3)
Week 12
0.2
(0 to 3)
0.3
(0 to 3)
Week 16
0.1
(0 to 3)
0.2
(0 to 3)
19.Primary Outcome
Title Subjective Tolerability of Irritation Assessment (Participant Assessed): Tingling
Hide Description 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.
Time Frame 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Effaclar Benzaclin
Hide Arm/Group Description:
Effaclar: Topical, (Benzoyl peroxide 5.5%) Bid, 12 weeks
BenzaClin: Topical, 1% Clindamycin/5% Benzoyl Peroxide, BID, 12 weeks
Overall Number of Participants Analyzed 26 34
Mean (Full Range)
Unit of Measure: score on a scale
Baseline
0.1
(0 to 3)
0.0
(0 to 3)
Week 2
0.8
(0 to 3)
0.8
(0 to 3)
Week 4
0.4
(0 to 3)
0.4
(0 to 3)
Week 8
0.3
(0 to 3)
0.5
(0 to 3)
Week 12
0.2
(0 to 3)
0.3
(0 to 3)
Week 16
0.1
(0 to 3)
0.2
(0 to 3)
20.Primary Outcome
Title Subjective Tolerability of Irritation Assessment (Participant Assessed): Itching
Hide Description 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.
Time Frame 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Effaclar Benzaclin
Hide Arm/Group Description:
Effaclar: Topical, (Benzoyl peroxide 5.5%) Bid, 12 weeks
BenzaClin: Topical, 1% Clindamycin/5% Benzoyl Peroxide, BID, 12 weeks
Overall Number of Participants Analyzed 26 34
Mean (Full Range)
Unit of Measure: score on a scale
Baseline
0.2
(0 to 3)
0.1
(0 to 3)
Week 2
0.5
(0 to 3)
0.5
(0 to 3)
Week 4
0.4
(0 to 3)
0.4
(0 to 3)
Week 8
0.3
(0 to 3)
0.3
(0 to 3)
Week 12
0.2
(0 to 3)
0.3
(0 to 3)
Week 16
0.1
(0 to 3)
0.3
(0 to 3)
21.Primary Outcome
Title Subjective Tolerability of Irritation Assessment (Participant Assessed): Burning
Hide Description 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.
Time Frame 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Effaclar Benzaclin
Hide Arm/Group Description:
Effaclar: Topical, (Benzoyl peroxide 5.5%) Bid, 12 weeks
BenzaClin: Topical, 1% Clindamycin/5% Benzoyl Peroxide, BID, 12 weeks
Overall Number of Participants Analyzed 26 34
Mean (Full Range)
Unit of Measure: score on a scale
Baseline
0.2
(0 to 3)
0.1
(0 to 3)
Week 2
1.1
(0 to 3)
1.0
(0 to 3)
Week 4
0.6
(0 to 3)
0.4
(0 to 3)
Week 8
0.5
(0 to 3)
0.5
(0 to 3)
Week 12
0.3
(0 to 3)
0.4
(0 to 3)
Week 16
0.0
(0 to 3)
0.1
(0 to 3)
Time Frame 16 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Effaclar BenzaClin
Hide Arm/Group Description

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

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

All-Cause Mortality
Effaclar BenzaClin
Affected / at Risk (%) Affected / at Risk (%)
Total   0/26 (0.00%)   0/34 (0.00%) 
Hide Serious Adverse Events
Effaclar BenzaClin
Affected / at Risk (%) Affected / at Risk (%)
Total   0/26 (0.00%)   0/34 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Effaclar BenzaClin
Affected / at Risk (%) Affected / at Risk (%)
Total   0/26 (0.00%)   0/34 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Diane Thiboutot
Organization: Penn State Hershey Medical Center
Phone: 717-531-1513
EMail: dthiboutot@pennstatehealth.psu.edu
Layout table for additonal information
Responsible Party: Amy Longenecker, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier: NCT01237821    
Other Study ID Numbers: CS1007033A
First Submitted: November 9, 2010
First Posted: November 10, 2010
Results First Submitted: April 24, 2017
Results First Posted: July 16, 2019
Last Update Posted: July 16, 2019