Comparing OTC Acne Treatment to Prescription Regimen

• Sponsor: Milton S. Hershey Medical Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT01237821
• Collaborator: Loreal USA (Industry)
• Enrollment: 66
• Location: 1
• Arms: 2
• Duration (Months): 12
• Patients Per Site Per Month: 5.5

Study Details

Study Description

Brief Summary

This research is being done to find out the safety and efficacy of two acne creams, Effaclar and Benzaclin when used twice daily with a topical retinoid. Effaclar and Benzaclin are FDA approved for the treatment of acne.

Condition or Disease	Intervention/Treatment	Phase
Acne Vulgaris	Drug: BenzaClin; Drug: Effaclar	N/A

Detailed Description

There are many products on the market to treat facial acne. The medication that this study will be evaluating, Benzaclin and Retin-A have been approved by the FDA and is available by prescription, Effaclar is an over the counter product. This study will hopefully recognize a treatment combination that is effective in reducing acne vulgaris in adults 18-50.

Study Design

• Study Type: Interventional
• Actual Enrollment: 66 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A MULTI-CENTER, DOUBLE-BLIND CLINICAL TRIAL TO EVALUATE THE SAFETY AND EFFICACY OF TWO ACNE CREAMS IN SUBJECTS WITH MILD TO MODERATE ACNE VULGARIS
• Study Start Date: Oct 1, 2010
• Actual Primary Completion Date: Aug 1, 2011
• Actual Study Completion Date: Oct 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: BenzaClin Evaluate and compare tolerance and efficacy of two anti-acne creams, Effaclar and Benzaclin over a twelve week period.Inclusion- males and females ages 18-50, mild to moderate acne vulgaris with > or equal to 15 inflammatory lesions, > or equal to 20 non-inflammatory lesions, avoid excessive sun exposure or tanning beds throughout the study, . Exclusion- Participants who have another skin condition that will interfere with lesion counting or assessments	Drug: BenzaClin; Topical, 1% Clindamycin/5% Benzoyl Peroxide, BID, 12 weeks
Active Comparator: effaclar Evaluate and compare tolerance and efficacy of two anti-acne creams, Effaclar and Benzaclin over a twelve week period.Inclusion- males and females ages 18-50, mild to moderate acne vulgaris with > or equal to 15 inflammatory lesions, > or equal to 20 non-inflammatory lesions, avoid excessive sun exposure or tanning beds throughout the study, . Exclusion- Participants who have another skin condition that will interfere with lesion counting or assessments	Drug: Effaclar; Topical, Bid, 12 weeks

Outcome Measures

Primary Outcome Measures

1. Treatment Tolerability Assessment: Erythema [16 weeks]

   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.

2. Treatment Tolerability Assessment: Edema [16 weeks]

   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.

3. Treatment Tolerability Assessment: Dryness [16 weeks]

   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.

4. Treatment Tolerability Assessment: Peeling [16 weeks]

   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.

5. Facial Skin Assessment: Skin Tone (Clarity) [16 weeks]

   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.

6. Facial Skin Assessment: Skin Smoothness [16 weeks]

   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.

7. Facial Skin Assessment: Skin Brightness [16 weeks]

   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.

8. Facial Skin Assessment: Appearance of Pores [16 weeks]

   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.

9. Facial Skin Assessment: Overall Appearance [16 weeks]

   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.

10. Facial Skin Assessment: Global Acne Assessment [16 weeks]

    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.

11. Facial Lesion Counts: Open Comedones [16 weeks]

    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.

12. Facial Lesion Counts: Closed Comedones [16 weeks]

    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.

13. Facial Lesion Counts: Papules [16 weeks]

    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.

14. Facial Lesion Counts: Pustules [16 weeks]

    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.

15. Facial Lesion Counts: Noninflammatory Lesions [16 weeks]

    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.

16. Facial Lesion Counts: Inflammatory Lesions [16 weeks]

    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.

17. Facial Lesion Counts: Total Lesion [16 weeks]

    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.

18. Subjective Tolerability of Irritation Assessment (Participant Assessed): Stinging [16 weeks]

    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.

19. Subjective Tolerability of Irritation Assessment (Participant Assessed): Tingling [16 weeks]

    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.

20. Subjective Tolerability of Irritation Assessment (Participant Assessed): Itching [16 weeks]

    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.

21. Subjective Tolerability of Irritation Assessment (Participant Assessed): Burning [16 weeks]

    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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 50 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:males and females ages 18-50, mild to moderate acne vulgaris with > or equal to 15 inflammatory lesions, > or equal to 20 non-inflammatory lesions, avoid excessive sun exposure or tanning beds throughout the study

Exclusion Criteria:Participants who have another skin condition that will interfere with lesion counting or assessments

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Penn State Hershey Medical Center	Hershey	Pennsylvania	United States	17033

Sponsors and Collaborators

• Milton S. Hershey Medical Center
• Loreal USA

Investigators

• Study Director: Christian Oresajo, PhD, Loreal USA

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Amy Longenecker, RN, CCRC, Milton S. Hershey Medical Center
• ClinicalTrials.gov Identifier: NCT01237821
• Other Study ID Numbers: CS1007033A
• First Posted: Nov 10, 2010
• Last Update Posted: Jul 16, 2019
• Last Verified: Jun 1, 2019

• Additional relevant MeSH terms: Acne Vulgaris

Study Results

Participant Flow

Arm/Group Title	BenzaClin	Effaclar
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

Baseline Characteristics

Arm/Group Title	BenzaClin	Effaclar	Total
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 Participants	26	34	60
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	26 100%	34 100%	60 100%
>=65 years	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	29.53 (9.81)	32.41 (9.30)	30.92 (9.60)
Sex: Female, Male (Count of Participants)
Female	20 76.9%	28 82.4%	48 80%
Male	6 23.1%	6 17.6%	12 20%
Region of Enrollment (participants) [Number]
United States	26 100%	34 100%	66 110%

Outcome Measures

1. Primary Outcome

Title	Treatment Tolerability Assessment: Erythema
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

Outcome Measure Data

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
Arm/Group Description	Effaclar: Topical, (Benzoyl peroxide 5.5%) Bid, 12 weeks	BenzaClin: Topical, 1% Clindamycin/5% Benzoyl Peroxide, BID, 12 weeks
Measure Participants	26	34
Baseline	0.3	0.4
Week 2	0.6	0.4
Week 4	0.3	0.4
Week 8	0.1	0.2
Week 12	0.2	0.2
Week 16	0.1	0.1

2. Primary Outcome

Title	Treatment Tolerability Assessment: Edema
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

Outcome Measure Data

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
Arm/Group Description	Effaclar: Topical, (Benzoyl peroxide 5.5%) Bid, 12 weeks	BenzaClin: Topical, 1% Clindamycin/5% Benzoyl Peroxide, BID, 12 weeks
Measure Participants	26	34
Baseline	0.1	0.1
Week 2	0.2	0.2
Week 4	0.1	0.2
Week 8	0.0	0.1
Week 12	0.0	0.0
Week 16	0.0	0.0

3. Primary Outcome

Title	Treatment Tolerability Assessment: Dryness
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

Outcome Measure Data

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
Arm/Group Description	Effaclar: Topical, (Benzoyl peroxide 5.5%) Bid, 12 weeks	BenzaClin: Topical, 1% Clindamycin/5% Benzoyl Peroxide, BID, 12 weeks
Measure Participants	26	34
Baseline	0.4	0.2
Week 2	0.9	0.7
Week 4	0.6	0.3
Week 8	0.2	0.2
Week 12	0.2	0.2
Week 16	0.0	0.0

4. Primary Outcome

Title	Treatment Tolerability Assessment: Peeling
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

Outcome Measure Data

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
Arm/Group Description	Effaclar: Topical, (Benzoyl peroxide 5.5%) Bid, 12 weeks	BenzaClin: Topical, 1% Clindamycin/5% Benzoyl Peroxide, BID, 12 weeks
Measure Participants	26	34
Baseline	0.1	0.0
Week 2	0.5	0.6
Week 4	0.5	0.3
Week 8	0.1	0.2
Week 12	0.1	0.1
Week 16	0.0	0.0

5. Primary Outcome

Title	Facial Skin Assessment: Skin Tone (Clarity)
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

Outcome Measure Data

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
Arm/Group Description	Effaclar: Topical, (Benzoyl peroxide 5.5%) Bid, 12 weeks	BenzaClin: Topical, 1% Clindamycin/5% Benzoyl Peroxide, BID, 12 weeks
Measure Participants	26	34
Baseline	5.3	5.0
Week 2	4.6	4.4
Week 4	4.1	3.9
Week 8	3.3	3.2
Week 12	2.6	2.3
Week 16	2.7	2.7

6. Primary Outcome

Title	Facial Skin Assessment: Skin Smoothness
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

Outcome Measure Data

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
Arm/Group Description	Effaclar: Topical, (Benzoyl peroxide 5.5%) Bid, 12 weeks	BenzaClin: Topical, 1% Clindamycin/5% Benzoyl Peroxide, BID, 12 weeks
Measure Participants	26	34
Baseline	5.0	4.9
Week 2	4.7	4.5
Week 4	4.2	3.5
Week 8	3.2	2.7
Week 12	2.3	2.1
Week 16	2.2	2.3

7. Primary Outcome

Title	Facial Skin Assessment: Skin Brightness
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

Outcome Measure Data

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
Arm/Group Description	Effaclar: Topical, (Benzoyl peroxide 5.5%) Bid, 12 weeks	BenzaClin: Topical, 1% Clindamycin/5% Benzoyl Peroxide, BID, 12 weeks
Measure Participants	26	34
Baseline	5.1	4.6
Week 2	4.6	4.1
Week 4	4.0	3.6
Week 8	3.2	2.8
Week 12	2.5	2.4
Week 16	2.6	2.6

8. Primary Outcome

Title	Facial Skin Assessment: Appearance of Pores
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

Outcome Measure Data

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
Arm/Group Description	Effaclar: Topical, (Benzoyl peroxide 5.5%) Bid, 12 weeks	BenzaClin: Topical, 1% Clindamycin/5% Benzoyl Peroxide, BID, 12 weeks
Measure Participants	26	34
Baseline	4.6	4.6
Week 2	4.3	4.5
Week 4	4.1	4.2
Week 8	3.5	3.6
Week 12	3.2	3.1
Week 16	3.1	3.3

9. Primary Outcome

Title	Facial Skin Assessment: Overall Appearance
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

Outcome Measure Data

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
Arm/Group Description	Effaclar: Topical, (Benzoyl peroxide 5.5%) Bid, 12 weeks	BenzaClin: Topical, 1% Clindamycin/5% Benzoyl Peroxide, BID, 12 weeks
Measure Participants	26	34
Baseline	5.1	5.0
Week 2	4.7	4.4
Week 4	4.3	3.9
Week 8	3.2	3.1
Week 12	2.6	2.4
Week 16	2.5	2.6

10. Primary Outcome

Title	Facial Skin Assessment: Global Acne Assessment
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

Outcome Measure Data

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
Arm/Group Description	Effaclar: Topical, (Benzoyl peroxide 5.5%) Bid, 12 weeks	BenzaClin: Topical, 1% Clindamycin/5% Benzoyl Peroxide, BID, 12 weeks
Measure Participants	26	34
Baseline	3.4	3.1
Week 2	3.1	2.7
Week 4	2.5	2.3
Week 8	2.2	2.1
Week 12	1.7	1.7
Week 16	2.2	2.0

11. Primary Outcome

Title	Facial Lesion Counts: Open Comedones
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

Outcome Measure Data

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
Arm/Group Description	Effaclar: Topical, (Benzoyl peroxide 5.5%) Bid, 12 weeks	BenzaClin: Topical, 1% Clindamycin/5% Benzoyl Peroxide, BID, 12 weeks
Measure Participants	26	34
Baseline	8.4	8.3
Week 2	5.3	4.8
Week 4	3.2	3.6
Week 8	2.9	3.5
Week 12	1.3	0.9
Week 16	2.0	0.8

12. Primary Outcome

Title	Facial Lesion Counts: Closed Comedones
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

Outcome Measure Data

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
Arm/Group Description	Effaclar: Topical, (Benzoyl peroxide 5.5%) Bid, 12 weeks	BenzaClin: Topical, 1% Clindamycin/5% Benzoyl Peroxide, BID, 12 weeks
Measure Participants	26	34
Baseline	22.5	23
Week 2	16.0	14.8
Week 4	9.8	13.7
Week 8	8.3	9.8
Week 12	6.4	8.4
Week 16	9.4	10.0

13. Primary Outcome

Title	Facial Lesion Counts: Papules
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

Outcome Measure Data

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
Arm/Group Description	Effaclar: Topical, (Benzoyl peroxide 5.5%) Bid, 12 weeks	BenzaClin: Topical, 1% Clindamycin/5% Benzoyl Peroxide, BID, 12 weeks
Measure Participants	26	34
Baseline	17.4	15.7
Week 2	12.0	9.0
Week 4	8.0	6.6
Week 8	6.4	5.8
Week 12	5.3	4.0
Week 16	6.8	4.5

14. Primary Outcome

Title	Facial Lesion Counts: Pustules
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

Outcome Measure Data

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
Arm/Group Description	Effaclar: Topical, (Benzoyl peroxide 5.5%) Bid, 12 weeks	BenzaClin: Topical, 1% Clindamycin/5% Benzoyl Peroxide, BID, 12 weeks
Measure Participants	26	34
Baseline	3.6	3.9
Week 2	2.3	1.4
Week 4	1.4	1.3
Week 8	0.8	0.9
Week 12	0.5	0.5
Week 16	1.0	1.7

15. Primary Outcome

Title	Facial Lesion Counts: Noninflammatory Lesions
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

Outcome Measure Data

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
Arm/Group Description	Effaclar: Topical, (Benzoyl peroxide 5.5%) Bid, 12 weeks	BenzaClin: Topical, 1% Clindamycin/5% Benzoyl Peroxide, BID, 12 weeks
Measure Participants	26	34
Baseline	30.9	31.3
Week 2	21.3	19.6
Week 4	13.0	17.3
Week 8	11.2	13.3
Week 12	7.7	9.3
Week 16	11.4	10.9

16. Primary Outcome

Title	Facial Lesion Counts: Inflammatory Lesions
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

Outcome Measure Data

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
Arm/Group Description	Effaclar: Topical, (Benzoyl peroxide 5.5%) Bid, 12 weeks	BenzaClin: Topical, 1% Clindamycin/5% Benzoyl Peroxide, BID, 12 weeks
Measure Participants	26	34
Baseline	21.0	19.6
Week 2	14.3	10.4
Week 4	9.4	7.9
Week 8	7.2	6.7
Week 12	5.8	4.4
Week 16	7.7	6.2

17. Primary Outcome

Title	Facial Lesion Counts: Total Lesion
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

Outcome Measure Data

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
Arm/Group Description	Effaclar: Topical, (Benzoyl peroxide 5.5%) Bid, 12 weeks	BenzaClin: Topical, 1% Clindamycin/5% Benzoyl Peroxide, BID, 12 weeks
Measure Participants	26	34
Baseline	51.9	51.0
Week 2	35.6	30.0
Week 4	22.5	25.1
Week 8	18.5	20.0
Week 12	13.5	13.7
Week 16	19.0	17.0

18. Primary Outcome

Title	Subjective Tolerability of Irritation Assessment (Participant Assessed): Stinging
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

Outcome Measure Data

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
Arm/Group Description	Effaclar: Topical, (Benzoyl peroxide 5.5%) Bid, 12 weeks	BenzaClin: Topical, 1% Clindamycin/5% Benzoyl Peroxide, BID, 12 weeks
Measure Participants	26	34
Baseline	0.1	0.0
Week 2	0.8	0.8
Week 4	0.4	0.4
Week 8	0.3	0.5
Week 12	0.2	0.3
Week 16	0.1	0.2

19. Primary Outcome

Title	Subjective Tolerability of Irritation Assessment (Participant Assessed): Tingling
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

Outcome Measure Data

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
Arm/Group Description	Effaclar: Topical, (Benzoyl peroxide 5.5%) Bid, 12 weeks	BenzaClin: Topical, 1% Clindamycin/5% Benzoyl Peroxide, BID, 12 weeks
Measure Participants	26	34
Baseline	0.1	0.0
Week 2	0.8	0.8
Week 4	0.4	0.4
Week 8	0.3	0.5
Week 12	0.2	0.3
Week 16	0.1	0.2

20. Primary Outcome

Title	Subjective Tolerability of Irritation Assessment (Participant Assessed): Itching
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

Outcome Measure Data

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
Arm/Group Description	Effaclar: Topical, (Benzoyl peroxide 5.5%) Bid, 12 weeks	BenzaClin: Topical, 1% Clindamycin/5% Benzoyl Peroxide, BID, 12 weeks
Measure Participants	26	34
Baseline	0.2	0.1
Week 2	0.5	0.5
Week 4	0.4	0.4
Week 8	0.3	0.3
Week 12	0.2	0.3
Week 16	0.1	0.3

21. Primary Outcome

Title	Subjective Tolerability of Irritation Assessment (Participant Assessed): Burning
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

Outcome Measure Data

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
Arm/Group Description	Effaclar: Topical, (Benzoyl peroxide 5.5%) Bid, 12 weeks	BenzaClin: Topical, 1% Clindamycin/5% Benzoyl Peroxide, BID, 12 weeks
Measure Participants	26	34
Baseline	0.2	0.1
Week 2	1.1	1.0
Week 4	0.6	0.4
Week 8	0.5	0.5
Week 12	0.3	0.4
Week 16	0.0	0.1

Adverse Events

Time Frame	16 weeks
Arm/Group Title	Effaclar		BenzaClin
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 (%)	# Events	Affected / at Risk (%)	# Events
Total	0/26 (0%)		0/34 (0%)
Serious Adverse Events
	Effaclar		BenzaClin
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/26 (0%)		0/34 (0%)
Other (Not Including Serious) Adverse Events
	Effaclar		BenzaClin
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/26 (0%)		0/34 (0%)

Limitations/Caveats

[Not Specified]

More Information

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.