Acne Vulgaris
Conditions
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.
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.
Interventions
DRUGBenzaClin
Topical, 1% Clindamycin/5% Benzoyl Peroxide, BID, 12 weeks
DRUGEffaclar
Topical, Bid, 12 weeks
Sponsors
Loreal USA
Milton S. Hershey Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 26 |
| 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 | 34 |
| Total | 60 |
Baseline characteristics
| Characteristic | Total | BenzaClin | Effaclar |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 60 Participants | 26 Participants | 34 Participants |
| Age, Continuous | 30.92 years STANDARD_DEVIATION 9.6 | 29.53 years STANDARD_DEVIATION 9.81 | 32.41 years STANDARD_DEVIATION 9.3 |
| Region of Enrollment United States | 66 participants | 26 participants | 34 participants |
| Sex: Female, Male Female | 48 Participants | 20 Participants | 28 Participants |
| Sex: Female, Male Male | 12 Participants | 6 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 26 | 0 / 34 |
| other Total, other adverse events | 0 / 26 | 0 / 34 |
| serious Total, serious adverse events | 0 / 26 | 0 / 34 |
Outcome results
Primary
Facial Lesion Counts: Closed Comedones
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
Population: 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 | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Effaclar | Facial Lesion Counts: Closed Comedones | Baseline | 22.5 Closed Comedone Count |
| Effaclar | Facial Lesion Counts: Closed Comedones | Week 2 | 16.0 Closed Comedone Count |
| Effaclar | Facial Lesion Counts: Closed Comedones | Week 4 | 9.8 Closed Comedone Count |
| Effaclar | Facial Lesion Counts: Closed Comedones | Week 8 | 8.3 Closed Comedone Count |
| Effaclar | Facial Lesion Counts: Closed Comedones | Week 12 | 6.4 Closed Comedone Count |
| Effaclar | Facial Lesion Counts: Closed Comedones | Week 16 | 9.4 Closed Comedone Count |
| Benzaclin | Facial Lesion Counts: Closed Comedones | Week 12 | 8.4 Closed Comedone Count |
| Benzaclin | Facial Lesion Counts: Closed Comedones | Baseline | 23 Closed Comedone Count |
| Benzaclin | Facial Lesion Counts: Closed Comedones | Week 8 | 9.8 Closed Comedone Count |
| Benzaclin | Facial Lesion Counts: Closed Comedones | Week 2 | 14.8 Closed Comedone Count |
| Benzaclin | Facial Lesion Counts: Closed Comedones | Week 16 | 10.0 Closed Comedone Count |
| Benzaclin | Facial Lesion Counts: Closed Comedones | Week 4 | 13.7 Closed Comedone Count |
Primary
Facial Lesion Counts: Inflammatory Lesions
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
Population: 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 | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Effaclar | Facial Lesion Counts: Inflammatory Lesions | Baseline | 21.0 Inflammatory Lesion Count |
| Effaclar | Facial Lesion Counts: Inflammatory Lesions | Week 2 | 14.3 Inflammatory Lesion Count |
| Effaclar | Facial Lesion Counts: Inflammatory Lesions | Week 4 | 9.4 Inflammatory Lesion Count |
| Effaclar | Facial Lesion Counts: Inflammatory Lesions | Week 8 | 7.2 Inflammatory Lesion Count |
| Effaclar | Facial Lesion Counts: Inflammatory Lesions | Week 12 | 5.8 Inflammatory Lesion Count |
| Effaclar | Facial Lesion Counts: Inflammatory Lesions | Week 16 | 7.7 Inflammatory Lesion Count |
| Benzaclin | Facial Lesion Counts: Inflammatory Lesions | Week 12 | 4.4 Inflammatory Lesion Count |
| Benzaclin | Facial Lesion Counts: Inflammatory Lesions | Baseline | 19.6 Inflammatory Lesion Count |
| Benzaclin | Facial Lesion Counts: Inflammatory Lesions | Week 8 | 6.7 Inflammatory Lesion Count |
| Benzaclin | Facial Lesion Counts: Inflammatory Lesions | Week 2 | 10.4 Inflammatory Lesion Count |
| Benzaclin | Facial Lesion Counts: Inflammatory Lesions | Week 16 | 6.2 Inflammatory Lesion Count |
| Benzaclin | Facial Lesion Counts: Inflammatory Lesions | Week 4 | 7.9 Inflammatory Lesion Count |
Primary
Facial Lesion Counts: Noninflammatory Lesions
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
Population: 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 | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Effaclar | Facial Lesion Counts: Noninflammatory Lesions | Baseline | 30.9 Noninflammatory Lesion Count |
| Effaclar | Facial Lesion Counts: Noninflammatory Lesions | Week 2 | 21.3 Noninflammatory Lesion Count |
| Effaclar | Facial Lesion Counts: Noninflammatory Lesions | Week 4 | 13.0 Noninflammatory Lesion Count |
| Effaclar | Facial Lesion Counts: Noninflammatory Lesions | Week 8 | 11.2 Noninflammatory Lesion Count |
| Effaclar | Facial Lesion Counts: Noninflammatory Lesions | Week 12 | 7.7 Noninflammatory Lesion Count |
| Effaclar | Facial Lesion Counts: Noninflammatory Lesions | Week 16 | 11.4 Noninflammatory Lesion Count |
| Benzaclin | Facial Lesion Counts: Noninflammatory Lesions | Week 12 | 9.3 Noninflammatory Lesion Count |
| Benzaclin | Facial Lesion Counts: Noninflammatory Lesions | Baseline | 31.3 Noninflammatory Lesion Count |
| Benzaclin | Facial Lesion Counts: Noninflammatory Lesions | Week 8 | 13.3 Noninflammatory Lesion Count |
| Benzaclin | Facial Lesion Counts: Noninflammatory Lesions | Week 2 | 19.6 Noninflammatory Lesion Count |
| Benzaclin | Facial Lesion Counts: Noninflammatory Lesions | Week 16 | 10.9 Noninflammatory Lesion Count |
| Benzaclin | Facial Lesion Counts: Noninflammatory Lesions | Week 4 | 17.3 Noninflammatory Lesion Count |
Primary
Facial Lesion Counts: Open Comedones
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
Population: 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 | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Effaclar | Facial Lesion Counts: Open Comedones | Baseline | 8.4 Open Comedone Count |
| Effaclar | Facial Lesion Counts: Open Comedones | Week 2 | 5.3 Open Comedone Count |
| Effaclar | Facial Lesion Counts: Open Comedones | Week 4 | 3.2 Open Comedone Count |
| Effaclar | Facial Lesion Counts: Open Comedones | Week 8 | 2.9 Open Comedone Count |
| Effaclar | Facial Lesion Counts: Open Comedones | Week 12 | 1.3 Open Comedone Count |
| Effaclar | Facial Lesion Counts: Open Comedones | Week 16 | 2.0 Open Comedone Count |
| Benzaclin | Facial Lesion Counts: Open Comedones | Week 12 | 0.9 Open Comedone Count |
| Benzaclin | Facial Lesion Counts: Open Comedones | Baseline | 8.3 Open Comedone Count |
| Benzaclin | Facial Lesion Counts: Open Comedones | Week 8 | 3.5 Open Comedone Count |
| Benzaclin | Facial Lesion Counts: Open Comedones | Week 2 | 4.8 Open Comedone Count |
| Benzaclin | Facial Lesion Counts: Open Comedones | Week 16 | 0.8 Open Comedone Count |
| Benzaclin | Facial Lesion Counts: Open Comedones | Week 4 | 3.6 Open Comedone Count |
Primary
Facial Lesion Counts: Papules
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
Population: 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 | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Effaclar | Facial Lesion Counts: Papules | Baseline | 17.4 Papule Count |
| Effaclar | Facial Lesion Counts: Papules | Week 2 | 12.0 Papule Count |
| Effaclar | Facial Lesion Counts: Papules | Week 4 | 8.0 Papule Count |
| Effaclar | Facial Lesion Counts: Papules | Week 8 | 6.4 Papule Count |
| Effaclar | Facial Lesion Counts: Papules | Week 12 | 5.3 Papule Count |
| Effaclar | Facial Lesion Counts: Papules | Week 16 | 6.8 Papule Count |
| Benzaclin | Facial Lesion Counts: Papules | Week 12 | 4.0 Papule Count |
| Benzaclin | Facial Lesion Counts: Papules | Baseline | 15.7 Papule Count |
| Benzaclin | Facial Lesion Counts: Papules | Week 8 | 5.8 Papule Count |
| Benzaclin | Facial Lesion Counts: Papules | Week 2 | 9.0 Papule Count |
| Benzaclin | Facial Lesion Counts: Papules | Week 16 | 4.5 Papule Count |
| Benzaclin | Facial Lesion Counts: Papules | Week 4 | 6.6 Papule Count |
Primary
Facial Lesion Counts: Pustules
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
Population: 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 | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Effaclar | Facial Lesion Counts: Pustules | Week 12 | 0.5 Pustules Count |
| Effaclar | Facial Lesion Counts: Pustules | Week 16 | 1.0 Pustules Count |
| Effaclar | Facial Lesion Counts: Pustules | Baseline | 3.6 Pustules Count |
| Effaclar | Facial Lesion Counts: Pustules | Week 2 | 2.3 Pustules Count |
| Effaclar | Facial Lesion Counts: Pustules | Week 4 | 1.4 Pustules Count |
| Effaclar | Facial Lesion Counts: Pustules | Week 8 | 0.8 Pustules Count |
| Benzaclin | Facial Lesion Counts: Pustules | Week 4 | 1.3 Pustules Count |
| Benzaclin | Facial Lesion Counts: Pustules | Week 12 | 0.5 Pustules Count |
| Benzaclin | Facial Lesion Counts: Pustules | Week 2 | 1.4 Pustules Count |
| Benzaclin | Facial Lesion Counts: Pustules | Week 16 | 1.7 Pustules Count |
| Benzaclin | Facial Lesion Counts: Pustules | Week 8 | 0.9 Pustules Count |
| Benzaclin | Facial Lesion Counts: Pustules | Baseline | 3.9 Pustules Count |
Primary
Facial Lesion Counts: Total Lesion
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
Population: 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 | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Effaclar | Facial Lesion Counts: Total Lesion | Baseline | 51.9 Total Lesion Count |
| Effaclar | Facial Lesion Counts: Total Lesion | Week 8 | 18.5 Total Lesion Count |
| Effaclar | Facial Lesion Counts: Total Lesion | Week 16 | 19.0 Total Lesion Count |
| Effaclar | Facial Lesion Counts: Total Lesion | Week 12 | 13.5 Total Lesion Count |
| Effaclar | Facial Lesion Counts: Total Lesion | Week 2 | 35.6 Total Lesion Count |
| Effaclar | Facial Lesion Counts: Total Lesion | Week 4 | 22.5 Total Lesion Count |
| Benzaclin | Facial Lesion Counts: Total Lesion | Week 16 | 17.0 Total Lesion Count |
| Benzaclin | Facial Lesion Counts: Total Lesion | Baseline | 51.0 Total Lesion Count |
| Benzaclin | Facial Lesion Counts: Total Lesion | Week 4 | 25.1 Total Lesion Count |
| Benzaclin | Facial Lesion Counts: Total Lesion | Week 8 | 20.0 Total Lesion Count |
| Benzaclin | Facial Lesion Counts: Total Lesion | Week 12 | 13.7 Total Lesion Count |
| Benzaclin | Facial Lesion Counts: Total Lesion | Week 2 | 30.0 Total Lesion Count |
Primary
Facial Skin Assessment: Appearance of Pores
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
Population: 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 | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Effaclar | Facial Skin Assessment: Appearance of Pores | Baseline | 4.6 score on a scale |
| Effaclar | Facial Skin Assessment: Appearance of Pores | Week 2 | 4.3 score on a scale |
| Effaclar | Facial Skin Assessment: Appearance of Pores | Week 4 | 4.1 score on a scale |
| Effaclar | Facial Skin Assessment: Appearance of Pores | Week 8 | 3.5 score on a scale |
| Effaclar | Facial Skin Assessment: Appearance of Pores | Week 12 | 3.2 score on a scale |
| Effaclar | Facial Skin Assessment: Appearance of Pores | Week 16 | 3.1 score on a scale |
| Benzaclin | Facial Skin Assessment: Appearance of Pores | Week 12 | 3.1 score on a scale |
| Benzaclin | Facial Skin Assessment: Appearance of Pores | Baseline | 4.6 score on a scale |
| Benzaclin | Facial Skin Assessment: Appearance of Pores | Week 8 | 3.6 score on a scale |
| Benzaclin | Facial Skin Assessment: Appearance of Pores | Week 2 | 4.5 score on a scale |
| Benzaclin | Facial Skin Assessment: Appearance of Pores | Week 16 | 3.3 score on a scale |
| Benzaclin | Facial Skin Assessment: Appearance of Pores | Week 4 | 4.2 score on a scale |
Primary
Facial Skin Assessment: Global Acne Assessment
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
Population: 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 | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Effaclar | Facial Skin Assessment: Global Acne Assessment | Week 8 | 2.2 score on a scale |
| Effaclar | Facial Skin Assessment: Global Acne Assessment | Week 12 | 1.7 score on a scale |
| Effaclar | Facial Skin Assessment: Global Acne Assessment | Week 4 | 2.5 score on a scale |
| Effaclar | Facial Skin Assessment: Global Acne Assessment | Week 16 | 2.2 score on a scale |
| Effaclar | Facial Skin Assessment: Global Acne Assessment | Baseline | 3.4 score on a scale |
| Effaclar | Facial Skin Assessment: Global Acne Assessment | Week 2 | 3.1 score on a scale |
| Benzaclin | Facial Skin Assessment: Global Acne Assessment | Baseline | 3.1 score on a scale |
| Benzaclin | Facial Skin Assessment: Global Acne Assessment | Week 8 | 2.1 score on a scale |
| Benzaclin | Facial Skin Assessment: Global Acne Assessment | Week 16 | 2.0 score on a scale |
| Benzaclin | Facial Skin Assessment: Global Acne Assessment | Week 2 | 2.7 score on a scale |
| Benzaclin | Facial Skin Assessment: Global Acne Assessment | Week 4 | 2.3 score on a scale |
| Benzaclin | Facial Skin Assessment: Global Acne Assessment | Week 12 | 1.7 score on a scale |
Primary
Facial Skin Assessment: Overall Appearance
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
Population: 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 | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Effaclar | Facial Skin Assessment: Overall Appearance | Baseline | 5.1 score on a scale |
| Effaclar | Facial Skin Assessment: Overall Appearance | Week 2 | 4.7 score on a scale |
| Effaclar | Facial Skin Assessment: Overall Appearance | Week 4 | 4.3 score on a scale |
| Effaclar | Facial Skin Assessment: Overall Appearance | Week 8 | 3.2 score on a scale |
| Effaclar | Facial Skin Assessment: Overall Appearance | Week 12 | 2.6 score on a scale |
| Effaclar | Facial Skin Assessment: Overall Appearance | Week 16 | 2.5 score on a scale |
| Benzaclin | Facial Skin Assessment: Overall Appearance | Week 12 | 2.4 score on a scale |
| Benzaclin | Facial Skin Assessment: Overall Appearance | Baseline | 5.0 score on a scale |
| Benzaclin | Facial Skin Assessment: Overall Appearance | Week 8 | 3.1 score on a scale |
| Benzaclin | Facial Skin Assessment: Overall Appearance | Week 2 | 4.4 score on a scale |
| Benzaclin | Facial Skin Assessment: Overall Appearance | Week 16 | 2.6 score on a scale |
| Benzaclin | Facial Skin Assessment: Overall Appearance | Week 4 | 3.9 score on a scale |
Primary
Facial Skin Assessment: Skin Brightness
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
Population: 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 | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Effaclar | Facial Skin Assessment: Skin Brightness | Baseline | 5.1 score on a scale |
| Effaclar | Facial Skin Assessment: Skin Brightness | Week 2 | 4.6 score on a scale |
| Effaclar | Facial Skin Assessment: Skin Brightness | Week 4 | 4.0 score on a scale |
| Effaclar | Facial Skin Assessment: Skin Brightness | Week 8 | 3.2 score on a scale |
| Effaclar | Facial Skin Assessment: Skin Brightness | Week 12 | 2.5 score on a scale |
| Effaclar | Facial Skin Assessment: Skin Brightness | Week 16 | 2.6 score on a scale |
| Benzaclin | Facial Skin Assessment: Skin Brightness | Week 12 | 2.4 score on a scale |
| Benzaclin | Facial Skin Assessment: Skin Brightness | Baseline | 4.6 score on a scale |
| Benzaclin | Facial Skin Assessment: Skin Brightness | Week 8 | 2.8 score on a scale |
| Benzaclin | Facial Skin Assessment: Skin Brightness | Week 2 | 4.1 score on a scale |
| Benzaclin | Facial Skin Assessment: Skin Brightness | Week 16 | 2.6 score on a scale |
| Benzaclin | Facial Skin Assessment: Skin Brightness | Week 4 | 3.6 score on a scale |
Primary
Facial Skin Assessment: Skin Smoothness
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
Population: 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 | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Effaclar | Facial Skin Assessment: Skin Smoothness | Baseline | 5.0 score on a scale |
| Effaclar | Facial Skin Assessment: Skin Smoothness | Week 2 | 4.7 score on a scale |
| Effaclar | Facial Skin Assessment: Skin Smoothness | Week 4 | 4.2 score on a scale |
| Effaclar | Facial Skin Assessment: Skin Smoothness | Week 8 | 3.2 score on a scale |
| Effaclar | Facial Skin Assessment: Skin Smoothness | Week 12 | 2.3 score on a scale |
| Effaclar | Facial Skin Assessment: Skin Smoothness | Week 16 | 2.2 score on a scale |
| Benzaclin | Facial Skin Assessment: Skin Smoothness | Week 12 | 2.1 score on a scale |
| Benzaclin | Facial Skin Assessment: Skin Smoothness | Baseline | 4.9 score on a scale |
| Benzaclin | Facial Skin Assessment: Skin Smoothness | Week 8 | 2.7 score on a scale |
| Benzaclin | Facial Skin Assessment: Skin Smoothness | Week 2 | 4.5 score on a scale |
| Benzaclin | Facial Skin Assessment: Skin Smoothness | Week 16 | 2.3 score on a scale |
| Benzaclin | Facial Skin Assessment: Skin Smoothness | Week 4 | 3.5 score on a scale |
Primary
Facial Skin Assessment: Skin Tone (Clarity)
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
Population: 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 | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Effaclar | Facial Skin Assessment: Skin Tone (Clarity) | Baseline | 5.3 score on a scale |
| Effaclar | Facial Skin Assessment: Skin Tone (Clarity) | Week 2 | 4.6 score on a scale |
| Effaclar | Facial Skin Assessment: Skin Tone (Clarity) | Week 4 | 4.1 score on a scale |
| Effaclar | Facial Skin Assessment: Skin Tone (Clarity) | Week 8 | 3.3 score on a scale |
| Effaclar | Facial Skin Assessment: Skin Tone (Clarity) | Week 12 | 2.6 score on a scale |
| Effaclar | Facial Skin Assessment: Skin Tone (Clarity) | Week 16 | 2.7 score on a scale |
| Benzaclin | Facial Skin Assessment: Skin Tone (Clarity) | Week 12 | 2.3 score on a scale |
| Benzaclin | Facial Skin Assessment: Skin Tone (Clarity) | Baseline | 5.0 score on a scale |
| Benzaclin | Facial Skin Assessment: Skin Tone (Clarity) | Week 8 | 3.2 score on a scale |
| Benzaclin | Facial Skin Assessment: Skin Tone (Clarity) | Week 2 | 4.4 score on a scale |
| Benzaclin | Facial Skin Assessment: Skin Tone (Clarity) | Week 16 | 2.7 score on a scale |
| Benzaclin | Facial Skin Assessment: Skin Tone (Clarity) | Week 4 | 3.9 score on a scale |
Primary
Subjective Tolerability of Irritation Assessment (Participant Assessed): Burning
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
Population: 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 | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Effaclar | Subjective Tolerability of Irritation Assessment (Participant Assessed): Burning | Baseline | 0.2 score on a scale |
| Effaclar | Subjective Tolerability of Irritation Assessment (Participant Assessed): Burning | Week 2 | 1.1 score on a scale |
| Effaclar | Subjective Tolerability of Irritation Assessment (Participant Assessed): Burning | Week 4 | 0.6 score on a scale |
| Effaclar | Subjective Tolerability of Irritation Assessment (Participant Assessed): Burning | Week 8 | 0.5 score on a scale |
| Effaclar | Subjective Tolerability of Irritation Assessment (Participant Assessed): Burning | Week 12 | 0.3 score on a scale |
| Effaclar | Subjective Tolerability of Irritation Assessment (Participant Assessed): Burning | Week 16 | 0.0 score on a scale |
| Benzaclin | Subjective Tolerability of Irritation Assessment (Participant Assessed): Burning | Week 12 | 0.4 score on a scale |
| Benzaclin | Subjective Tolerability of Irritation Assessment (Participant Assessed): Burning | Baseline | 0.1 score on a scale |
| Benzaclin | Subjective Tolerability of Irritation Assessment (Participant Assessed): Burning | Week 8 | 0.5 score on a scale |
| Benzaclin | Subjective Tolerability of Irritation Assessment (Participant Assessed): Burning | Week 2 | 1.0 score on a scale |
| Benzaclin | Subjective Tolerability of Irritation Assessment (Participant Assessed): Burning | Week 16 | 0.1 score on a scale |
| Benzaclin | Subjective Tolerability of Irritation Assessment (Participant Assessed): Burning | Week 4 | 0.4 score on a scale |
Primary
Subjective Tolerability of Irritation Assessment (Participant Assessed): Itching
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
Population: 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 | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Effaclar | Subjective Tolerability of Irritation Assessment (Participant Assessed): Itching | Baseline | 0.2 score on a scale |
| Effaclar | Subjective Tolerability of Irritation Assessment (Participant Assessed): Itching | Week 2 | 0.5 score on a scale |
| Effaclar | Subjective Tolerability of Irritation Assessment (Participant Assessed): Itching | Week 4 | 0.4 score on a scale |
| Effaclar | Subjective Tolerability of Irritation Assessment (Participant Assessed): Itching | Week 8 | 0.3 score on a scale |
| Effaclar | Subjective Tolerability of Irritation Assessment (Participant Assessed): Itching | Week 12 | 0.2 score on a scale |
| Effaclar | Subjective Tolerability of Irritation Assessment (Participant Assessed): Itching | Week 16 | 0.1 score on a scale |
| Benzaclin | Subjective Tolerability of Irritation Assessment (Participant Assessed): Itching | Week 12 | 0.3 score on a scale |
| Benzaclin | Subjective Tolerability of Irritation Assessment (Participant Assessed): Itching | Baseline | 0.1 score on a scale |
| Benzaclin | Subjective Tolerability of Irritation Assessment (Participant Assessed): Itching | Week 8 | 0.3 score on a scale |
| Benzaclin | Subjective Tolerability of Irritation Assessment (Participant Assessed): Itching | Week 2 | 0.5 score on a scale |
| Benzaclin | Subjective Tolerability of Irritation Assessment (Participant Assessed): Itching | Week 16 | 0.3 score on a scale |
| Benzaclin | Subjective Tolerability of Irritation Assessment (Participant Assessed): Itching | Week 4 | 0.4 score on a scale |
Primary
Subjective Tolerability of Irritation Assessment (Participant Assessed): Stinging
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
Population: 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 | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Effaclar | Subjective Tolerability of Irritation Assessment (Participant Assessed): Stinging | Baseline | 0.1 score on a scale |
| Effaclar | Subjective Tolerability of Irritation Assessment (Participant Assessed): Stinging | Week 2 | 0.8 score on a scale |
| Effaclar | Subjective Tolerability of Irritation Assessment (Participant Assessed): Stinging | Week 4 | 0.4 score on a scale |
| Effaclar | Subjective Tolerability of Irritation Assessment (Participant Assessed): Stinging | Week 8 | 0.3 score on a scale |
| Effaclar | Subjective Tolerability of Irritation Assessment (Participant Assessed): Stinging | Week 12 | 0.2 score on a scale |
| Effaclar | Subjective Tolerability of Irritation Assessment (Participant Assessed): Stinging | Week 16 | 0.1 score on a scale |
| Benzaclin | Subjective Tolerability of Irritation Assessment (Participant Assessed): Stinging | Week 12 | 0.3 score on a scale |
| Benzaclin | Subjective Tolerability of Irritation Assessment (Participant Assessed): Stinging | Baseline | 0.0 score on a scale |
| Benzaclin | Subjective Tolerability of Irritation Assessment (Participant Assessed): Stinging | Week 8 | 0.5 score on a scale |
| Benzaclin | Subjective Tolerability of Irritation Assessment (Participant Assessed): Stinging | Week 2 | 0.8 score on a scale |
| Benzaclin | Subjective Tolerability of Irritation Assessment (Participant Assessed): Stinging | Week 16 | 0.2 score on a scale |
| Benzaclin | Subjective Tolerability of Irritation Assessment (Participant Assessed): Stinging | Week 4 | 0.4 score on a scale |
Primary
Subjective Tolerability of Irritation Assessment (Participant Assessed): Tingling
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
Population: 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 | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Effaclar | Subjective Tolerability of Irritation Assessment (Participant Assessed): Tingling | Baseline | 0.1 score on a scale |
| Effaclar | Subjective Tolerability of Irritation Assessment (Participant Assessed): Tingling | Week 2 | 0.8 score on a scale |
| Effaclar | Subjective Tolerability of Irritation Assessment (Participant Assessed): Tingling | Week 4 | 0.4 score on a scale |
| Effaclar | Subjective Tolerability of Irritation Assessment (Participant Assessed): Tingling | Week 8 | 0.3 score on a scale |
| Effaclar | Subjective Tolerability of Irritation Assessment (Participant Assessed): Tingling | Week 12 | 0.2 score on a scale |
| Effaclar | Subjective Tolerability of Irritation Assessment (Participant Assessed): Tingling | Week 16 | 0.1 score on a scale |
| Benzaclin | Subjective Tolerability of Irritation Assessment (Participant Assessed): Tingling | Week 12 | 0.3 score on a scale |
| Benzaclin | Subjective Tolerability of Irritation Assessment (Participant Assessed): Tingling | Baseline | 0.0 score on a scale |
| Benzaclin | Subjective Tolerability of Irritation Assessment (Participant Assessed): Tingling | Week 8 | 0.5 score on a scale |
| Benzaclin | Subjective Tolerability of Irritation Assessment (Participant Assessed): Tingling | Week 2 | 0.8 score on a scale |
| Benzaclin | Subjective Tolerability of Irritation Assessment (Participant Assessed): Tingling | Week 16 | 0.2 score on a scale |
| Benzaclin | Subjective Tolerability of Irritation Assessment (Participant Assessed): Tingling | Week 4 | 0.4 score on a scale |
Primary
Treatment Tolerability Assessment: Dryness
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
Population: 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 | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Effaclar | Treatment Tolerability Assessment: Dryness | Baseline | 0.4 score on a scale |
| Effaclar | Treatment Tolerability Assessment: Dryness | Week 2 | 0.9 score on a scale |
| Effaclar | Treatment Tolerability Assessment: Dryness | Week 4 | 0.6 score on a scale |
| Effaclar | Treatment Tolerability Assessment: Dryness | Week 8 | 0.2 score on a scale |
| Effaclar | Treatment Tolerability Assessment: Dryness | Week 12 | 0.2 score on a scale |
| Effaclar | Treatment Tolerability Assessment: Dryness | Week 16 | 0.0 score on a scale |
| Benzaclin | Treatment Tolerability Assessment: Dryness | Week 12 | 0.2 score on a scale |
| Benzaclin | Treatment Tolerability Assessment: Dryness | Baseline | 0.2 score on a scale |
| Benzaclin | Treatment Tolerability Assessment: Dryness | Week 8 | 0.2 score on a scale |
| Benzaclin | Treatment Tolerability Assessment: Dryness | Week 2 | 0.7 score on a scale |
| Benzaclin | Treatment Tolerability Assessment: Dryness | Week 16 | 0.0 score on a scale |
| Benzaclin | Treatment Tolerability Assessment: Dryness | Week 4 | 0.3 score on a scale |
Primary
Treatment Tolerability Assessment: Edema
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
Population: 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 | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Effaclar | Treatment Tolerability Assessment: Edema | Baseline | 0.1 score on a scale |
| Effaclar | Treatment Tolerability Assessment: Edema | Week 2 | 0.2 score on a scale |
| Effaclar | Treatment Tolerability Assessment: Edema | Week 4 | 0.1 score on a scale |
| Effaclar | Treatment Tolerability Assessment: Edema | Week 8 | 0.0 score on a scale |
| Effaclar | Treatment Tolerability Assessment: Edema | Week 12 | 0.0 score on a scale |
| Effaclar | Treatment Tolerability Assessment: Edema | Week 16 | 0.0 score on a scale |
| Benzaclin | Treatment Tolerability Assessment: Edema | Week 12 | 0.0 score on a scale |
| Benzaclin | Treatment Tolerability Assessment: Edema | Baseline | 0.1 score on a scale |
| Benzaclin | Treatment Tolerability Assessment: Edema | Week 8 | 0.1 score on a scale |
| Benzaclin | Treatment Tolerability Assessment: Edema | Week 2 | 0.2 score on a scale |
| Benzaclin | Treatment Tolerability Assessment: Edema | Week 16 | 0.0 score on a scale |
| Benzaclin | Treatment Tolerability Assessment: Edema | Week 4 | 0.2 score on a scale |
Primary
Treatment Tolerability Assessment: Erythema
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
Population: 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 | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Effaclar | Treatment Tolerability Assessment: Erythema | Week 8 | 0.1 score on a scale |
| Effaclar | Treatment Tolerability Assessment: Erythema | Baseline | 0.3 score on a scale |
| Effaclar | Treatment Tolerability Assessment: Erythema | Week 12 | 0.2 score on a scale |
| Effaclar | Treatment Tolerability Assessment: Erythema | Week 4 | 0.3 score on a scale |
| Effaclar | Treatment Tolerability Assessment: Erythema | Week 16 | 0.1 score on a scale |
| Effaclar | Treatment Tolerability Assessment: Erythema | Week 2 | 0.6 score on a scale |
| Benzaclin | Treatment Tolerability Assessment: Erythema | Week 16 | 0.1 score on a scale |
| Benzaclin | Treatment Tolerability Assessment: Erythema | Week 2 | 0.4 score on a scale |
| Benzaclin | Treatment Tolerability Assessment: Erythema | Week 4 | 0.4 score on a scale |
| Benzaclin | Treatment Tolerability Assessment: Erythema | Week 8 | 0.2 score on a scale |
| Benzaclin | Treatment Tolerability Assessment: Erythema | Week 12 | 0.2 score on a scale |
| Benzaclin | Treatment Tolerability Assessment: Erythema | Baseline | 0.4 score on a scale |
Primary
Treatment Tolerability Assessment: Peeling
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
Population: 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 | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Effaclar | Treatment Tolerability Assessment: Peeling | Baseline | 0.1 score on a scale |
| Effaclar | Treatment Tolerability Assessment: Peeling | Week 2 | 0.5 score on a scale |
| Effaclar | Treatment Tolerability Assessment: Peeling | Week 4 | 0.5 score on a scale |
| Effaclar | Treatment Tolerability Assessment: Peeling | Week 8 | 0.1 score on a scale |
| Effaclar | Treatment Tolerability Assessment: Peeling | Week 12 | 0.1 score on a scale |
| Effaclar | Treatment Tolerability Assessment: Peeling | Week 16 | 0.0 score on a scale |
| Benzaclin | Treatment Tolerability Assessment: Peeling | Week 12 | 0.1 score on a scale |
| Benzaclin | Treatment Tolerability Assessment: Peeling | Baseline | 0.0 score on a scale |
| Benzaclin | Treatment Tolerability Assessment: Peeling | Week 8 | 0.2 score on a scale |
| Benzaclin | Treatment Tolerability Assessment: Peeling | Week 2 | 0.6 score on a scale |
| Benzaclin | Treatment Tolerability Assessment: Peeling | Week 16 | 0.0 score on a scale |
| Benzaclin | Treatment Tolerability Assessment: Peeling | Week 4 | 0.3 score on a scale |