Acne Vulgaris
Conditions
Keywords
Acne, Acne Vulgaris
Brief summary
The purpose of this study is to compare the tolerability of topical combination therapies in the treatment of facial acne.
Detailed description
The purpose of this study is to compare the tolerability of topical combination therapies in the treatment of facial acne.
Interventions
DRUGBENZOYL PEROXIDE/ CLINDAMYCIN
Commencing at baseline, subjects will apply once daily both treatment arm #1 and treatment arm #2 in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. At 2 weeks, subjects will apply benzoyl peroxide/clindamycin gel to the entire face for an additional 6 weeks.
DRUGBENZOYL PEROXIDE/ ADAPALENE
Commencing at baseline, subjects will apply once daily both treatment arm #1 and treatment arm #2 in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. At 2 weeks, subjects will apply benzoyl peroxide/clindamycin gel to the entire face for an additional 6 weeks.
Sponsors
GlaxoSmithKline
Stiefel, a GSK Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or female subjects at least 21 years of age, in good general health with documented diagnosis of acne vulgaris. * Female subjects of childbearing potential must have a negative pregnancy test. Sexually active women of childbearing potential participating in the study must use a medically acceptable form of contraception Abstinence is considered an acceptable method of contraception. * Inflammatory (papules and pustules) and non-inflammatory (open and closed comedones) facial lesions. * The ability and willingness to follow all study procedures, attend all scheduled visits, and successfully complete the study * Capable of understanding and willing to provide signed and dated written voluntary informed consent (and any local or national authorization requirements) before any protocol specific procedures are performed
Exclusion criteria
* Female subjects who are pregnant, trying to become pregnant or breastfeeding. * Subjects who have any clinically relevant finding at their baseline physical other than acne vulgaris. * History or presence of regional enteritis or inflammatory bowel disease (eg, ulcerative colitis, pseudomembranous colitis, chronic diarrhea, or a history of antibiotic-associated colitis) or similar symptoms. * Use of topical antibiotics or anti-acne medications on the face and systemic antibiotics within the past 2 and 4 weeks, respectively. * Use of topical corticosteroids on the face or systemic corticosteroids within the past 4 weeks. Use of inhaled, intra-articular or intra-lesional (other than for facial acne lesions) steroids is acceptable. * Use of systemic retinoids within the past 6 months. * Facial procedures performed by an esthetician, beautician, physician, nurse, or other practitioner, within the past 4 weeks or during the conduct of the study. * Known hypersensitivity or previous allergic reaction to any of the active components, lincomycin, adapalene, clindamycin, benzoyl peroxide or excipients of the study product.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Erythema (Redness) | Weeks 1 and 2 | Signs and symptoms of tolerability (erythema, peeling, dryness, and irritant/allergic contact dermatitis)on the face. Erythema, peeling, dryness, and irritant/allergic contact dermatitis were graded using the following scale: 0, None; 1, Slight; 2, Moderate; 3, Intense. |
| Skin Dryness | Weeks 1 and 2 | Signs and symptoms of tolerability (erythema, peeling, dryness, and irritant/allergic contact dermatitis)on the face. Erythema, peeling, dryness, and irritant/allergic contact dermatitis were graded using the following scale: 0, None; 1, Slight; 2, Moderate; 3, Intense. |
| Skin Peeling | Weeks 1 and 2 | Signs and symptoms of tolerability (erythema, peeling, dryness, and irritant/allergic contact dermatitis)on the face. Erythema, peeling, dryness, and irritant/allergic contact dermatitis were graded using the following scale: 0, None; 1, Slight; 2, Moderate; 3,Intense. |
| Irritant/Allergic Contact Dermatitis | Weeks 1 and 2 | Signs and symptoms of tolerability (erythema, peeling, dryness, and irritant/allergic contact dermatitis)on the face. Erythema, peeling, dryness, and irritant/allergic contact dermatitis were graded using the following scale: 0, None; 1, Slight; 2, Moderate; 3, Intense. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Investigators Static Global Assessment | Baseline, Weeks 5, 8 | ISGA is evaluated using the following scale: 0, Clear: Clear skin with no lesions; 1, Almost Clear: Rare non-inflammatory lesions; 2, Mild: Some non-inflammatory lesions with no more than a few inflammatory lesions but no nodular lesions); 3, Moderate: Up to many non-inflammatory lesions and may have some inflammatory lesions, but no more than 1 small nodular lesion; 4, Severe: Up to many non-inflammatory and inflammatory lesions, but no more than a few nodular lesions; 5, Very Severe: Many non-inflammatory and inflammatory lesions and more than a few nodular lesions. May have cystic lesions. |
| Total Acne Lesion Counts | Baseline, Weeks 5 and 8 | Total acne lesion counts - includes both inflammatory acne lesions (pustules, papules), noninflammatory lesions (whiteheads and blackheads), |
| Inflammatory Acne Lesion Counts | Baseline, Weeks 5 and 8 | Total number of inflammatory acne lesions (pustules, papules) at each timepoint. |
| Non-inflammatory Acne Lesion Counts | Baseline, Weeks 5 and 8 | Total number of non-inflammatory acne lesions (whiteheads and blackheads) at each timepoint. |
| Skindex-29 Quality of Life Questionnaire (QoL) - Symptomatic Domain | Baseline, Weeks 2 and 8 | Skindex-29 is a self-administered (by participants at each time point) QoL questionnaire comprised of 29 items (it.) scored on a 5-point scale (0=never, 1=rarely, 2=sometimes, 3=often, 4=all the time) covering 3 domains: emotional (10 it.); symptomatic (7 it.); functional (12 it.). Domain scores range from 0 to 40, 0 to 28, and 0 to 48, respectively. Lower scores=better QoL. The symptomatic score (score=0 to 28)=(sum of the 7 individual item scores) \* 100/28. |
| Quality of Life Questionnaire - Emotional Domain | Baseline, Weeks 2 and 8 | Skindex-29 is a self-administered (by participants at each time point) QoL questionnaire comprised of 29 items (it.) scored on a 5-point scale (0=never, 1=rarely, 2=sometimes, 3=often, 4=all the time) covering 3 domains: emotional (10 it.); symptomatic (7 it.); functional (12 it.). Domain scores range from 0 to 40, 0 to 28, and 0 to 48, respectively. Lower scores=better QoL. The emotional score (score=0 to 40)=(sum of the 10 individual item scores) \* 100/40. |
| Quality of Life Questionnaire - Functional Domain | Baseline, Weeks 2 and 8 | Skindex-29 is a self-administered (by participants at each time point) QoL questionnaire comprised of 29 items (it.) scored on a 5-point scale (0=never, 1=rarely, 2=sometimes, 3=often, 4=all the time) covering 3 domains: emotional (10 it.); symptomatic (7 it.); functional (12 it.). Domain scores range from 0 to 40, 0 to 28, and 0 to 48, respectively. Lower scores=better QoL. The functional score (score=0 to 48)=(sum of the 12 individual item scores) \* 100/48. |
| Quality of Life Questionnaire - Global Score | Baseline, Weeks 2 and 8 | Skindex-29 is a self-administered (by participants at each time point) QoL questionnaire comprised of 29 items (it.) scored on a 5-point scale (0=never, 1=rarely, 2=sometimes, 3=often, 4=all the time) covering 3 domains: emotional (10 it.); symptomatic (7 it.); functional (12 it.). Domain scores range from 0 to 40, 0 to 28, and 0 to 48, respectively. Lower scores=better QoL. A Global Score (range 0-100)=(sum of all 29 individual item scores) \* 100/116. |
| Product Acceptability and Preference Questionnaire - Severity of Redness at Weeks 1 and 2 | Weeks 1 and 2 | Product Acceptability and Preference Questionnaire were completed by the subject at each timepoint using the following scale: 0, None; 1, Very minimal; 2, Mild; 3, Moderate; 4, Severe. |
| Product Acceptability and Preference Questionnaire - Severity of Redness at Week 8 | Week 8 | Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 0, None; 1, Very minimal; 2, Mild; 3, Moderate; 4, Severe. |
| Product Acceptability and Preference Questionnaire - Severity of Dryness at Weeks 1 and 2 | Weeks 1 and 2 | Product Acceptability and Preference Questionnaire were completed by the subject at each timepoint using the following scale: 0, None; 1, Very minimal; 2, Mild; 3, Moderate; 4, Severe. |
| Product Acceptability and Preference Questionnaire - Severity of Dryness at Week 8 | Week 8 | Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 0, None; 1, Very minimal; 2, Mild; 3, Moderate; 4, Severe. |
| Product Acceptability and Preference Questionnaire - Severity of Burning at Weeks 1 and 2 | Weeks 1 and 2 | Product Acceptability and Preference Questionnaire were completed by the subject at each timepoint using the following scale: 0, None; 1, Very minimal; 2, Mild; 3, Moderate; 4, Severe. |
| Product Acceptability and Preference Questionnaire - Severity of Burning at Week 8 | Week 8 | Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 0, None; 1, Very minimal; 2, Mild; 3, Moderate; 4, Severe. |
| Product Acceptability and Preference Questionnaire - Severity of Itching at Weeks 1 and 2 | Weeks 1 and 2 | Product Acceptability and Preference Questionnaire were completed by the subject at each timepoint using the following scale: 0, None; 1, Very minimal; 2, Mild; 3, Moderate; 4, Severe. |
| Product Acceptability and Preference Questionnaire - Severity of Itching at Week 8 | Week 8 | Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 0, None; 1, Very minimal; 2, Mild; 3, Moderate; 4, Severe. |
| Product Acceptability and Preference Questionnaire - Severity of Scaling at Weeks 1 and 2 | Weeks 1 and 2 | Product Acceptability and Preference Questionnaire were completed by the subject at each timepoint using the following scale: 0, None; 1, Very minimal; 2, Mild; 3, Moderate; 4, Severe; 5, Very Severe. |
| Product Acceptability and Preference Questionnaire - Severity of Scaling at Week 8 | Week 8 | Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 0, None; 1, Very minimal; 2, Mild; 3, Moderate; 4, Severe; 5, Very Severe. |
| Product Acceptability and Preference Questionnaire - Ease of Application of Product at Weeks 1 and 2 | Weeks 1 and 2 | Product Acceptability and Preference Questionnaire were completed by the subject at each timepoint using the following scale: 1, Very easy; 2, Easy; 3, Neutral; 4, Difficult. |
| Product Acceptability and Preference Questionnaire - Ease of Application of Product at Week 8 | Week 8 | Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 1, Very easy; 2, Easy; 3, Neutral; 4, Difficult. |
| Product Acceptability and Preference Questionnaire - Comfort of Skin at Weeks 1 and 2 | Weeks 1 and 2 | Product Acceptability and Preference Questionnaire were completed by the subject at each timepoint using the following scale: 1, Very Comfortable; 2, Comfortable; 3, Somewhat Comfortable; 4, Somewhat Uncomfortable; 5, Uncomfortable. |
| Product Acceptability and Preference Questionnaire - Comfort of Skin at Week 8 | Week 8 | Product Acceptability and Preference Questionnaire were completed by the subject at each timepoint using the following scale: 1, Very Comfortable; 2, Comfortable; 3, Somewhat Comfortable; 4, Somewhat Uncomfortable; 5, Uncomfortable. |
| Product Acceptability and Preference Questionnaire - Which Study Product is Subject More Satisfied With? at Weeks 1 and 2 | Weeks 1 and 2 | Product Acceptability and Preference Questionnaire were completed by the subject at each timepoint using the following choices: Epiduo, Clindoxyl Gel, Both Treatments Equally. |
| Product Acceptability and Preference Questionnaire - Comparison of Study Products Used in the Past at Week 8 | Week 8 | Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 1, More Satisfied; 2, Somewhat More Satisfied; 3, Neither Satisfied or Dissatisfied; 4, Somewhat More Dissatisfied; 5, More Dissatisfied. |
| Product Acceptability and Preference Questionnaire - Decrease of Acne Breakouts by Study Products at Weeks 1 and 2 | Weeks 1 and 2 | Product Acceptability and Preference Questionnaire were completed by the subject at each timepoint using the following scale: 1, Highly Favorable; 2, Favorable; 3, Neutral; 4, Unfavorable; 5, Uncomfortable. |
| Product Acceptability and Preference Questionnaire - Decrease of Acne Breakouts by Study Products at Week 8 | Week 8 | Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 1, Highly Favorable; 2, Favorable; 3, Neutral; 4, Unfavorable; 5, More Dissatisfied. |
| Product Acceptability and Preference Questionnaire - Compliance at Weeks 1 and 2 | Weeks 1 and 2 | Product Acceptability and Preference Questionnaire were completed by the subject at each timepoint using the following scale: 0, Not Compliant at all; 1, Mostly Compliant; 2, Very Compliant. |
| Product Acceptability and Preference Questionnaire - Compliance at Week 8 | Week 8 | Product Acceptability and Preference Questionnaire were completed by the subject at week 8 by answering Yes or No to the following question: Did you use the product every day?. When only one product was applied to the face, subjects were asked to rate their compliance by answering the aforementioned question, rather than rating compliance on a 0-2 scale. |
| Product Acceptability and Preference Questionnaire - Feeling of Hydrated and Moisturized Skin at Weeks 1 and 2 | Weeks 1 and 2 | Product Acceptability and Preference Questionnaire were completed by the subject at each timepoint by answering Yes or No to the following question: Did you feel that your skin was hydrated and moisturized while you were on your study product? |
| Product Acceptability and Preference Questionnaire - Feeling of Hydrated and Moisturized Skin at Week 8 | Week 8 | Product Acceptability and Preference Questionnaire were completed by the subject at each timepoint by answering Yes or No to the following question: Did you feel that your skin was hydrated and moisturized while you were on your study product? |
| Product Acceptability and Preference Questionnaire - Use of Study Product if Choice to Continue Acne Treatment at Week 1 and 2 | Weeks 1 and 2 | Product Acceptability and Preference Questionnaire were completed by the subject at each timepoint by answering Yes or No to the following question: If you were to choose to continue treatment for your acne, would you use the study product? |
| Product Acceptability and Preference Questionnaire - Use of Study Product if Choice to Continue Acne Treatment at Week 8 | Week 8 | Product Acceptability and Preference Questionnaire were completed by the subject at 8 week timepoint by answering Yes or No to the following question: If you were to choose to continue treatment for your acne, would you use the study product? |
| Product Acceptability and Preference Questionnaire - Ease of Use Wtih Make-Up at Weeks 1 and 2 | Weeks 1 and 2 | Product Acceptability and Preference Questionnaire were completed by the subject at each timepoint using the following scale: 0, Not Applicable; 1, Very Easy; 2, Easy; 3, Neutral; 4, Difficult; 5, Very Difficult. |
| Product Acceptability and Preference Questionnaire - Ease of Use With Make-Up at Week 8 | Week 8 | Product Acceptability and Preference Questionnaire were completed by the subject at each timepoint using the following scale: 0, Not Applicable; 1, Very Easy; 2, Easy; 3, Neutral; 4, Difficult; 5, Very Difficult. |
| Erythema (Redness) | Weeks 5 and 8 | Signs and symptoms of tolerability (erythema, peeling, dryness, and irritant/allergic contact dermatitis)on the face. Erythema, peeling, dryness, and irritant/allergic contact dermatitis were graded using the following scale: 0, None; 1, Slight; 2, Moderate; 3, Intense. |
| Product Acceptability and Preference Questionnaire - Overall Satisfaction of Study Product at Week 8 | Week 8 | Product Acceptability and Preference Questionnaire were completed by the subject at each timepoint using the following scale: 1, Very Satisfied; 2, Satisfied; 3, Neutral; 4, Unsatisfied; 5, Very Unsatisfied. |
| Product Acceptability and Preference Questionnaire - Overall Satisfaction of Study Product at Weeks 1 and 2 | Weeks 1 and 2 | Product Acceptability and Preference Questionnaire were completed by the subject at each timepoint using the following scale: 1, Very Satisfied; 2, Satisfied; 3, Neutral; 4, Unsatisfied; 5, Very Unsatisfied. |
| Skin Dryness | Weeks 5 and 8 | Signs and symptoms of tolerability (erythema, peeling, dryness, and irritant/allergic contact dermatitis)on the face. Erythema, peeling, dryness, and irritant/allergic contact dermatitis were graded using the following scale: 0, None; 1, Slight; 2, Moderate; 3, Intense. |
| Skin Peeling | Weeks 5 and 8 | Signs and symptoms of tolerability (erythema, peeling, dryness, and irritant/allergic contact dermatitis)on the face. Erythema, peeling, dryness, and irritant/allergic contact dermatitis were graded using the following scale: 0, None; 1, Slight; 2, Moderate; 3, Intense. |
| Irritant/Allergic Contact Dermatitis | Weeks 5 and 8 | Signs and symptoms of tolerability (erythema, peeling, dryness, and irritant/allergic contact dermatitis)on the face. Erythema, peeling, dryness, and irritant/allergic contact dermatitis were graded using the following scale: 0, None; 1, Slight; 2, Moderate; 3, Intense. |
Countries
Argentina
Participant flow
Recruitment details
Clinical research center
Participants by arm
| Arm | Count |
|---|---|
| Clindoxyl and Epiduo Gels Commencing at baseline, participants will apply clindoxyl and epiduo gels once daily in a bilateral split-face fashion (Split Face Treatment Period; allocation to left and right side randomly assigned) for an initial 2 weeks. At Week 5, during the Full Face Treatment Period, participants will apply clindoxyl gel to the entire face for an additional 4 weeks. | 48 |
| Total | 48 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Full Face Treatment (Weeks 5 and 8) | Adverse Event | 1 |
| Full Face Treatment (Weeks 5 and 8) | Lost to Follow-up | 1 |
| Full Face Treatment (Weeks 5 and 8) | Pregnancy | 1 |
Baseline characteristics
| Characteristic | Clindoxyl and Epiduo Gels |
|---|---|
| Age, Continuous | 27.6 years STANDARD_DEVIATION 5.5 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 33 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 15 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Gender Female | 10 Participants |
| Gender Male | 38 Participants |
| Inflammatory Acne Lesion Count | 14.2 Inflammatory lesions STANDARD_DEVIATION 9.1 |
| Investigators Static Global Assessment (ISGA) Mild | 14 Participants |
| Investigators Static Global Assessment (ISGA) Moderate | 31 Participants |
| Investigators Static Global Assessment (ISGA) Severe | 3 Participants |
| Non-Inflammatory Acne Lesion Count | 24.8 Non-Infammatory acne lesions STANDARD_DEVIATION 12.8 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 48 Participants |
| Region of Enrollment Argentina | 48 participants |
| Total Acne Lesion Count | 39.1 Acne lesions STANDARD_DEVIATION 13 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 44 / 48 |
| serious Total, serious adverse events | 0 / 48 |
Outcome results
Primary
Erythema (Redness)
Signs and symptoms of tolerability (erythema, peeling, dryness, and irritant/allergic contact dermatitis)on the face. Erythema, peeling, dryness, and irritant/allergic contact dermatitis were graded using the following scale: 0, None; 1, Slight; 2, Moderate; 3, Intense.
Time frame: Weeks 1 and 2
Population: Intent-to-Treat (ITT)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Clindoxyl Gel | Erythema (Redness) | Week 1 | 0.66 units on a scale | Standard Deviation 0.7 |
| Clindoxyl Gel | Erythema (Redness) | Week 2 | 0.55 units on a scale | Standard Deviation 0.62 |
| Epiduo Gel | Erythema (Redness) | Week 1 | 0.91 units on a scale | Standard Deviation 0.78 |
| Epiduo Gel | Erythema (Redness) | Week 2 | 0.74 units on a scale | Standard Deviation 0.64 |
Primary
Irritant/Allergic Contact Dermatitis
Signs and symptoms of tolerability (erythema, peeling, dryness, and irritant/allergic contact dermatitis)on the face. Erythema, peeling, dryness, and irritant/allergic contact dermatitis were graded using the following scale: 0, None; 1, Slight; 2, Moderate; 3, Intense.
Time frame: Weeks 1 and 2
Population: ITT
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Clindoxyl Gel | Irritant/Allergic Contact Dermatitis | Week 1 | 0.04 units on a scale | Standard Deviation 0.2 |
| Clindoxyl Gel | Irritant/Allergic Contact Dermatitis | Week 2 | 0.04 units on a scale | Standard Deviation 0.2 |
| Epiduo Gel | Irritant/Allergic Contact Dermatitis | Week 1 | 0.04 units on a scale | Standard Deviation 0.2 |
| Epiduo Gel | Irritant/Allergic Contact Dermatitis | Week 2 | 0.04 units on a scale | Standard Deviation 0.2 |
Primary
Skin Dryness
Signs and symptoms of tolerability (erythema, peeling, dryness, and irritant/allergic contact dermatitis)on the face. Erythema, peeling, dryness, and irritant/allergic contact dermatitis were graded using the following scale: 0, None; 1, Slight; 2, Moderate; 3, Intense.
Time frame: Weeks 1 and 2
Population: ITT
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Clindoxyl Gel | Skin Dryness | Week 1 | 0.47 units on a scale | Standard Deviation 0.55 |
| Clindoxyl Gel | Skin Dryness | Week 2 | 0.40 units on a scale | Standard Deviation 0.58 |
| Epiduo Gel | Skin Dryness | Week 1 | 0.96 units on a scale | Standard Deviation 0.75 |
| Epiduo Gel | Skin Dryness | Week 2 | 0.64 units on a scale | Standard Deviation 0.74 |
Primary
Skin Peeling
Signs and symptoms of tolerability (erythema, peeling, dryness, and irritant/allergic contact dermatitis)on the face. Erythema, peeling, dryness, and irritant/allergic contact dermatitis were graded using the following scale: 0, None; 1, Slight; 2, Moderate; 3,Intense.
Time frame: Weeks 1 and 2
Population: ITT
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Clindoxyl Gel | Skin Peeling | Week 1 | 0.34 units on a scale | Standard Deviation 0.52 |
| Clindoxyl Gel | Skin Peeling | Week 2 | 0.40 units on a scale | Standard Deviation 0.61 |
| Epiduo Gel | Skin Peeling | Week 1 | 0.68 units on a scale | Standard Deviation 0.78 |
| Epiduo Gel | Skin Peeling | Week 2 | 0.60 units on a scale | Standard Deviation 0.68 |
Secondary
Erythema (Redness)
Signs and symptoms of tolerability (erythema, peeling, dryness, and irritant/allergic contact dermatitis)on the face. Erythema, peeling, dryness, and irritant/allergic contact dermatitis were graded using the following scale: 0, None; 1, Slight; 2, Moderate; 3, Intense.
Time frame: Weeks 5 and 8
Population: ITT
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Clindoxyl Gel | Erythema (Redness) | Week 5 | 0.22 units on a scale | Standard Deviation 0.42 |
| Clindoxyl Gel | Erythema (Redness) | Week 8 | 0.19 units on a scale | Standard Deviation 0.5 |
Secondary
Inflammatory Acne Lesion Counts
Total number of inflammatory acne lesions (pustules, papules) at each timepoint.
Time frame: Baseline, Weeks 5 and 8
Population: ITT
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Clindoxyl Gel | Inflammatory Acne Lesion Counts | Baseline | 14.23 Acne Lesions | Standard Deviation 9.06 |
| Clindoxyl Gel | Inflammatory Acne Lesion Counts | Week 5 | 4.60 Acne Lesions | Standard Deviation 3.93 |
| Clindoxyl Gel | Inflammatory Acne Lesion Counts | Week 8 | 4.26 Acne Lesions | Standard Deviation 5.84 |
Secondary
Investigators Static Global Assessment
ISGA is evaluated using the following scale: 0, Clear: Clear skin with no lesions; 1, Almost Clear: Rare non-inflammatory lesions; 2, Mild: Some non-inflammatory lesions with no more than a few inflammatory lesions but no nodular lesions); 3, Moderate: Up to many non-inflammatory lesions and may have some inflammatory lesions, but no more than 1 small nodular lesion; 4, Severe: Up to many non-inflammatory and inflammatory lesions, but no more than a few nodular lesions; 5, Very Severe: Many non-inflammatory and inflammatory lesions and more than a few nodular lesions. May have cystic lesions.
Time frame: Baseline, Weeks 5, 8
Population: For the first 2 weeks, participants apply one of the drugs (Clindoxyl or Epiduo) to one side of the face and the other drug to the other side of their face. After week 2, participants apply Clindoxyl to their entire face and do not use Epiduo.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Clindoxyl Gel | Investigators Static Global Assessment | Baseline | 2.77 units on a scale | Standard Deviation 0.56 |
| Clindoxyl Gel | Investigators Static Global Assessment | Week 5 | 1.89 units on a scale | Standard Deviation 0.75 |
| Clindoxyl Gel | Investigators Static Global Assessment | Week 8 | 1.62 units on a scale | Standard Deviation 0.92 |
Secondary
Irritant/Allergic Contact Dermatitis
Signs and symptoms of tolerability (erythema, peeling, dryness, and irritant/allergic contact dermatitis)on the face. Erythema, peeling, dryness, and irritant/allergic contact dermatitis were graded using the following scale: 0, None; 1, Slight; 2, Moderate; 3, Intense.
Time frame: Weeks 5 and 8
Population: ITT
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Clindoxyl Gel | Irritant/Allergic Contact Dermatitis | Week 5 | 0.00 units on a scale | Standard Deviation 0 |
| Clindoxyl Gel | Irritant/Allergic Contact Dermatitis | Week 8 | 0.00 units on a scale | Standard Deviation 0 |
Secondary
Non-inflammatory Acne Lesion Counts
Total number of non-inflammatory acne lesions (whiteheads and blackheads) at each timepoint.
Time frame: Baseline, Weeks 5 and 8
Population: ITT
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Clindoxyl Gel | Non-inflammatory Acne Lesion Counts | Baseline | 24.83 Acne Lesions | Standard Deviation 12.84 |
| Clindoxyl Gel | Non-inflammatory Acne Lesion Counts | Week 5 | 11.36 Acne Lesions | Standard Deviation 7.89 |
| Clindoxyl Gel | Non-inflammatory Acne Lesion Counts | Week 8 | 9.51 Acne Lesions | Standard Deviation 8.53 |
Secondary
Product Acceptability and Preference Questionnaire - Comfort of Skin at Week 8
Product Acceptability and Preference Questionnaire were completed by the subject at each timepoint using the following scale: 1, Very Comfortable; 2, Comfortable; 3, Somewhat Comfortable; 4, Somewhat Uncomfortable; 5, Uncomfortable.
Time frame: Week 8
Population: ITT
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Clindoxyl Gel | Product Acceptability and Preference Questionnaire - Comfort of Skin at Week 8 | 1.83 Units on a scale | Standard Deviation 0.92 |
Secondary
Product Acceptability and Preference Questionnaire - Comfort of Skin at Weeks 1 and 2
Product Acceptability and Preference Questionnaire were completed by the subject at each timepoint using the following scale: 1, Very Comfortable; 2, Comfortable; 3, Somewhat Comfortable; 4, Somewhat Uncomfortable; 5, Uncomfortable.
Time frame: Weeks 1 and 2
Population: ITT
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Clindoxyl Gel | Product Acceptability and Preference Questionnaire - Comfort of Skin at Weeks 1 and 2 | Week 1 | 2.81 Units on a scale | Standard Deviation 0.88 |
| Clindoxyl Gel | Product Acceptability and Preference Questionnaire - Comfort of Skin at Weeks 1 and 2 | Week 2 | 2.39 Units on a scale | Standard Deviation 0.93 |
| Epiduo Gel | Product Acceptability and Preference Questionnaire - Comfort of Skin at Weeks 1 and 2 | Week 1 | 3.15 Units on a scale | Standard Deviation 1.08 |
| Epiduo Gel | Product Acceptability and Preference Questionnaire - Comfort of Skin at Weeks 1 and 2 | Week 2 | 2.67 Units on a scale | Standard Deviation 0.94 |
Secondary
Product Acceptability and Preference Questionnaire - Comparison of Study Products Used in the Past at Week 8
Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 1, More Satisfied; 2, Somewhat More Satisfied; 3, Neither Satisfied or Dissatisfied; 4, Somewhat More Dissatisfied; 5, More Dissatisfied.
Time frame: Week 8
Population: ITT
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Clindoxyl Gel | Product Acceptability and Preference Questionnaire - Comparison of Study Products Used in the Past at Week 8 | 1.63 Units on a scale | Standard Deviation 1.08 |
Secondary
Product Acceptability and Preference Questionnaire - Compliance at Week 8
Product Acceptability and Preference Questionnaire were completed by the subject at week 8 by answering Yes or No to the following question: Did you use the product every day?. When only one product was applied to the face, subjects were asked to rate their compliance by answering the aforementioned question, rather than rating compliance on a 0-2 scale.
Time frame: Week 8
Population: ITT
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Clindoxyl Gel | Product Acceptability and Preference Questionnaire - Compliance at Week 8 | Yes | 43 Participants |
| Clindoxyl Gel | Product Acceptability and Preference Questionnaire - Compliance at Week 8 | No | 3 Participants |
Secondary
Product Acceptability and Preference Questionnaire - Compliance at Weeks 1 and 2
Product Acceptability and Preference Questionnaire were completed by the subject at each timepoint using the following scale: 0, Not Compliant at all; 1, Mostly Compliant; 2, Very Compliant.
Time frame: Weeks 1 and 2
Population: ITT
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Clindoxyl Gel | Product Acceptability and Preference Questionnaire - Compliance at Weeks 1 and 2 | Week 1 | 1.91 Units on a scale | Standard Deviation 0.28 |
| Clindoxyl Gel | Product Acceptability and Preference Questionnaire - Compliance at Weeks 1 and 2 | Week 2 | 1.85 Units on a scale | Standard Deviation 0.42 |
| Epiduo Gel | Product Acceptability and Preference Questionnaire - Compliance at Weeks 1 and 2 | Week 1 | 1.91 Units on a scale | Standard Deviation 0.28 |
| Epiduo Gel | Product Acceptability and Preference Questionnaire - Compliance at Weeks 1 and 2 | Week 2 | 1.85 Units on a scale | Standard Deviation 0.42 |
Secondary
Product Acceptability and Preference Questionnaire - Decrease of Acne Breakouts by Study Products at Week 8
Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 1, Highly Favorable; 2, Favorable; 3, Neutral; 4, Unfavorable; 5, More Dissatisfied.
Time frame: Week 8
Population: ITT
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Clindoxyl Gel | Product Acceptability and Preference Questionnaire - Decrease of Acne Breakouts by Study Products at Week 8 | 1.53 Units on a scale | Standard Deviation 0.65 |
Secondary
Product Acceptability and Preference Questionnaire - Decrease of Acne Breakouts by Study Products at Weeks 1 and 2
Product Acceptability and Preference Questionnaire were completed by the subject at each timepoint using the following scale: 1, Highly Favorable; 2, Favorable; 3, Neutral; 4, Unfavorable; 5, Uncomfortable.
Time frame: Weeks 1 and 2
Population: ITT
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Clindoxyl Gel | Product Acceptability and Preference Questionnaire - Decrease of Acne Breakouts by Study Products at Weeks 1 and 2 | Week 1 | 1.87 Units on a scale | Standard Deviation 0.68 |
| Clindoxyl Gel | Product Acceptability and Preference Questionnaire - Decrease of Acne Breakouts by Study Products at Weeks 1 and 2 | Week 2 | 1.85 Units on a scale | Standard Deviation 0.84 |
| Epiduo Gel | Product Acceptability and Preference Questionnaire - Decrease of Acne Breakouts by Study Products at Weeks 1 and 2 | Week 1 | 2.04 Units on a scale | Standard Deviation 0.78 |
| Epiduo Gel | Product Acceptability and Preference Questionnaire - Decrease of Acne Breakouts by Study Products at Weeks 1 and 2 | Week 2 | 2.00 Units on a scale | Standard Deviation 0.7 |
Secondary
Product Acceptability and Preference Questionnaire - Ease of Application of Product at Week 8
Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 1, Very easy; 2, Easy; 3, Neutral; 4, Difficult.
Time frame: Week 8
Population: ITT
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Clindoxyl Gel | Product Acceptability and Preference Questionnaire - Ease of Application of Product at Week 8 | 1.26 Units on a scale | Standard Deviation 0.44 |
Secondary
Product Acceptability and Preference Questionnaire - Ease of Application of Product at Weeks 1 and 2
Product Acceptability and Preference Questionnaire were completed by the subject at each timepoint using the following scale: 1, Very easy; 2, Easy; 3, Neutral; 4, Difficult.
Time frame: Weeks 1 and 2
Population: ITT
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Clindoxyl Gel | Product Acceptability and Preference Questionnaire - Ease of Application of Product at Weeks 1 and 2 | Week 1 | 1.30 Units on a scale | Standard Deviation 0.51 |
| Clindoxyl Gel | Product Acceptability and Preference Questionnaire - Ease of Application of Product at Weeks 1 and 2 | Week 2 | 1.35 Units on a scale | Standard Deviation 0.53 |
| Epiduo Gel | Product Acceptability and Preference Questionnaire - Ease of Application of Product at Weeks 1 and 2 | Week 1 | 1.32 Units on a scale | Standard Deviation 0.56 |
| Epiduo Gel | Product Acceptability and Preference Questionnaire - Ease of Application of Product at Weeks 1 and 2 | Week 2 | 1.39 Units on a scale | Standard Deviation 0.61 |
Secondary
Product Acceptability and Preference Questionnaire - Ease of Use With Make-Up at Week 8
Product Acceptability and Preference Questionnaire were completed by the subject at each timepoint using the following scale: 0, Not Applicable; 1, Very Easy; 2, Easy; 3, Neutral; 4, Difficult; 5, Very Difficult.
Time frame: Week 8
Population: ITT
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Clindoxyl Gel | Product Acceptability and Preference Questionnaire - Ease of Use With Make-Up at Week 8 | 1.69 Units on a scale | Standard Deviation 0.87 |
Secondary
Product Acceptability and Preference Questionnaire - Ease of Use Wtih Make-Up at Weeks 1 and 2
Product Acceptability and Preference Questionnaire were completed by the subject at each timepoint using the following scale: 0, Not Applicable; 1, Very Easy; 2, Easy; 3, Neutral; 4, Difficult; 5, Very Difficult.
Time frame: Weeks 1 and 2
Population: ITT
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Clindoxyl Gel | Product Acceptability and Preference Questionnaire - Ease of Use Wtih Make-Up at Weeks 1 and 2 | Week 1 | 2.23 Units on a scale | Standard Deviation 1.24 |
| Clindoxyl Gel | Product Acceptability and Preference Questionnaire - Ease of Use Wtih Make-Up at Weeks 1 and 2 | Week 2 | 1.75 Units on a scale | Standard Deviation 0.93 |
| Epiduo Gel | Product Acceptability and Preference Questionnaire - Ease of Use Wtih Make-Up at Weeks 1 and 2 | Week 1 | 2.31 Units on a scale | Standard Deviation 1.38 |
| Epiduo Gel | Product Acceptability and Preference Questionnaire - Ease of Use Wtih Make-Up at Weeks 1 and 2 | Week 2 | 1.75 Units on a scale | Standard Deviation 0.93 |
Secondary
Product Acceptability and Preference Questionnaire - Feeling of Hydrated and Moisturized Skin at Week 8
Product Acceptability and Preference Questionnaire were completed by the subject at each timepoint by answering Yes or No to the following question: Did you feel that your skin was hydrated and moisturized while you were on your study product?
Time frame: Week 8
Population: ITT
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Clindoxyl Gel | Product Acceptability and Preference Questionnaire - Feeling of Hydrated and Moisturized Skin at Week 8 | Yes | 28 Participants |
| Clindoxyl Gel | Product Acceptability and Preference Questionnaire - Feeling of Hydrated and Moisturized Skin at Week 8 | No | 18 Participants |
Secondary
Product Acceptability and Preference Questionnaire - Feeling of Hydrated and Moisturized Skin at Weeks 1 and 2
Product Acceptability and Preference Questionnaire were completed by the subject at each timepoint by answering Yes or No to the following question: Did you feel that your skin was hydrated and moisturized while you were on your study product?
Time frame: Weeks 1 and 2
Population: ITT
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Clindoxyl Gel | Product Acceptability and Preference Questionnaire - Feeling of Hydrated and Moisturized Skin at Weeks 1 and 2 | Week 1 - Yes | 16 Participants |
| Clindoxyl Gel | Product Acceptability and Preference Questionnaire - Feeling of Hydrated and Moisturized Skin at Weeks 1 and 2 | Week 1 - No | 31 Participants |
| Clindoxyl Gel | Product Acceptability and Preference Questionnaire - Feeling of Hydrated and Moisturized Skin at Weeks 1 and 2 | Week 2 - Yes | 14 Participants |
| Clindoxyl Gel | Product Acceptability and Preference Questionnaire - Feeling of Hydrated and Moisturized Skin at Weeks 1 and 2 | Week 2 - No | 32 Participants |
| Epiduo Gel | Product Acceptability and Preference Questionnaire - Feeling of Hydrated and Moisturized Skin at Weeks 1 and 2 | Week 2 - No | 35 Participants |
| Epiduo Gel | Product Acceptability and Preference Questionnaire - Feeling of Hydrated and Moisturized Skin at Weeks 1 and 2 | Week 1 - Yes | 12 Participants |
| Epiduo Gel | Product Acceptability and Preference Questionnaire - Feeling of Hydrated and Moisturized Skin at Weeks 1 and 2 | Week 2 - Yes | 11 Participants |
| Epiduo Gel | Product Acceptability and Preference Questionnaire - Feeling of Hydrated and Moisturized Skin at Weeks 1 and 2 | Week 1 - No | 35 Participants |
Secondary
Product Acceptability and Preference Questionnaire - Overall Satisfaction of Study Product at Week 8
Product Acceptability and Preference Questionnaire were completed by the subject at each timepoint using the following scale: 1, Very Satisfied; 2, Satisfied; 3, Neutral; 4, Unsatisfied; 5, Very Unsatisfied.
Time frame: Week 8
Population: ITT
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Clindoxyl Gel | Product Acceptability and Preference Questionnaire - Overall Satisfaction of Study Product at Week 8 | 1.61 Units on a scale | Standard Deviation 0.98 |
Secondary
Product Acceptability and Preference Questionnaire - Overall Satisfaction of Study Product at Weeks 1 and 2
Product Acceptability and Preference Questionnaire were completed by the subject at each timepoint using the following scale: 1, Very Satisfied; 2, Satisfied; 3, Neutral; 4, Unsatisfied; 5, Very Unsatisfied.
Time frame: Weeks 1 and 2
Population: ITT
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Clindoxyl Gel | Product Acceptability and Preference Questionnaire - Overall Satisfaction of Study Product at Weeks 1 and 2 | Week 1 | 2.09 Units on a scale | Standard Deviation 0.69 |
| Clindoxyl Gel | Product Acceptability and Preference Questionnaire - Overall Satisfaction of Study Product at Weeks 1 and 2 | Week 2 | 1.76 Units on a scale | Standard Deviation 0.77 |
| Epiduo Gel | Product Acceptability and Preference Questionnaire - Overall Satisfaction of Study Product at Weeks 1 and 2 | Week 1 | 2.23 Units on a scale | Standard Deviation 0.87 |
| Epiduo Gel | Product Acceptability and Preference Questionnaire - Overall Satisfaction of Study Product at Weeks 1 and 2 | Week 2 | 1.98 Units on a scale | Standard Deviation 0.68 |
Secondary
Product Acceptability and Preference Questionnaire - Severity of Burning at Week 8
Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 0, None; 1, Very minimal; 2, Mild; 3, Moderate; 4, Severe.
Time frame: Week 8
Population: ITT
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Clindoxyl Gel | Product Acceptability and Preference Questionnaire - Severity of Burning at Week 8 | 0.36 Units on a scale | Standard Deviation 0.76 |
Secondary
Product Acceptability and Preference Questionnaire - Severity of Burning at Weeks 1 and 2
Product Acceptability and Preference Questionnaire were completed by the subject at each timepoint using the following scale: 0, None; 1, Very minimal; 2, Mild; 3, Moderate; 4, Severe.
Time frame: Weeks 1 and 2
Population: ITT
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Clindoxyl Gel | Product Acceptability and Preference Questionnaire - Severity of Burning at Weeks 1 and 2 | Week 1 | 0.91 Units on a scale | Standard Deviation 1.23 |
| Clindoxyl Gel | Product Acceptability and Preference Questionnaire - Severity of Burning at Weeks 1 and 2 | Week 2 | 0.72 Units on a scale | Standard Deviation 0.89 |
| Epiduo Gel | Product Acceptability and Preference Questionnaire - Severity of Burning at Weeks 1 and 2 | Week 1 | 1.68 Units on a scale | Standard Deviation 1.2 |
| Epiduo Gel | Product Acceptability and Preference Questionnaire - Severity of Burning at Weeks 1 and 2 | Week 2 | 1.30 Units on a scale | Standard Deviation 1.23 |
Secondary
Product Acceptability and Preference Questionnaire - Severity of Dryness at Week 8
Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 0, None; 1, Very minimal; 2, Mild; 3, Moderate; 4, Severe.
Time frame: Week 8
Population: ITT
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Clindoxyl Gel | Product Acceptability and Preference Questionnaire - Severity of Dryness at Week 8 | 0.64 Units on a scale | Standard Deviation 0.97 |
Secondary
Product Acceptability and Preference Questionnaire - Severity of Dryness at Weeks 1 and 2
Product Acceptability and Preference Questionnaire were completed by the subject at each timepoint using the following scale: 0, None; 1, Very minimal; 2, Mild; 3, Moderate; 4, Severe.
Time frame: Weeks 1 and 2
Population: ITT
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Clindoxyl Gel | Product Acceptability and Preference Questionnaire - Severity of Dryness at Weeks 1 and 2 | Week 1 | 1.30 Units on a scale | Standard Deviation 1.14 |
| Clindoxyl Gel | Product Acceptability and Preference Questionnaire - Severity of Dryness at Weeks 1 and 2 | Week 2 | 1.00 Units on a scale | Standard Deviation 0.87 |
| Epiduo Gel | Product Acceptability and Preference Questionnaire - Severity of Dryness at Weeks 1 and 2 | Week 1 | 1.81 Units on a scale | Standard Deviation 1.14 |
| Epiduo Gel | Product Acceptability and Preference Questionnaire - Severity of Dryness at Weeks 1 and 2 | Week 2 | 1.41 Units on a scale | Standard Deviation 1.17 |
Secondary
Product Acceptability and Preference Questionnaire - Severity of Itching at Week 8
Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 0, None; 1, Very minimal; 2, Mild; 3, Moderate; 4, Severe.
Time frame: Week 8
Population: ITT
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Clindoxyl Gel | Product Acceptability and Preference Questionnaire - Severity of Itching at Week 8 | 0.26 Units on a scale | Standard Deviation 0.49 |
Secondary
Product Acceptability and Preference Questionnaire - Severity of Itching at Weeks 1 and 2
Product Acceptability and Preference Questionnaire were completed by the subject at each timepoint using the following scale: 0, None; 1, Very minimal; 2, Mild; 3, Moderate; 4, Severe.
Time frame: Weeks 1 and 2
Population: ITT
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Clindoxyl Gel | Product Acceptability and Preference Questionnaire - Severity of Itching at Weeks 1 and 2 | Week 1 | 0.64 Units on a scale | Standard Deviation 1.11 |
| Clindoxyl Gel | Product Acceptability and Preference Questionnaire - Severity of Itching at Weeks 1 and 2 | Week 2 | 0.72 Units on a scale | Standard Deviation 0.96 |
| Epiduo Gel | Product Acceptability and Preference Questionnaire - Severity of Itching at Weeks 1 and 2 | Week 1 | 1.02 Units on a scale | Standard Deviation 1.34 |
| Epiduo Gel | Product Acceptability and Preference Questionnaire - Severity of Itching at Weeks 1 and 2 | Week 2 | 0.93 Units on a scale | Standard Deviation 1 |
Secondary
Product Acceptability and Preference Questionnaire - Severity of Redness at Week 8
Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 0, None; 1, Very minimal; 2, Mild; 3, Moderate; 4, Severe.
Time frame: Week 8
Population: ITT
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Clindoxyl Gel | Product Acceptability and Preference Questionnaire - Severity of Redness at Week 8 | 0.77 Units on a scale | Standard Deviation 1.09 |
Secondary
Product Acceptability and Preference Questionnaire - Severity of Redness at Weeks 1 and 2
Product Acceptability and Preference Questionnaire were completed by the subject at each timepoint using the following scale: 0, None; 1, Very minimal; 2, Mild; 3, Moderate; 4, Severe.
Time frame: Weeks 1 and 2
Population: ITT
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Clindoxyl Gel | Product Acceptability and Preference Questionnaire - Severity of Redness at Weeks 1 and 2 | Week 1 | 1.09 Units on a scale | Standard Deviation 1.18 |
| Clindoxyl Gel | Product Acceptability and Preference Questionnaire - Severity of Redness at Weeks 1 and 2 | Week 2 | 0.72 Units on a scale | Standard Deviation 0.86 |
| Epiduo Gel | Product Acceptability and Preference Questionnaire - Severity of Redness at Weeks 1 and 2 | Week 1 | 1.72 Units on a scale | Standard Deviation 1.21 |
| Epiduo Gel | Product Acceptability and Preference Questionnaire - Severity of Redness at Weeks 1 and 2 | Week 2 | 1.15 Units on a scale | Standard Deviation 1.07 |
Secondary
Product Acceptability and Preference Questionnaire - Severity of Scaling at Week 8
Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 0, None; 1, Very minimal; 2, Mild; 3, Moderate; 4, Severe; 5, Very Severe.
Time frame: Week 8
Population: ITT
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Clindoxyl Gel | Product Acceptability and Preference Questionnaire - Severity of Scaling at Week 8 | 0.45 Units on a scale | Standard Deviation 0.83 |
Secondary
Product Acceptability and Preference Questionnaire - Severity of Scaling at Weeks 1 and 2
Product Acceptability and Preference Questionnaire were completed by the subject at each timepoint using the following scale: 0, None; 1, Very minimal; 2, Mild; 3, Moderate; 4, Severe; 5, Very Severe.
Time frame: Weeks 1 and 2
Population: ITT
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Clindoxyl Gel | Product Acceptability and Preference Questionnaire - Severity of Scaling at Weeks 1 and 2 | Week 1 | 0.79 Units on a scale | Standard Deviation 1.18 |
| Clindoxyl Gel | Product Acceptability and Preference Questionnaire - Severity of Scaling at Weeks 1 and 2 | Week 2 | 0.59 Units on a scale | Standard Deviation 0.69 |
| Epiduo Gel | Product Acceptability and Preference Questionnaire - Severity of Scaling at Weeks 1 and 2 | Week 1 | 1.43 Units on a scale | Standard Deviation 1.41 |
| Epiduo Gel | Product Acceptability and Preference Questionnaire - Severity of Scaling at Weeks 1 and 2 | Week 2 | 1.04 Units on a scale | Standard Deviation 1.07 |
Secondary
Product Acceptability and Preference Questionnaire - Use of Study Product if Choice to Continue Acne Treatment at Week 1 and 2
Product Acceptability and Preference Questionnaire were completed by the subject at each timepoint by answering Yes or No to the following question: If you were to choose to continue treatment for your acne, would you use the study product?
Time frame: Weeks 1 and 2
Population: ITT
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Clindoxyl Gel | Product Acceptability and Preference Questionnaire - Use of Study Product if Choice to Continue Acne Treatment at Week 1 and 2 | Week 1 - Yes | 44 Participants |
| Clindoxyl Gel | Product Acceptability and Preference Questionnaire - Use of Study Product if Choice to Continue Acne Treatment at Week 1 and 2 | Week 1 - No | 3 Participants |
| Clindoxyl Gel | Product Acceptability and Preference Questionnaire - Use of Study Product if Choice to Continue Acne Treatment at Week 1 and 2 | Week 2 - Yes | 39 Participants |
| Clindoxyl Gel | Product Acceptability and Preference Questionnaire - Use of Study Product if Choice to Continue Acne Treatment at Week 1 and 2 | Week 2 - No | 7 Participants |
| Epiduo Gel | Product Acceptability and Preference Questionnaire - Use of Study Product if Choice to Continue Acne Treatment at Week 1 and 2 | Week 2 - No | 14 Participants |
| Epiduo Gel | Product Acceptability and Preference Questionnaire - Use of Study Product if Choice to Continue Acne Treatment at Week 1 and 2 | Week 1 - Yes | 26 Participants |
| Epiduo Gel | Product Acceptability and Preference Questionnaire - Use of Study Product if Choice to Continue Acne Treatment at Week 1 and 2 | Week 2 - Yes | 32 Participants |
| Epiduo Gel | Product Acceptability and Preference Questionnaire - Use of Study Product if Choice to Continue Acne Treatment at Week 1 and 2 | Week 1 - No | 21 Participants |
Secondary
Product Acceptability and Preference Questionnaire - Use of Study Product if Choice to Continue Acne Treatment at Week 8
Product Acceptability and Preference Questionnaire were completed by the subject at 8 week timepoint by answering Yes or No to the following question: If you were to choose to continue treatment for your acne, would you use the study product?
Time frame: Week 8
Population: ITT
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Clindoxyl Gel | Product Acceptability and Preference Questionnaire - Use of Study Product if Choice to Continue Acne Treatment at Week 8 | Yes | 41 Participants |
| Clindoxyl Gel | Product Acceptability and Preference Questionnaire - Use of Study Product if Choice to Continue Acne Treatment at Week 8 | No | 5 Participants |
Secondary
Product Acceptability and Preference Questionnaire - Which Study Product is Subject More Satisfied With? at Weeks 1 and 2
Product Acceptability and Preference Questionnaire were completed by the subject at each timepoint using the following choices: Epiduo, Clindoxyl Gel, Both Treatments Equally.
Time frame: Weeks 1 and 2
Population: ITT. Data are presented for only those participants completing the questionnaire.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Clindoxyl Gel | Product Acceptability and Preference Questionnaire - Which Study Product is Subject More Satisfied With? at Weeks 1 and 2 | Week 2, Clindoxyl Gel, n=46 | 29 Participants |
| Clindoxyl Gel | Product Acceptability and Preference Questionnaire - Which Study Product is Subject More Satisfied With? at Weeks 1 and 2 | Week 2, Both Treatments Equally, n=46 | 1 Participants |
| Clindoxyl Gel | Product Acceptability and Preference Questionnaire - Which Study Product is Subject More Satisfied With? at Weeks 1 and 2 | Week 1, Epiduo Gel, n=47 | 15 Participants |
| Clindoxyl Gel | Product Acceptability and Preference Questionnaire - Which Study Product is Subject More Satisfied With? at Weeks 1 and 2 | Week 1, Clindoxyl Gel, n=47 | 30 Participants |
| Clindoxyl Gel | Product Acceptability and Preference Questionnaire - Which Study Product is Subject More Satisfied With? at Weeks 1 and 2 | Week 1, Both Treatments Equally, n=47 | 2 Participants |
| Clindoxyl Gel | Product Acceptability and Preference Questionnaire - Which Study Product is Subject More Satisfied With? at Weeks 1 and 2 | Week 2, Epiduo Gel, n=46 | 16 Participants |
Secondary
Quality of Life Questionnaire - Emotional Domain
Skindex-29 is a self-administered (by participants at each time point) QoL questionnaire comprised of 29 items (it.) scored on a 5-point scale (0=never, 1=rarely, 2=sometimes, 3=often, 4=all the time) covering 3 domains: emotional (10 it.); symptomatic (7 it.); functional (12 it.). Domain scores range from 0 to 40, 0 to 28, and 0 to 48, respectively. Lower scores=better QoL. The emotional score (score=0 to 40)=(sum of the 10 individual item scores) \* 100/40.
Time frame: Baseline, Weeks 2 and 8
Population: ITT
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Clindoxyl Gel | Quality of Life Questionnaire - Emotional Domain | Baseline | 25.32 Units on a scale | Standard Deviation 19.73 |
| Clindoxyl Gel | Quality of Life Questionnaire - Emotional Domain | Week 2 | 19.38 Units on a scale | Standard Deviation 18.68 |
| Clindoxyl Gel | Quality of Life Questionnaire - Emotional Domain | Week 8 | 16.42 Units on a scale | Standard Deviation 19.08 |
Secondary
Quality of Life Questionnaire - Functional Domain
Skindex-29 is a self-administered (by participants at each time point) QoL questionnaire comprised of 29 items (it.) scored on a 5-point scale (0=never, 1=rarely, 2=sometimes, 3=often, 4=all the time) covering 3 domains: emotional (10 it.); symptomatic (7 it.); functional (12 it.). Domain scores range from 0 to 40, 0 to 28, and 0 to 48, respectively. Lower scores=better QoL. The functional score (score=0 to 48)=(sum of the 12 individual item scores) \* 100/48.
Time frame: Baseline, Weeks 2 and 8
Population: ITT
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Clindoxyl Gel | Quality of Life Questionnaire - Functional Domain | Baseline | 8.59 Units on a scale | Standard Deviation 13.98 |
| Clindoxyl Gel | Quality of Life Questionnaire - Functional Domain | Week 2 | 6.30 Units on a scale | Standard Deviation 11.77 |
| Clindoxyl Gel | Quality of Life Questionnaire - Functional Domain | Week 8 | 5.19 Units on a scale | Standard Deviation 11.78 |
Secondary
Quality of Life Questionnaire - Global Score
Skindex-29 is a self-administered (by participants at each time point) QoL questionnaire comprised of 29 items (it.) scored on a 5-point scale (0=never, 1=rarely, 2=sometimes, 3=often, 4=all the time) covering 3 domains: emotional (10 it.); symptomatic (7 it.); functional (12 it.). Domain scores range from 0 to 40, 0 to 28, and 0 to 48, respectively. Lower scores=better QoL. A Global Score (range 0-100)=(sum of all 29 individual item scores) \* 100/116.
Time frame: Baseline, Weeks 2 and 8
Population: ITT
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Clindoxyl Gel | Quality of Life Questionnaire - Global Score | Baseline | 8.59 Units on a scale | Standard Deviation 13.98 |
| Clindoxyl Gel | Quality of Life Questionnaire - Global Score | Week 2 | 6.30 Units on a scale | Standard Deviation 11.77 |
| Clindoxyl Gel | Quality of Life Questionnaire - Global Score | Week 8 | 5.19 Units on a scale | Standard Deviation 11.78 |
Secondary
Skindex-29 Quality of Life Questionnaire (QoL) - Symptomatic Domain
Skindex-29 is a self-administered (by participants at each time point) QoL questionnaire comprised of 29 items (it.) scored on a 5-point scale (0=never, 1=rarely, 2=sometimes, 3=often, 4=all the time) covering 3 domains: emotional (10 it.); symptomatic (7 it.); functional (12 it.). Domain scores range from 0 to 40, 0 to 28, and 0 to 48, respectively. Lower scores=better QoL. The symptomatic score (score=0 to 28)=(sum of the 7 individual item scores) \* 100/28.
Time frame: Baseline, Weeks 2 and 8
Population: ITT
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Clindoxyl Gel | Skindex-29 Quality of Life Questionnaire (QoL) - Symptomatic Domain | Baseline | 20.91 Units on a scale | Standard Deviation 15.73 |
| Clindoxyl Gel | Skindex-29 Quality of Life Questionnaire (QoL) - Symptomatic Domain | Week 2 | 21.58 Units on a scale | Standard Deviation 14.17 |
| Clindoxyl Gel | Skindex-29 Quality of Life Questionnaire (QoL) - Symptomatic Domain | Week 8 | 13.75 Units on a scale | Standard Deviation 14.03 |
Secondary
Skin Dryness
Signs and symptoms of tolerability (erythema, peeling, dryness, and irritant/allergic contact dermatitis)on the face. Erythema, peeling, dryness, and irritant/allergic contact dermatitis were graded using the following scale: 0, None; 1, Slight; 2, Moderate; 3, Intense.
Time frame: Weeks 5 and 8
Population: ITT
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Clindoxyl Gel | Skin Dryness | Week 5 | 0.20 units on a scale | Standard Deviation 0.46 |
| Clindoxyl Gel | Skin Dryness | Week 8 | 0.04 units on a scale | Standard Deviation 0.29 |
Secondary
Skin Peeling
Signs and symptoms of tolerability (erythema, peeling, dryness, and irritant/allergic contact dermatitis)on the face. Erythema, peeling, dryness, and irritant/allergic contact dermatitis were graded using the following scale: 0, None; 1, Slight; 2, Moderate; 3, Intense.
Time frame: Weeks 5 and 8
Population: ITT
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Clindoxyl Gel | Skin Peeling | Week 5 | 0.13 units on a scale | Standard Deviation 0.4 |
| Clindoxyl Gel | Skin Peeling | Week 8 | 0.06 units on a scale | Standard Deviation 0.25 |
Secondary
Total Acne Lesion Counts
Total acne lesion counts - includes both inflammatory acne lesions (pustules, papules), noninflammatory lesions (whiteheads and blackheads),
Time frame: Baseline, Weeks 5 and 8
Population: ITT
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Clindoxyl Gel | Total Acne Lesion Counts | Baseline | 39.06 Acne Lesions | Standard Deviation 12.95 |
| Clindoxyl Gel | Total Acne Lesion Counts | Week 5 | 15.96 Acne Lesions | Standard Deviation 10.37 |
| Clindoxyl Gel | Total Acne Lesion Counts | Week 8 | 13.77 Acne Lesions | Standard Deviation 11.5 |