Acne Vulgaris
Conditions
Keywords
Acne, Irritation
Brief summary
This study is to see if there's any difference in the amount of facial irritation when two acne products are used together on one side of the face, compared to one acne treatment product used alone on the other side of the face. All people participating in this trial will be required to return to the same study center every weekday for two weeks for the investigator to check for irritation on the face and to have the products applied - on weekends they will have to put them on at home. If one side of the face is more irritated than the other side, a picture will be taken as well.
Detailed description
This is an investigator-blind, randomized, balanced study comparing two treatment regimens in a split-face model. All subjects will apply Retin-A Micro Gel (tretinoin) 0.1 % Pump, and Aczone Gel (dapsone) 5% daily to one side of the face (with 1 hour between applications, applying Aczone Gel first) and Retin-A Micro Gel 0.1 % Pump to the other side of the face in a randomized scheme for two consecutive weeks. Subjects will return to the study center daily for evaluation and for application of both products (weekend applications will be done at home). At each visit the subject will be evaluated and scored for irritation and cutaneous treatment effects. Subjects presenting with differences in irritation between one side of the face and the other will be photographed and have chromometer readings taken. A single treatment center is expected to enroll at least 24 subjects.
Interventions
DRUGDapsone plus Tretinoin Gel
Dapsone gel, followed by tretinoin gel one hour later, applied once daily to the assigned side of the face for 2 weeks
DRUGTretinoin Gel
Tretinoin gel applied once daily to the assigned side of the face for 2 weeks
Sponsors
Bausch Health Americas, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
* Fitzpatrick Skin Type I, II or III with healthy skin as judged by the investigator * Bilateral skin is clear of any confounding irritation, rashes, acne, rosacea, etc., prior to study start * Subjects are willing to avoid applying emollients or cosmetics to the face 24 hours before they start, and during the study * If subject is of childbearing potential, subject has been using a protocol-approved method of birth control for a certain amount of time, and is willing to continue using it throughout the study
Exclusion criteria
* Subjects who are pregnant or nursing, or intend to be during the study * Subjects with any condition or medical history, or using any drug or medication, that might negatively affect the subject's safety or the validity of study results, either as listed in the protocol or in the opinion of the investigator * Subjects who have facial hair that may obstruct or hinder the evaluation of any reactions * Subjects who use any known photosensitizing agents
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Expert Grader Assessment - Erythema | Baseline to 2 Weeks | Ordinal erythema scores (on a scale of 0=none to 8=severe scaling and fissuring) were collected on weekdays for two weeks and the total daily score (for all subjects) was treated as a single interval measurement for comparative assessment between treatment regimens. Thus, for the total for the 25 Participants measured, minimum possible score reported below is 0 and maximum is 2000 (highest possible score of 8, times 10 days, times 25 subjects). |
| Expert Grader Assessment - Dryness | Baseline to 2 Weeks | Ordinal dryness scores (on a scale of 0=none to 8=deep) were collected on weekdays for two weeks and the total daily score (for all subjects) was treated as a single interval measurement for comparative assessment between treatment regimens. Thus, for the total for the 25 Participants measured, minimum possible score reported below is 0 and maximum is 2000 (highest possible score of 8, times 10 days, times 25 subjects). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Subject Assessment - Burning/Stinging | Baseline to 2 Weeks | Ordinal burning/stinging scores (on a scale of 0=none to 3=severe) were collected on weekdays for two weeks and the total daily score (for all subjects) was treated as a single interval measurement for comparative assessment between treatment regimens. Thus, for the total for the 25 Participants measured, minimum possible score reported below is 0 and maximum is 750 (highest possible score of 3, times 10 days, times 25 subjects). |
| Subject Assessment - Itching | Baseline to 2 Weeks | Ordinal itching scores (on a scale of 0=none to 3=severe) were collected on weekdays for two weeks and the total daily score (for all subjects) was treated as a single interval measurement for comparative assessment between treatment regimens. Thus, for the total for the 25 Participants measured, minimum possible score reported below is 0 and maximum is 750 (highest possible score of 3, times 10 days, times 25 subjects). |
| Subject Assessment - Tightness | Baseline to 2 Weeks | Ordinal tightness scores (on a scale of 0=none to 3=severe) were collected on weekdays for two weeks and the total daily score (for all subjects) was treated as a single interval measurement for comparative assessment between treatment regimens. Thus, for the total for the 25 Participants measured, minimum possible score reported below is 0 and maximum is 750 (highest possible score of 3, times 10 days, times 25 subjects). |
| Facial Tolerance | Baseline to 2 Weeks | All interval measurements were combined for comparative assessment between treatment regimens. Facial tolerance is the sum of scores from Erythema, Dryness, Burning/Stinging, Itching, and Tightness assessments, reported in Outcome Measures 1-5. Thus, for the total for the 25 Participants measured, minimum possible score reported below is 0 and maximum is 6250 (highest possible combined score of 25, times 10 days, times 25 subjects). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Overall Study This was a single-group study with two treatment arms using a split-face model, i.e., all subjects received both interventions on opposite sides of the face. | 25 |
| Total | 25 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Informed Consent to Baseline | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Overall Study |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 25 Participants |
| Fitzpatrick Score Type I | 1 Participants |
| Fitzpatrick Score Type II | 10 Participants |
| Fitzpatrick Score Type III | 14 Participants |
| Region of Enrollment United States | 25 participants |
| Sex/Gender, Customized | 25 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 2 / 25 |
| serious Total, serious adverse events | 0 / 25 |
Outcome results
Primary
Expert Grader Assessment - Dryness
Ordinal dryness scores (on a scale of 0=none to 8=deep) were collected on weekdays for two weeks and the total daily score (for all subjects) was treated as a single interval measurement for comparative assessment between treatment regimens. Thus, for the total for the 25 Participants measured, minimum possible score reported below is 0 and maximum is 2000 (highest possible score of 8, times 10 days, times 25 subjects).
Time frame: Baseline to 2 Weeks
Population: Intention to Treat (ITT)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dapsone Gel + Tretinoin Gel | Expert Grader Assessment - Dryness | Day 9 | 13.6 Scores on a Scale |
| Dapsone Gel + Tretinoin Gel | Expert Grader Assessment - Dryness | Day 14 | 23.5 Scores on a Scale |
| Dapsone Gel + Tretinoin Gel | Expert Grader Assessment - Dryness | Day 8 | 18.5 Scores on a Scale |
| Dapsone Gel + Tretinoin Gel | Expert Grader Assessment - Dryness | Day 10 | 20.4 Scores on a Scale |
| Dapsone Gel + Tretinoin Gel | Expert Grader Assessment - Dryness | Day 0 = Baseline | 0.0 Scores on a Scale |
| Dapsone Gel + Tretinoin Gel | Expert Grader Assessment - Dryness | Day 7 | 14.8 Scores on a Scale |
| Dapsone Gel + Tretinoin Gel | Expert Grader Assessment - Dryness | Day 1 | 0.6 Scores on a Scale |
| Dapsone Gel + Tretinoin Gel | Expert Grader Assessment - Dryness | Day 2 | 1.7 Scores on a Scale |
| Dapsone Gel + Tretinoin Gel | Expert Grader Assessment - Dryness | Day 11 | 17.3 Scores on a Scale |
| Dapsone Gel + Tretinoin Gel | Expert Grader Assessment - Dryness | Day 3 | 3.5 Scores on a Scale |
| Dapsone Gel + Tretinoin Gel | Expert Grader Assessment - Dryness | Day 4 | 12.6 Scores on a Scale |
| Tretinoin Gel Alone | Expert Grader Assessment - Dryness | Day 3 | 8.1 Scores on a Scale |
| Tretinoin Gel Alone | Expert Grader Assessment - Dryness | Day 4 | 14.2 Scores on a Scale |
| Tretinoin Gel Alone | Expert Grader Assessment - Dryness | Day 7 | 19.9 Scores on a Scale |
| Tretinoin Gel Alone | Expert Grader Assessment - Dryness | Day 8 | 25.6 Scores on a Scale |
| Tretinoin Gel Alone | Expert Grader Assessment - Dryness | Day 9 | 23.0 Scores on a Scale |
| Tretinoin Gel Alone | Expert Grader Assessment - Dryness | Day 10 | 37.6 Scores on a Scale |
| Tretinoin Gel Alone | Expert Grader Assessment - Dryness | Day 11 | 37.6 Scores on a Scale |
| Tretinoin Gel Alone | Expert Grader Assessment - Dryness | Day 14 | 28.3 Scores on a Scale |
| Tretinoin Gel Alone | Expert Grader Assessment - Dryness | Day 1 | 1.8 Scores on a Scale |
| Tretinoin Gel Alone | Expert Grader Assessment - Dryness | Day 0 = Baseline | 0.0 Scores on a Scale |
| Tretinoin Gel Alone | Expert Grader Assessment - Dryness | Day 2 | 2.5 Scores on a Scale |
Primary
Expert Grader Assessment - Erythema
Ordinal erythema scores (on a scale of 0=none to 8=severe scaling and fissuring) were collected on weekdays for two weeks and the total daily score (for all subjects) was treated as a single interval measurement for comparative assessment between treatment regimens. Thus, for the total for the 25 Participants measured, minimum possible score reported below is 0 and maximum is 2000 (highest possible score of 8, times 10 days, times 25 subjects).
Time frame: Baseline to 2 Weeks
Population: Intention to Treat (ITT)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dapsone Gel + Tretinoin Gel | Expert Grader Assessment - Erythema | Day 7 | 9.7 Scores on a Scale |
| Dapsone Gel + Tretinoin Gel | Expert Grader Assessment - Erythema | Day 1 | 0.4 Scores on a Scale |
| Dapsone Gel + Tretinoin Gel | Expert Grader Assessment - Erythema | Day 8 | 10.8 Scores on a Scale |
| Dapsone Gel + Tretinoin Gel | Expert Grader Assessment - Erythema | Day 3 | 1.6 Scores on a Scale |
| Dapsone Gel + Tretinoin Gel | Expert Grader Assessment - Erythema | Day 9 | 10.6 Scores on a Scale |
| Dapsone Gel + Tretinoin Gel | Expert Grader Assessment - Erythema | Day 10 | 11.6 Scores on a Scale |
| Dapsone Gel + Tretinoin Gel | Expert Grader Assessment - Erythema | Day 0 = Baseline | 0.0 Scores on a Scale |
| Dapsone Gel + Tretinoin Gel | Expert Grader Assessment - Erythema | Day 11 | 11.6 Scores on a Scale |
| Dapsone Gel + Tretinoin Gel | Expert Grader Assessment - Erythema | Day 4 | 6.8 Scores on a Scale |
| Dapsone Gel + Tretinoin Gel | Expert Grader Assessment - Erythema | Day 14 | 16.6 Scores on a Scale |
| Dapsone Gel + Tretinoin Gel | Expert Grader Assessment - Erythema | Day 2 | 0.4 Scores on a Scale |
| Tretinoin Gel Alone | Expert Grader Assessment - Erythema | Day 14 | 19.5 Scores on a Scale |
| Tretinoin Gel Alone | Expert Grader Assessment - Erythema | Day 0 = Baseline | 0.0 Scores on a Scale |
| Tretinoin Gel Alone | Expert Grader Assessment - Erythema | Day 1 | 2.0 Scores on a Scale |
| Tretinoin Gel Alone | Expert Grader Assessment - Erythema | Day 2 | 2.0 Scores on a Scale |
| Tretinoin Gel Alone | Expert Grader Assessment - Erythema | Day 3 | 6.4 Scores on a Scale |
| Tretinoin Gel Alone | Expert Grader Assessment - Erythema | Day 4 | 7.6 Scores on a Scale |
| Tretinoin Gel Alone | Expert Grader Assessment - Erythema | Day 7 | 17.1 Scores on a Scale |
| Tretinoin Gel Alone | Expert Grader Assessment - Erythema | Day 8 | 20.9 Scores on a Scale |
| Tretinoin Gel Alone | Expert Grader Assessment - Erythema | Day 10 | 20.4 Scores on a Scale |
| Tretinoin Gel Alone | Expert Grader Assessment - Erythema | Day 11 | 23.0 Scores on a Scale |
| Tretinoin Gel Alone | Expert Grader Assessment - Erythema | Day 9 | 20.1 Scores on a Scale |
Secondary
Facial Tolerance
All interval measurements were combined for comparative assessment between treatment regimens. Facial tolerance is the sum of scores from Erythema, Dryness, Burning/Stinging, Itching, and Tightness assessments, reported in Outcome Measures 1-5. Thus, for the total for the 25 Participants measured, minimum possible score reported below is 0 and maximum is 6250 (highest possible combined score of 25, times 10 days, times 25 subjects).
Time frame: Baseline to 2 Weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dapsone Gel + Tretinoin Gel | Facial Tolerance | Day 8 | 61.9 Scores on a Scale |
| Dapsone Gel + Tretinoin Gel | Facial Tolerance | Day 0 = Baseline | 1.0 Scores on a Scale |
| Dapsone Gel + Tretinoin Gel | Facial Tolerance | Day 10 | 63.7 Scores on a Scale |
| Dapsone Gel + Tretinoin Gel | Facial Tolerance | Day 1 | 6.7 Scores on a Scale |
| Dapsone Gel + Tretinoin Gel | Facial Tolerance | Day 9 | 51.0 Scores on a Scale |
| Dapsone Gel + Tretinoin Gel | Facial Tolerance | Day 2 | 5.9 Scores on a Scale |
| Dapsone Gel + Tretinoin Gel | Facial Tolerance | Day 11 | 57.7 Scores on a Scale |
| Dapsone Gel + Tretinoin Gel | Facial Tolerance | Day 3 | 14.9 Scores on a Scale |
| Dapsone Gel + Tretinoin Gel | Facial Tolerance | Day 7 | 44.2 Scores on a Scale |
| Dapsone Gel + Tretinoin Gel | Facial Tolerance | Day 4 | 36.4 Scores on a Scale |
| Dapsone Gel + Tretinoin Gel | Facial Tolerance | Day 14 | 72.8 Scores on a Scale |
| Tretinoin Gel Alone | Facial Tolerance | Day 4 | 45.3 Scores on a Scale |
| Tretinoin Gel Alone | Facial Tolerance | Day 8 | 95.1 Scores on a Scale |
| Tretinoin Gel Alone | Facial Tolerance | Day 9 | 93.9 Scores on a Scale |
| Tretinoin Gel Alone | Facial Tolerance | Day 10 | 124.6 Scores on a Scale |
| Tretinoin Gel Alone | Facial Tolerance | Day 11 | 115.2 Scores on a Scale |
| Tretinoin Gel Alone | Facial Tolerance | Day 14 | 94.8 Scores on a Scale |
| Tretinoin Gel Alone | Facial Tolerance | Day 0 = Baseline | 0.0 Scores on a Scale |
| Tretinoin Gel Alone | Facial Tolerance | Day 1 | 10.0 Scores on a Scale |
| Tretinoin Gel Alone | Facial Tolerance | Day 2 | 11.9 Scores on a Scale |
| Tretinoin Gel Alone | Facial Tolerance | Day 3 | 26.5 Scores on a Scale |
| Tretinoin Gel Alone | Facial Tolerance | Day 7 | 66.6 Scores on a Scale |
Secondary
Subject Assessment - Burning/Stinging
Ordinal burning/stinging scores (on a scale of 0=none to 3=severe) were collected on weekdays for two weeks and the total daily score (for all subjects) was treated as a single interval measurement for comparative assessment between treatment regimens. Thus, for the total for the 25 Participants measured, minimum possible score reported below is 0 and maximum is 750 (highest possible score of 3, times 10 days, times 25 subjects).
Time frame: Baseline to 2 Weeks
Population: Intention to Treat (ITT)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dapsone Gel + Tretinoin Gel | Subject Assessment - Burning/Stinging | Day 3 | 6.6 Scores on a Scale |
| Dapsone Gel + Tretinoin Gel | Subject Assessment - Burning/Stinging | Day 8 | 14.5 Scores on a Scale |
| Dapsone Gel + Tretinoin Gel | Subject Assessment - Burning/Stinging | Day 2 | 1.8 Scores on a Scale |
| Dapsone Gel + Tretinoin Gel | Subject Assessment - Burning/Stinging | Day 9 | 9.6 Scores on a Scale |
| Dapsone Gel + Tretinoin Gel | Subject Assessment - Burning/Stinging | Day 4 | 8.7 Scores on a Scale |
| Dapsone Gel + Tretinoin Gel | Subject Assessment - Burning/Stinging | Day 10 | 11.6 Scores on a Scale |
| Dapsone Gel + Tretinoin Gel | Subject Assessment - Burning/Stinging | Day 1 | 2.6 Scores on a Scale |
| Dapsone Gel + Tretinoin Gel | Subject Assessment - Burning/Stinging | Day 11 | 10.6 Scores on a Scale |
| Dapsone Gel + Tretinoin Gel | Subject Assessment - Burning/Stinging | Day 7 | 7.5 Scores on a Scale |
| Dapsone Gel + Tretinoin Gel | Subject Assessment - Burning/Stinging | Day 14 | 14.6 Scores on a Scale |
| Dapsone Gel + Tretinoin Gel | Subject Assessment - Burning/Stinging | Day 0 = Baseline | 1.0 Scores on a Scale |
| Tretinoin Gel Alone | Subject Assessment - Burning/Stinging | Day 14 | 23.2 Scores on a Scale |
| Tretinoin Gel Alone | Subject Assessment - Burning/Stinging | Day 0 = Baseline | 0.0 Scores on a Scale |
| Tretinoin Gel Alone | Subject Assessment - Burning/Stinging | Day 1 | 1.6 Scores on a Scale |
| Tretinoin Gel Alone | Subject Assessment - Burning/Stinging | Day 2 | 2.6 Scores on a Scale |
| Tretinoin Gel Alone | Subject Assessment - Burning/Stinging | Day 3 | 5.5 Scores on a Scale |
| Tretinoin Gel Alone | Subject Assessment - Burning/Stinging | Day 4 | 12.2 Scores on a Scale |
| Tretinoin Gel Alone | Subject Assessment - Burning/Stinging | Day 7 | 9.5 Scores on a Scale |
| Tretinoin Gel Alone | Subject Assessment - Burning/Stinging | Day 8 | 17.2 Scores on a Scale |
| Tretinoin Gel Alone | Subject Assessment - Burning/Stinging | Day 9 | 20.2 Scores on a Scale |
| Tretinoin Gel Alone | Subject Assessment - Burning/Stinging | Day 10 | 25.9 Scores on a Scale |
| Tretinoin Gel Alone | Subject Assessment - Burning/Stinging | Day 11 | 25.9 Scores on a Scale |
Secondary
Subject Assessment - Itching
Ordinal itching scores (on a scale of 0=none to 3=severe) were collected on weekdays for two weeks and the total daily score (for all subjects) was treated as a single interval measurement for comparative assessment between treatment regimens. Thus, for the total for the 25 Participants measured, minimum possible score reported below is 0 and maximum is 750 (highest possible score of 3, times 10 days, times 25 subjects).
Time frame: Baseline to 2 Weeks
Population: Intention to Treat (ITT)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dapsone Gel + Tretinoin Gel | Subject Assessment - Itching | Day 3 | 0.6 Scores on a Scale |
| Dapsone Gel + Tretinoin Gel | Subject Assessment - Itching | Day 8 | 5.6 Scores on a Scale |
| Dapsone Gel + Tretinoin Gel | Subject Assessment - Itching | Day 2 | 0.5 Scores on a Scale |
| Dapsone Gel + Tretinoin Gel | Subject Assessment - Itching | Day 9 | 5.6 Scores on a Scale |
| Dapsone Gel + Tretinoin Gel | Subject Assessment - Itching | Day 4 | 2.6 Scores on a Scale |
| Dapsone Gel + Tretinoin Gel | Subject Assessment - Itching | Day 10 | 7.6 Scores on a Scale |
| Dapsone Gel + Tretinoin Gel | Subject Assessment - Itching | Day 1 | 1.6 Scores on a Scale |
| Dapsone Gel + Tretinoin Gel | Subject Assessment - Itching | Day 11 | 8.6 Scores on a Scale |
| Dapsone Gel + Tretinoin Gel | Subject Assessment - Itching | Day 7 | 3.6 Scores on a Scale |
| Dapsone Gel + Tretinoin Gel | Subject Assessment - Itching | Day 14 | 7.6 Scores on a Scale |
| Dapsone Gel + Tretinoin Gel | Subject Assessment - Itching | Day 0 = Baseline | 0.0 Scores on a Scale |
| Tretinoin Gel Alone | Subject Assessment - Itching | Day 14 | 9.4 Scores on a Scale |
| Tretinoin Gel Alone | Subject Assessment - Itching | Day 0 = Baseline | 0.0 Scores on a Scale |
| Tretinoin Gel Alone | Subject Assessment - Itching | Day 1 | 2.8 Scores on a Scale |
| Tretinoin Gel Alone | Subject Assessment - Itching | Day 2 | 1.9 Scores on a Scale |
| Tretinoin Gel Alone | Subject Assessment - Itching | Day 3 | 1.8 Scores on a Scale |
| Tretinoin Gel Alone | Subject Assessment - Itching | Day 4 | 2.8 Scores on a Scale |
| Tretinoin Gel Alone | Subject Assessment - Itching | Day 7 | 7.6 Scores on a Scale |
| Tretinoin Gel Alone | Subject Assessment - Itching | Day 8 | 12.4 Scores on a Scale |
| Tretinoin Gel Alone | Subject Assessment - Itching | Day 9 | 12.4 Scores on a Scale |
| Tretinoin Gel Alone | Subject Assessment - Itching | Day 10 | 17.1 Scores on a Scale |
| Tretinoin Gel Alone | Subject Assessment - Itching | Day 11 | 13.4 Scores on a Scale |
Secondary
Subject Assessment - Tightness
Ordinal tightness scores (on a scale of 0=none to 3=severe) were collected on weekdays for two weeks and the total daily score (for all subjects) was treated as a single interval measurement for comparative assessment between treatment regimens. Thus, for the total for the 25 Participants measured, minimum possible score reported below is 0 and maximum is 750 (highest possible score of 3, times 10 days, times 25 subjects).
Time frame: Baseline to 2 Weeks
Population: Intention to Treat (ITT)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dapsone Gel + Tretinoin Gel | Subject Assessment - Tightness | Day 3 | 2.6 Scores on a Scale |
| Dapsone Gel + Tretinoin Gel | Subject Assessment - Tightness | Day 8 | 12.5 Scores on a Scale |
| Dapsone Gel + Tretinoin Gel | Subject Assessment - Tightness | Day 2 | 1.5 Scores on a Scale |
| Dapsone Gel + Tretinoin Gel | Subject Assessment - Tightness | Day 9 | 11.6 Scores on a Scale |
| Dapsone Gel + Tretinoin Gel | Subject Assessment - Tightness | Day 4 | 5.7 Scores on a Scale |
| Dapsone Gel + Tretinoin Gel | Subject Assessment - Tightness | Day 10 | 12.5 Scores on a Scale |
| Dapsone Gel + Tretinoin Gel | Subject Assessment - Tightness | Day 1 | 1.5 Scores on a Scale |
| Dapsone Gel + Tretinoin Gel | Subject Assessment - Tightness | Day 11 | 9.6 Scores on a Scale |
| Dapsone Gel + Tretinoin Gel | Subject Assessment - Tightness | Day 7 | 8.6 Scores on a Scale |
| Dapsone Gel + Tretinoin Gel | Subject Assessment - Tightness | Day 14 | 10.5 Scores on a Scale |
| Dapsone Gel + Tretinoin Gel | Subject Assessment - Tightness | Day 0 = Baseline | 0.0 Scores on a Scale |
| Tretinoin Gel Alone | Subject Assessment - Tightness | Day 14 | 14.4 Scores on a Scale |
| Tretinoin Gel Alone | Subject Assessment - Tightness | Day 0 = Baseline | 0.0 Scores on a Scale |
| Tretinoin Gel Alone | Subject Assessment - Tightness | Day 1 | 1.8 Scores on a Scale |
| Tretinoin Gel Alone | Subject Assessment - Tightness | Day 2 | 2.9 Scores on a Scale |
| Tretinoin Gel Alone | Subject Assessment - Tightness | Day 3 | 4.7 Scores on a Scale |
| Tretinoin Gel Alone | Subject Assessment - Tightness | Day 4 | 8.5 Scores on a Scale |
| Tretinoin Gel Alone | Subject Assessment - Tightness | Day 7 | 12.5 Scores on a Scale |
| Tretinoin Gel Alone | Subject Assessment - Tightness | Day 8 | 19.0 Scores on a Scale |
| Tretinoin Gel Alone | Subject Assessment - Tightness | Day 9 | 17.2 Scores on a Scale |
| Tretinoin Gel Alone | Subject Assessment - Tightness | Day 10 | 20.0 Scores on a Scale |
| Tretinoin Gel Alone | Subject Assessment - Tightness | Day 11 | 15.3 Scores on a Scale |