Acne Rosacea
Conditions
Brief summary
The study evaluated the safety, tolerability, and efficacy of ACCU-D1 when applied twice daily for 12 weeks in adult participants with moderate to severe acne rosacea. Two-third of the participants received ACCU-D1 while one-third of the participants received vehicle control.
Interventions
DRUGACCU-D1
ACCU-D1
DRUGVehicle
Placebo Comparator
Sponsors
Accuitis, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participant is male or non-pregnant and non-lactating female at least 18 years of age * Participant has a clinical diagnosis of stable papulopustular rosacea (type-2) * Participant has a total of ≥10 and ≤40 inflammatory lesions (papules, pustules, and nodules) on the face * Participant has ≤2 nodules on the face * Participant has an investigator's global assessment (IGA) score of ≥3 * If the participant is a woman of childbearing potential, she has a negative urine pregnancy test and agrees to use an approved effective method of birth control for the duration of the study * Participant is in good general health and free of any known disease state or physical condition which, in the investigator's opinion, might impair evaluation of rosacea or which exposes the participant to an unacceptable risk by study participation * Participant is willing and able to follow all study instructions and to attend all study visits * Participant is able to comprehend and willing to sign an informed consent form
Exclusion criteria
* Participant is pregnant, nursing, or planning to become pregnant during the duration of the study * Participant has used systemic glucocorticosteroids within 42 days prior to Visit 1 (inhaled and ocular glucocorticosteroids are permitted) * Participant has used systemic antibiotics within 28 days prior to Visit 1 * Participant has used any topical glucocorticosteroids on the face within 28 days prior to Visit 1 * Participant has used any prescription or over-the-counter product for the treatment of acne or rosacea within 14 days prior to Visit 1 * Participant is currently using any therapy that, in the investigator's opinion, is a photosensitizer (for example, phenothiazines, amiodarone, quinine, thiazides, sulphonamides, quinolones, etc.) * Participant currently has any skin disease (for example, psoriasis, atopic dermatitis, eczema), or condition (for example, actinic keratosis, photo-damage, sunburn, excessive hair, open wounds) that, in the investigator's opinion, might impair evaluation of rosacea or which exposes the subject to an unacceptable risk by study participation * Participant currently has, on the face, or has had on the face, any of the following within the specified period prior to Visit 1 that, in the investigator's opinion, might impair evaluation of rosacea or which exposes the subject to an unacceptable risk by study participation: * A cutaneous malignancy; 180 days * Experienced a sunburn; 14 days * Participant has facial hair, that in the investigator's opinion, might impair evaluation of rosacea or proper study medication application * Participant has a history of sensitivity to any of the ingredients in the study medications * Participant has participated in an investigational drug trial in which administration of an investigational study medication occurred within 30 days prior to Visit 1
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Total Lesion Count at Week 12 | Baseline, Week 12 | Total lesion count was the sum of counts of the following lesion types (face only): Papule - raised inflammatory lesions, \<0.5 cm in diameter with no visible purulent material; Pustule - raised inflammatory lesions, \<0.5 cm in diameter with visible purulent material; Nodule - any circumscribed, inflammatory mass ≥0.5 cm in diameter. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change From Baseline in Investigator's Global Assessment (IGA) Score at Weeks 2, 4, 8, and 12 | Baseline; Weeks 2, 4, 8, and 12 | The IGA score is an ordered categorical value ranging from 0 (clear) to 4 (severe). A lower score indicated improvement in the condition. Score 0 (clear): no papules or pustules, no nodules, none or barely perceptible erythema Score 1 (near clear): very few (≤3) papules and/or pustules, no nodules, very mild erythema Score 2 (mild): few papules and pustules present, no nodules, mild erythema Score 3 (moderate): several papules and pustules are the predominant features, ≤2 nodules may be present, moderate erythema Score 4 (severe): numerous papules and pustules, multiple nodules may be present, severe erythema |
| Percentage of Participants Who Were Treatment Responders at Week 12 | Baseline, Week 12 | Treatment responders were defined as participants who have either (1) 2 ordinal or more reductions in the IGA score from baseline or (2) an IGA score of 0 or 1. The IGA score is an ordered categorical value ranging from 0 (clear) to 4 (severe). A lower score indicated improvement in the condition. Score 0 (clear): no papules or pustules, no nodules, none or barely perceptible erythema Score 1 (near clear): very few (≤3) papules and/or pustules, no nodules, very mild erythema Score 2 (mild): few papules and pustules present, no nodules, mild erythema Score 3 (moderate): several papules and pustules are the predominant features, ≤2 nodules may be present, moderate erythema Score 4 (severe): numerous papules and pustules, multiple nodules may be present, severe erythema |
| Change From Baseline in Papule Lesions at Weeks 2, 4, 8, and 12 | Baseline; Weeks 2, 4, 8, and 12 | Papule - raised inflammatory lesions, \<0.5 cm in diameter with no visible purulent material |
| Change From Baseline in Pustule Lesions at Weeks 2, 4, 8, and 12 | Baseline; Weeks 2, 4, 8, and 12 | Pustule - raised inflammatory lesions, \<0.5 cm in diameter with visible purulent material |
| Change From Baseline in Papules + Pustules Lesions at Weeks 2, 4, 8, and 12 | Baseline; Weeks 2, 4, 8, and 12 | Papules + pustules lesions were the sum of counts of papule (raised inflammatory lesions, \<0.5 cm in diameter with no visible purulent material) and pustule (raised inflammatory lesions, \<0.5 cm in diameter with visible purulent material) lesions. |
| Number of Participants With Adverse Events | Baseline to Week 14 | Number of participants reporting any adverse event including local tolerability of signs and symptoms of irritation, clinical laboratory safety tests, and vital signs. |
| Change From Baseline in Nodule Lesions at Weeks 2, 4, 8, and 12 | Baseline; Weeks 2, 4, 8, and 12 | Nodule - any circumscribed, inflammatory mass ≥0.5 cm in diameter |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Erythema Score Based on Local Tolerability as Assessed by the Investigator at Week 12 | Week 12 | Erythema score was evaluated by the investigator on a 0 to 3 scale with a lower score indicating lesser severity. Score 0 (clear): no erythema present Score 1 (mild): slight erythema Score 2 (moderate): definite erythema Score 3 (severe): marked, fiery erythema |
| Number of Participants With Erythema Score Based on Local Tolerability as Assessed by the Investigator at Day 1 (Post-application) and Weeks 2, 4, 8, and 14 | Day 1 (Post-application) and Weeks 2, 4, 8, and 14 | Erythema score was evaluated by the investigator on a 0 to 3 scale with a lower score indicating lesser severity. Score 0 (clear): no erythema present Score 1 (mild): slight erythema Score 2 (moderate): definite erythema Score 3 (severe): marked, fiery erythema |
Countries
United States
Participant flow
Recruitment details
The study was conducted at two sites in the United States.
Pre-assignment details
Eligible participants will be assigned in a random manner to 1 of the 2 study medications in a 2:1 ratio (ACU-D1 ointment: ACU-D1 ointment vehicle).
Participants by arm
| Arm | Count |
|---|---|
| ACU-D1 Ointment Twice-daily application of ACU-D1 ointment to the face for 12 weeks. | 27 |
| ACU-D1 Ointment Vehicle Twice-daily application of ACU-D1 ointment vehicle to the face for 12 weeks. | 13 |
| Total | 40 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | ACU-D1 Ointment | Total | ACU-D1 Ointment Vehicle |
|---|---|---|---|
| Age, Continuous | 49.59 years STANDARD_DEVIATION 11.537 | 50.08 years STANDARD_DEVIATION 11.708 | 51.08 years STANDARD_DEVIATION 12.473 |
| Erythema score based on local tolerability as assessed by the investigator Score 0 (clear) | 1 Participants | 2 Participants | 1 Participants |
| Erythema score based on local tolerability as assessed by the investigator Score 1 (mild) | 5 Participants | 9 Participants | 4 Participants |
| Erythema score based on local tolerability as assessed by the investigator Score 2 (moderate) | 16 Participants | 21 Participants | 5 Participants |
| Erythema score based on local tolerability as assessed by the investigator Score 3 (severe) | 5 Participants | 8 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants | 5 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 22 Participants | 35 Participants | 13 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 27 Participants | 40 Participants | 13 Participants |
| Sex: Female, Male Female | 23 Participants | 34 Participants | 11 Participants |
| Sex: Female, Male Male | 4 Participants | 6 Participants | 2 Participants |
| Total lesion count | 18.00 number of lesions STANDARD_DEVIATION 9.413 | 18.80 number of lesions STANDARD_DEVIATION 9.479 | 20.46 number of lesions STANDARD_DEVIATION 9.777 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 27 | 0 / 13 |
| other Total, other adverse events | 11 / 27 | 4 / 13 |
| serious Total, serious adverse events | 0 / 27 | 0 / 13 |
Outcome results
Primary
Change From Baseline in Total Lesion Count at Week 12
Total lesion count was the sum of counts of the following lesion types (face only): Papule - raised inflammatory lesions, \<0.5 cm in diameter with no visible purulent material; Pustule - raised inflammatory lesions, \<0.5 cm in diameter with visible purulent material; Nodule - any circumscribed, inflammatory mass ≥0.5 cm in diameter.
Time frame: Baseline, Week 12
Population: Number of participants included participants in the MITT population with available data at Week 12.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| ACU-D1 Ointment | Change From Baseline in Total Lesion Count at Week 12 | -10.2 number of lesions | Standard Error 1.08 |
| ACU-D1 Ointment Vehicle | Change From Baseline in Total Lesion Count at Week 12 | -12.0 number of lesions | Standard Error 1.62 |
p-value: 0.36695% CI: [-2.162, 5.727]t-test, 2 sided
Secondary
Change From Baseline in Nodule Lesions at Weeks 2, 4, 8, and 12
Nodule - any circumscribed, inflammatory mass ≥0.5 cm in diameter
Time frame: Baseline; Weeks 2, 4, 8, and 12
Population: MITT population. Number of participants analyzed included participants with available data at specified visits.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| ACU-D1 Ointment | Change From Baseline in Nodule Lesions at Weeks 2, 4, 8, and 12 | Week 2 | 0.0 number of lesions | Standard Error 0.04 |
| ACU-D1 Ointment | Change From Baseline in Nodule Lesions at Weeks 2, 4, 8, and 12 | Week 8 | 0.0 number of lesions | Standard Error 0.04 |
| ACU-D1 Ointment | Change From Baseline in Nodule Lesions at Weeks 2, 4, 8, and 12 | Week 4 | 0.0 number of lesions | Standard Error 0.04 |
| ACU-D1 Ointment | Change From Baseline in Nodule Lesions at Weeks 2, 4, 8, and 12 | Week 12 | 0.0 number of lesions | Standard Error 0.04 |
| ACU-D1 Ointment Vehicle | Change From Baseline in Nodule Lesions at Weeks 2, 4, 8, and 12 | Week 12 | 0.04 number of lesions | Standard Error 0.06 |
| ACU-D1 Ointment Vehicle | Change From Baseline in Nodule Lesions at Weeks 2, 4, 8, and 12 | Week 2 | 0.02 number of lesions | Standard Error 0.06 |
| ACU-D1 Ointment Vehicle | Change From Baseline in Nodule Lesions at Weeks 2, 4, 8, and 12 | Week 4 | -0.05 number of lesions | Standard Error 0.06 |
| ACU-D1 Ointment Vehicle | Change From Baseline in Nodule Lesions at Weeks 2, 4, 8, and 12 | Week 8 | -0.05 number of lesions | Standard Error 0.06 |
Comparison: Change from baseline at Week 2p-value: 0.31395% CI: [-0.215, 0.069]t-test, 2 sided
Comparison: Change from baseline at Week 4p-value: 0.94295% CI: [-0.141, 0.152]t-test, 2 sided
Comparison: Change from baseline in nodule lesions at Week 8p-value: 0.28495% CI: [-0.067, 0.226]t-test, 2 sided
Comparison: Change from baseline at Week 12p-value: 0.54295% CI: [-0.198, 0.105]t-test, 2 sided
Secondary
Change From Baseline in Papule Lesions at Weeks 2, 4, 8, and 12
Papule - raised inflammatory lesions, \<0.5 cm in diameter with no visible purulent material
Time frame: Baseline; Weeks 2, 4, 8, and 12
Population: MITT population. Number of participants analyzed included participants with available data at specified visits.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| ACU-D1 Ointment | Change From Baseline in Papule Lesions at Weeks 2, 4, 8, and 12 | Week 2 | -6.6 number of lesions | Standard Error 1.09 |
| ACU-D1 Ointment | Change From Baseline in Papule Lesions at Weeks 2, 4, 8, and 12 | Week 4 | -9.7 number of lesions | Standard Error 0.97 |
| ACU-D1 Ointment | Change From Baseline in Papule Lesions at Weeks 2, 4, 8, and 12 | Week 8 | -8.1 number of lesions | Standard Error 1.16 |
| ACU-D1 Ointment | Change From Baseline in Papule Lesions at Weeks 2, 4, 8, and 12 | Week 12 | -9.2 number of lesions | Standard Error 1.01 |
| ACU-D1 Ointment Vehicle | Change From Baseline in Papule Lesions at Weeks 2, 4, 8, and 12 | Week 12 | -10.98 number of lesions | Standard Error 1.53 |
| ACU-D1 Ointment Vehicle | Change From Baseline in Papule Lesions at Weeks 2, 4, 8, and 12 | Week 2 | -7.95 number of lesions | Standard Error 1.57 |
| ACU-D1 Ointment Vehicle | Change From Baseline in Papule Lesions at Weeks 2, 4, 8, and 12 | Week 8 | -10.30 number of lesions | Standard Error 1.71 |
| ACU-D1 Ointment Vehicle | Change From Baseline in Papule Lesions at Weeks 2, 4, 8, and 12 | Week 4 | -8.22 number of lesions | Standard Error 1.44 |
Comparison: Change from baseline at Week 2p-value: 0.49595% CI: [-2.571, 5.211]t-test, 2 sided
Comparison: Change from baseline at Week 4p-value: 0.39995% CI: [-5.014, 2.045]t-test, 2 sided
Comparison: Change from baseline at Week 8p-value: 0.2995% CI: [-1.965, 6.407]t-test, 2 sided
Comparison: Change from baseline at Week 12p-value: 0.34395% CI: [-1.953, 5.469]t-test, 2 sided
Secondary
Change From Baseline in Papules + Pustules Lesions at Weeks 2, 4, 8, and 12
Papules + pustules lesions were the sum of counts of papule (raised inflammatory lesions, \<0.5 cm in diameter with no visible purulent material) and pustule (raised inflammatory lesions, \<0.5 cm in diameter with visible purulent material) lesions.
Time frame: Baseline; Weeks 2, 4, 8, and 12
Population: MITT population. Number of participants analyzed included participants with available data at specified visits.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| ACU-D1 Ointment | Change From Baseline in Papules + Pustules Lesions at Weeks 2, 4, 8, and 12 | Week 2 | -7.0 number of lesions | Standard Error 1.16 |
| ACU-D1 Ointment | Change From Baseline in Papules + Pustules Lesions at Weeks 2, 4, 8, and 12 | Week 4 | -10.9 number of lesions | Standard Error 1.06 |
| ACU-D1 Ointment | Change From Baseline in Papules + Pustules Lesions at Weeks 2, 4, 8, and 12 | Week 8 | -9.2 number of lesions | Standard Error 1.19 |
| ACU-D1 Ointment | Change From Baseline in Papules + Pustules Lesions at Weeks 2, 4, 8, and 12 | Week 12 | -10.2 number of lesions | Standard Error 1.08 |
| ACU-D1 Ointment Vehicle | Change From Baseline in Papules + Pustules Lesions at Weeks 2, 4, 8, and 12 | Week 12 | -12.03 number of lesions | Standard Error 1.62 |
| ACU-D1 Ointment Vehicle | Change From Baseline in Papules + Pustules Lesions at Weeks 2, 4, 8, and 12 | Week 2 | -8.97 number of lesions | Standard Error 1.67 |
| ACU-D1 Ointment Vehicle | Change From Baseline in Papules + Pustules Lesions at Weeks 2, 4, 8, and 12 | Week 8 | -11.65 number of lesions | Standard Error 1.75 |
| ACU-D1 Ointment Vehicle | Change From Baseline in Papules + Pustules Lesions at Weeks 2, 4, 8, and 12 | Week 4 | -9.90 number of lesions | Standard Error 1.57 |
Comparison: Change from baseline at Week 2p-value: 0.33395% CI: [-2.135, 6.139]t-test, 2 sided
Comparison: Change from baseline at Week 4p-value: 0.59195% CI: [-4.882, 2.822]t-test, 2 sided
Comparison: Change from baseline at Week 8p-value: 0.25495% CI: [-1.84, 6.758]t-test, 2 sided
Comparison: Change from baseline at Week 12p-value: 0.35695% CI: [-2.131, 5.779]t-test, 2 sided
Secondary
Change From Baseline in Pustule Lesions at Weeks 2, 4, 8, and 12
Pustule - raised inflammatory lesions, \<0.5 cm in diameter with visible purulent material
Time frame: Baseline; Weeks 2, 4, 8, and 12
Population: MITT population. Number of participants analyzed included participants with available data at specified visits.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| ACU-D1 Ointment | Change From Baseline in Pustule Lesions at Weeks 2, 4, 8, and 12 | Week 2 | -0.4 number of lesions | Standard Error 0.43 |
| ACU-D1 Ointment | Change From Baseline in Pustule Lesions at Weeks 2, 4, 8, and 12 | Week 4 | -1.2 number of lesions | Standard Error 0.2 |
| ACU-D1 Ointment | Change From Baseline in Pustule Lesions at Weeks 2, 4, 8, and 12 | Week 8 | -1.1 number of lesions | Standard Error 0.25 |
| ACU-D1 Ointment | Change From Baseline in Pustule Lesions at Weeks 2, 4, 8, and 12 | Week 12 | -1.0 number of lesions | Standard Error 0.31 |
| ACU-D1 Ointment Vehicle | Change From Baseline in Pustule Lesions at Weeks 2, 4, 8, and 12 | Week 12 | -1.04 number of lesions | Standard Error 0.48 |
| ACU-D1 Ointment Vehicle | Change From Baseline in Pustule Lesions at Weeks 2, 4, 8, and 12 | Week 2 | -0.98 number of lesions | Standard Error 0.62 |
| ACU-D1 Ointment Vehicle | Change From Baseline in Pustule Lesions at Weeks 2, 4, 8, and 12 | Week 8 | -1.29 number of lesions | Standard Error 0.38 |
| ACU-D1 Ointment Vehicle | Change From Baseline in Pustule Lesions at Weeks 2, 4, 8, and 12 | Week 4 | -1.63 number of lesions | Standard Error 0.3 |
Comparison: Change from baseline at Week 2p-value: 0.40795% CI: [-0.894, 2.155]t-test, 2 sided
Comparison: Change from baseline at Week 4p-value: 0.29195% CI: [-0.342, 1.109]t-test, 2 sided
Comparison: Change from baseline at Week 8p-value: 0.73495% CI: [-0.763, 1.073]t-test, 2 sided
Comparison: Change from baseline in pustule lesions at Week 12p-value: 0.95295% CI: [-1.128, 1.197]t-test, 2 sided
Secondary
Number of Participants With Adverse Events
Number of participants reporting any adverse event including local tolerability of signs and symptoms of irritation, clinical laboratory safety tests, and vital signs.
Time frame: Baseline to Week 14
Population: Safety population included all randomized participants who received at least 1 dose of study medication.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ACU-D1 Ointment | Number of Participants With Adverse Events | 11 Participants |
| ACU-D1 Ointment Vehicle | Number of Participants With Adverse Events | 4 Participants |
Secondary
Percentage of Participants Who Were Treatment Responders at Week 12
Treatment responders were defined as participants who have either (1) 2 ordinal or more reductions in the IGA score from baseline or (2) an IGA score of 0 or 1. The IGA score is an ordered categorical value ranging from 0 (clear) to 4 (severe). A lower score indicated improvement in the condition. Score 0 (clear): no papules or pustules, no nodules, none or barely perceptible erythema Score 1 (near clear): very few (≤3) papules and/or pustules, no nodules, very mild erythema Score 2 (mild): few papules and pustules present, no nodules, mild erythema Score 3 (moderate): several papules and pustules are the predominant features, ≤2 nodules may be present, moderate erythema Score 4 (severe): numerous papules and pustules, multiple nodules may be present, severe erythema
Time frame: Baseline, Week 12
Population: MITT population. Number of participants analyzed included participants with available IGA score at Week 12.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ACU-D1 Ointment | Percentage of Participants Who Were Treatment Responders at Week 12 | 19.2 percentage of participants |
| ACU-D1 Ointment Vehicle | Percentage of Participants Who Were Treatment Responders at Week 12 | 18.2 percentage of participants |
p-value: 1Fisher Exact
Secondary
Percent Change From Baseline in Investigator's Global Assessment (IGA) Score at Weeks 2, 4, 8, and 12
The IGA score is an ordered categorical value ranging from 0 (clear) to 4 (severe). A lower score indicated improvement in the condition. Score 0 (clear): no papules or pustules, no nodules, none or barely perceptible erythema Score 1 (near clear): very few (≤3) papules and/or pustules, no nodules, very mild erythema Score 2 (mild): few papules and pustules present, no nodules, mild erythema Score 3 (moderate): several papules and pustules are the predominant features, ≤2 nodules may be present, moderate erythema Score 4 (severe): numerous papules and pustules, multiple nodules may be present, severe erythema
Time frame: Baseline; Weeks 2, 4, 8, and 12
Population: MITT population. Number of participants analyzed included participants with available data at specific timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ACU-D1 Ointment | Percent Change From Baseline in Investigator's Global Assessment (IGA) Score at Weeks 2, 4, 8, and 12 | Week 2 | -23 percent change | Standard Deviation 0.2561 |
| ACU-D1 Ointment | Percent Change From Baseline in Investigator's Global Assessment (IGA) Score at Weeks 2, 4, 8, and 12 | Week 4 | -35 percent change | Standard Deviation 0.2387 |
| ACU-D1 Ointment | Percent Change From Baseline in Investigator's Global Assessment (IGA) Score at Weeks 2, 4, 8, and 12 | Week 8 | -31 percent change | Standard Deviation 0.2538 |
| ACU-D1 Ointment | Percent Change From Baseline in Investigator's Global Assessment (IGA) Score at Weeks 2, 4, 8, and 12 | Week 12 | -31 percent change | Standard Deviation 0.2588 |
| ACU-D1 Ointment Vehicle | Percent Change From Baseline in Investigator's Global Assessment (IGA) Score at Weeks 2, 4, 8, and 12 | Week 12 | -26 percent change | Standard Deviation 0.3583 |
| ACU-D1 Ointment Vehicle | Percent Change From Baseline in Investigator's Global Assessment (IGA) Score at Weeks 2, 4, 8, and 12 | Week 2 | -29 percent change | Standard Deviation 0.1653 |
| ACU-D1 Ointment Vehicle | Percent Change From Baseline in Investigator's Global Assessment (IGA) Score at Weeks 2, 4, 8, and 12 | Week 8 | -29 percent change | Standard Deviation 0.2233 |
| ACU-D1 Ointment Vehicle | Percent Change From Baseline in Investigator's Global Assessment (IGA) Score at Weeks 2, 4, 8, and 12 | Week 4 | -26 percent change | Standard Deviation 0.2771 |
Comparison: Percent change from baseline at Week 2p-value: 0.1099Van Elteren test
Comparison: Percent change from baseline at Week 4p-value: 0.1653Van Elteren test
Comparison: Percent change from baseline at Week 8p-value: 0.8437Van Elteren test
Comparison: Percent change from baseline at Week 12p-value: 0.4644Van Elteren test
Other Pre-specified
Number of Participants With Erythema Score Based on Local Tolerability as Assessed by the Investigator at Day 1 (Post-application) and Weeks 2, 4, 8, and 14
Erythema score was evaluated by the investigator on a 0 to 3 scale with a lower score indicating lesser severity. Score 0 (clear): no erythema present Score 1 (mild): slight erythema Score 2 (moderate): definite erythema Score 3 (severe): marked, fiery erythema
Time frame: Day 1 (Post-application) and Weeks 2, 4, 8, and 14
Population: Safety population. Number of participants analyzed included participants with available data at specified timepoints.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| ACU-D1 Ointment | Number of Participants With Erythema Score Based on Local Tolerability as Assessed by the Investigator at Day 1 (Post-application) and Weeks 2, 4, 8, and 14 | Day 1 (Post-application) | Score 0 (clear) | 1 Participants |
| ACU-D1 Ointment | Number of Participants With Erythema Score Based on Local Tolerability as Assessed by the Investigator at Day 1 (Post-application) and Weeks 2, 4, 8, and 14 | Day 1 (Post-application) | Score 1 (mild) | 9 Participants |
| ACU-D1 Ointment | Number of Participants With Erythema Score Based on Local Tolerability as Assessed by the Investigator at Day 1 (Post-application) and Weeks 2, 4, 8, and 14 | Day 1 (Post-application) | Score 2 (moderate) | 12 Participants |
| ACU-D1 Ointment | Number of Participants With Erythema Score Based on Local Tolerability as Assessed by the Investigator at Day 1 (Post-application) and Weeks 2, 4, 8, and 14 | Day 1 (Post-application) | Score 3 (severe) | 5 Participants |
| ACU-D1 Ointment | Number of Participants With Erythema Score Based on Local Tolerability as Assessed by the Investigator at Day 1 (Post-application) and Weeks 2, 4, 8, and 14 | Week 2 | Score 0 (clear) | 0 Participants |
| ACU-D1 Ointment | Number of Participants With Erythema Score Based on Local Tolerability as Assessed by the Investigator at Day 1 (Post-application) and Weeks 2, 4, 8, and 14 | Week 2 | Score 1 (mild) | 12 Participants |
| ACU-D1 Ointment | Number of Participants With Erythema Score Based on Local Tolerability as Assessed by the Investigator at Day 1 (Post-application) and Weeks 2, 4, 8, and 14 | Week 2 | Score 2 (moderate) | 12 Participants |
| ACU-D1 Ointment | Number of Participants With Erythema Score Based on Local Tolerability as Assessed by the Investigator at Day 1 (Post-application) and Weeks 2, 4, 8, and 14 | Week 2 | Score 3 (severe) | 3 Participants |
| ACU-D1 Ointment | Number of Participants With Erythema Score Based on Local Tolerability as Assessed by the Investigator at Day 1 (Post-application) and Weeks 2, 4, 8, and 14 | Week 4 | Score 0 (clear) | 0 Participants |
| ACU-D1 Ointment | Number of Participants With Erythema Score Based on Local Tolerability as Assessed by the Investigator at Day 1 (Post-application) and Weeks 2, 4, 8, and 14 | Week 4 | Score 1 (mild) | 13 Participants |
| ACU-D1 Ointment | Number of Participants With Erythema Score Based on Local Tolerability as Assessed by the Investigator at Day 1 (Post-application) and Weeks 2, 4, 8, and 14 | Week 4 | Score 2 (moderate) | 12 Participants |
| ACU-D1 Ointment | Number of Participants With Erythema Score Based on Local Tolerability as Assessed by the Investigator at Day 1 (Post-application) and Weeks 2, 4, 8, and 14 | Week 4 | Score 3 (severe) | 2 Participants |
| ACU-D1 Ointment | Number of Participants With Erythema Score Based on Local Tolerability as Assessed by the Investigator at Day 1 (Post-application) and Weeks 2, 4, 8, and 14 | Week 8 | Score 0 (clear) | 1 Participants |
| ACU-D1 Ointment | Number of Participants With Erythema Score Based on Local Tolerability as Assessed by the Investigator at Day 1 (Post-application) and Weeks 2, 4, 8, and 14 | Week 8 | Score 1 (mild) | 11 Participants |
| ACU-D1 Ointment | Number of Participants With Erythema Score Based on Local Tolerability as Assessed by the Investigator at Day 1 (Post-application) and Weeks 2, 4, 8, and 14 | Week 8 | Score 2 (moderate) | 13 Participants |
| ACU-D1 Ointment | Number of Participants With Erythema Score Based on Local Tolerability as Assessed by the Investigator at Day 1 (Post-application) and Weeks 2, 4, 8, and 14 | Week 8 | Score 3 (severe) | 2 Participants |
| ACU-D1 Ointment | Number of Participants With Erythema Score Based on Local Tolerability as Assessed by the Investigator at Day 1 (Post-application) and Weeks 2, 4, 8, and 14 | Week 14 | Score 0 (clear) | 2 Participants |
| ACU-D1 Ointment | Number of Participants With Erythema Score Based on Local Tolerability as Assessed by the Investigator at Day 1 (Post-application) and Weeks 2, 4, 8, and 14 | Week 14 | Score 1 (mild) | 8 Participants |
| ACU-D1 Ointment | Number of Participants With Erythema Score Based on Local Tolerability as Assessed by the Investigator at Day 1 (Post-application) and Weeks 2, 4, 8, and 14 | Week 14 | Score 2 (moderate) | 13 Participants |
| ACU-D1 Ointment | Number of Participants With Erythema Score Based on Local Tolerability as Assessed by the Investigator at Day 1 (Post-application) and Weeks 2, 4, 8, and 14 | Week 14 | Score 3 (severe) | 3 Participants |
| ACU-D1 Ointment Vehicle | Number of Participants With Erythema Score Based on Local Tolerability as Assessed by the Investigator at Day 1 (Post-application) and Weeks 2, 4, 8, and 14 | Week 14 | Score 1 (mild) | 3 Participants |
| ACU-D1 Ointment Vehicle | Number of Participants With Erythema Score Based on Local Tolerability as Assessed by the Investigator at Day 1 (Post-application) and Weeks 2, 4, 8, and 14 | Day 1 (Post-application) | Score 0 (clear) | 1 Participants |
| ACU-D1 Ointment Vehicle | Number of Participants With Erythema Score Based on Local Tolerability as Assessed by the Investigator at Day 1 (Post-application) and Weeks 2, 4, 8, and 14 | Week 4 | Score 2 (moderate) | 7 Participants |
| ACU-D1 Ointment Vehicle | Number of Participants With Erythema Score Based on Local Tolerability as Assessed by the Investigator at Day 1 (Post-application) and Weeks 2, 4, 8, and 14 | Day 1 (Post-application) | Score 1 (mild) | 4 Participants |
| ACU-D1 Ointment Vehicle | Number of Participants With Erythema Score Based on Local Tolerability as Assessed by the Investigator at Day 1 (Post-application) and Weeks 2, 4, 8, and 14 | Week 8 | Score 3 (severe) | 0 Participants |
| ACU-D1 Ointment Vehicle | Number of Participants With Erythema Score Based on Local Tolerability as Assessed by the Investigator at Day 1 (Post-application) and Weeks 2, 4, 8, and 14 | Day 1 (Post-application) | Score 2 (moderate) | 4 Participants |
| ACU-D1 Ointment Vehicle | Number of Participants With Erythema Score Based on Local Tolerability as Assessed by the Investigator at Day 1 (Post-application) and Weeks 2, 4, 8, and 14 | Week 4 | Score 3 (severe) | 1 Participants |
| ACU-D1 Ointment Vehicle | Number of Participants With Erythema Score Based on Local Tolerability as Assessed by the Investigator at Day 1 (Post-application) and Weeks 2, 4, 8, and 14 | Day 1 (Post-application) | Score 3 (severe) | 4 Participants |
| ACU-D1 Ointment Vehicle | Number of Participants With Erythema Score Based on Local Tolerability as Assessed by the Investigator at Day 1 (Post-application) and Weeks 2, 4, 8, and 14 | Week 14 | Score 3 (severe) | 3 Participants |
| ACU-D1 Ointment Vehicle | Number of Participants With Erythema Score Based on Local Tolerability as Assessed by the Investigator at Day 1 (Post-application) and Weeks 2, 4, 8, and 14 | Week 2 | Score 0 (clear) | 0 Participants |
| ACU-D1 Ointment Vehicle | Number of Participants With Erythema Score Based on Local Tolerability as Assessed by the Investigator at Day 1 (Post-application) and Weeks 2, 4, 8, and 14 | Week 8 | Score 0 (clear) | 1 Participants |
| ACU-D1 Ointment Vehicle | Number of Participants With Erythema Score Based on Local Tolerability as Assessed by the Investigator at Day 1 (Post-application) and Weeks 2, 4, 8, and 14 | Week 2 | Score 1 (mild) | 7 Participants |
| ACU-D1 Ointment Vehicle | Number of Participants With Erythema Score Based on Local Tolerability as Assessed by the Investigator at Day 1 (Post-application) and Weeks 2, 4, 8, and 14 | Week 14 | Score 0 (clear) | 1 Participants |
| ACU-D1 Ointment Vehicle | Number of Participants With Erythema Score Based on Local Tolerability as Assessed by the Investigator at Day 1 (Post-application) and Weeks 2, 4, 8, and 14 | Week 2 | Score 2 (moderate) | 4 Participants |
| ACU-D1 Ointment Vehicle | Number of Participants With Erythema Score Based on Local Tolerability as Assessed by the Investigator at Day 1 (Post-application) and Weeks 2, 4, 8, and 14 | Week 8 | Score 1 (mild) | 5 Participants |
| ACU-D1 Ointment Vehicle | Number of Participants With Erythema Score Based on Local Tolerability as Assessed by the Investigator at Day 1 (Post-application) and Weeks 2, 4, 8, and 14 | Week 2 | Score 3 (severe) | 2 Participants |
| ACU-D1 Ointment Vehicle | Number of Participants With Erythema Score Based on Local Tolerability as Assessed by the Investigator at Day 1 (Post-application) and Weeks 2, 4, 8, and 14 | Week 14 | Score 2 (moderate) | 5 Participants |
| ACU-D1 Ointment Vehicle | Number of Participants With Erythema Score Based on Local Tolerability as Assessed by the Investigator at Day 1 (Post-application) and Weeks 2, 4, 8, and 14 | Week 4 | Score 0 (clear) | 0 Participants |
| ACU-D1 Ointment Vehicle | Number of Participants With Erythema Score Based on Local Tolerability as Assessed by the Investigator at Day 1 (Post-application) and Weeks 2, 4, 8, and 14 | Week 8 | Score 2 (moderate) | 6 Participants |
| ACU-D1 Ointment Vehicle | Number of Participants With Erythema Score Based on Local Tolerability as Assessed by the Investigator at Day 1 (Post-application) and Weeks 2, 4, 8, and 14 | Week 4 | Score 1 (mild) | 4 Participants |
Other Pre-specified
Number of Participants With Erythema Score Based on Local Tolerability as Assessed by the Investigator at Week 12
Erythema score was evaluated by the investigator on a 0 to 3 scale with a lower score indicating lesser severity. Score 0 (clear): no erythema present Score 1 (mild): slight erythema Score 2 (moderate): definite erythema Score 3 (severe): marked, fiery erythema
Time frame: Week 12
Population: Safety population included all randomized participants who received at least 1 dose of study medication. Number of participants analyzed included participants with available data at specified timepoints.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ACU-D1 Ointment | Number of Participants With Erythema Score Based on Local Tolerability as Assessed by the Investigator at Week 12 | Score 0 (clear) | 1 Participants |
| ACU-D1 Ointment | Number of Participants With Erythema Score Based on Local Tolerability as Assessed by the Investigator at Week 12 | Score 1 (mild) | 14 Participants |
| ACU-D1 Ointment | Number of Participants With Erythema Score Based on Local Tolerability as Assessed by the Investigator at Week 12 | Score 2 (moderate) | 9 Participants |
| ACU-D1 Ointment | Number of Participants With Erythema Score Based on Local Tolerability as Assessed by the Investigator at Week 12 | Score 3 (severe) | 2 Participants |
| ACU-D1 Ointment Vehicle | Number of Participants With Erythema Score Based on Local Tolerability as Assessed by the Investigator at Week 12 | Score 3 (severe) | 1 Participants |
| ACU-D1 Ointment Vehicle | Number of Participants With Erythema Score Based on Local Tolerability as Assessed by the Investigator at Week 12 | Score 0 (clear) | 1 Participants |
| ACU-D1 Ointment Vehicle | Number of Participants With Erythema Score Based on Local Tolerability as Assessed by the Investigator at Week 12 | Score 2 (moderate) | 6 Participants |
| ACU-D1 Ointment Vehicle | Number of Participants With Erythema Score Based on Local Tolerability as Assessed by the Investigator at Week 12 | Score 1 (mild) | 3 Participants |