Registered outcomes14

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

1 to 14 of 14

List	Outcome	Time frame	Description
Primary	Change From Baseline in Facial Inflammatory Lesion Counts at Week 12	Baseline, Week 12	The number of facial inflammatory lesions (pustules, papules, and nodular lesions) on the forehead, left and right cheeks, nose, and chin were counted. Baseline was defined as the last available measurement taken prior to the first dose of study treatment.
Secondary	Change From Baseline in Facial Inflammatory Lesion Counts at Weeks 2, 4, 8, and 20	Baseline, Weeks 2, 4, 8, and 20	The number of facial inflammatory lesions (pustules, papules, and nodular lesions) on the forehead, left and right cheeks, nose, and chin were counted. Baseline was defined as the last available measurement taken prior to the first dose of study treatment.
Secondary	Percent Change From Baseline in Facial Inflammatory Lesion Counts at Weeks 2, 4, 8, 12, and 20	Baseline, Weeks 2, 4, 8, 12 and 20	The number of facial inflammatory lesions (pustules, papules, and nodular lesions) on the forehead, left and right cheeks, nose, and chin were counted. Baseline was defined as the last available measurement taken prior to the first dose of study treatment.
Secondary	Change From Baseline in Facial Non-inflammatory Lesion Counts at Weeks 2, 4, 8, 12, and 20	Baseline, Weeks 2, 4, 8, 12, and 20	The number of facial non-inflammatory lesions (open and closed comedones) on the forehead, left and right cheeks, and chin was counted. Baseline was defined as the last available measurement taken prior to the first dose of study treatment.
Secondary	Percent Change From Baseline in Facial Non-Inflammatory Lesion Counts at Weeks 2, 4, 8, 12, and 20	Baseline, Weeks 2, 4, 8, 12, and 20	The number of facial non-inflammatory lesions (open and closed comedones) on the forehead, left and right cheeks, and chin was counted. Baseline was defined as the last available measurement taken prior to the first dose of study treatment.
Secondary	Change From Baseline in Total Facial Lesion (Inflammatory and Non-inflammatory Lesions) Counts at Weeks 2, 4, 8, 12, and 20	Baseline, Weeks 2, 4, 8, 12, and 20	The number of facial inflammatory (pustules, papules, and nodular lesions) and non-inflammatory (open and closed comedones) lesions on the forehead, left and right cheeks, nose, and chin were counted. Baseline was defined as the last available measurement taken prior to the first dose of study treatment.
Secondary	Percent Change From Baseline in Total Facial Lesion (Inflammatory and Non-inflammatory Lesions) Counts at Weeks 2, 4, 8, 12, and 20	Baseline, Weeks 2, 4, 8, 12, and 20	The number of facial inflammatory (pustules, papules, and nodular lesions) and non-inflammatory (open and closed comedones) lesions on the forehead, left and right cheeks, nose, and chin were counted. Baseline was defined as the last available measurement taken prior to the first dose of study treatment.
Secondary	Change From Baseline in Facial Investigator's Global Assessment (IGA) at Weeks 2, 4, 8, 12, and 20	Baseline, Weeks 2, 4, 8, 12, and 20	The Facial IGA was a global assessment that was used to assess the current state of acne vulgaris (AV) on the face at each visit. It is a 5-point morphological assessment ranging from 0 (clear) to 4 (severe). Clear (0): clear skin with no inflammatory or non-inflammatory lesions Almost Clear (1): A few scattered comedowns and a few small papules Mild (2): Easily recognizable; less than half the surface is involved. some comedowns and some papules and pustules Moderate (3): More than half of the surface is involved. Many comedowns, papules, and pustules. One nodule may be present Severe (4): Entire surface is involved. Covered with comedowns, numerous papules and pustules. Few nodules may be present. The Facial IGA was an overall global evaluation that was performed at an arm's length distance from the participant and must be performed before the acne lesion count.
Secondary	Percentage of Participants Achieving a Facial IGA of Clear (0) or Almost Clear (1) With at Least a 2-grade Decrease From Baseline at Weeks 2, 4, 8, 12, and 20	Baseline, Weeks 2, 4, 8, 12, and 20	The Facial IGA was a global assessment that was used to assess the current state of AV on the face at each visit. It is a 5-point morphological assessment ranging from 0 (clear) to 4 (severe). Clear (0): clear skin with no inflammatory or non-inflammatory lesions Almost Clear (1): A few scattered comedowns and a few small papules Mild (2): Easily recognizable; less than half the surface is involved. some comedowns and some papules and pustules Moderate (3): More than half of the surface is involved. Many comedowns, papules, and pustules. One nodule may be present Severe (4): Entire surface is involved. Covered with comedowns, numerous papules and pustules. Few nodules may be present. The Facial IGA was an overall global evaluation that was performed at an arm's length distance from the participant and must be performed before the acne lesion count.
Secondary	Percentage of Participants in Each Response Category for the Patient Global Impression of Severity (PGI-S) at Weeks 2, 4, 8, 12, and 20	Baseline, Weeks 2, 4, 8, 12, and 20	PGI- S was a single-item question, which asks the participant to rate the current severity of AV. The response options were: Clear Skin (1) Mild (2) Moderate (3) Severe (4) Higher score indicated more severity.
Secondary	Percentage of Participants in Each Response Category for the Patient Global Impression of Change (PGI-C) at Weeks 2, 4, 8, 12, and 20	Baseline, Weeks 2, 4, 8, 12, and 20	PGI-C was a single-item, self-administered questionnaire, which asked the participant to rate the change in their symptom severity. Scores ranged from 1 (Very much better) to 7 (Very much worse). Very much better (1) Much better (2) A little better (3) No change (4) A little worse (5) Much worse (6) Very much worse (7) Higher score indicated more severity.
Secondary	Change From Baseline in Dermatology Life Quality Index Questionnaire (DLQI) Total Score at Weeks 2, 4, 8, 12, and 20	Baseline, Weeks 2, 4, 8, 12, and 20	DLQI was a simple 10-question validated questionnaire, each question was scored from 0 (not relevant/not at all) to 3 (very much). The DLQI total score ranged from 0 (no effect on participant's life) to 30 (extremely large effect on participant's life). The aim of this participant-reported questionnaire was to measure how much the skin condition had affected the participant's quality of life. The DLQI was administered to participants ≥ 16 years of age. Participants were administered the same questionnaire during the entire study based on their age at Day 1.
Secondary	Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) Total Score at Weeks 2, 4, 8, 12, and 20	Baseline, Weeks 2, 4, 8, 12, and 20	CDLQI was a simple 10-question validated questionnaire, each question was scored from 0 (not relevant/not at all) to 3 (very much). The CDLQI total score ranged from 0 (no effect on participant's life) to 30 (extremely large effect on participant's life). The aim of this participant-reported questionnaire was to measure how much the skin condition had affected the participant's quality of life. The CDLQI was administered to participants \< 16 years of age. Participants were administered the same questionnaire during the entire study based on their age at Day 1.
Secondary	Number of Participants With Treatment Emergent Adverse Events (TEAEs)	First dose of study drug until end of study (up to 20 weeks)	An AE was defined as any untoward medical occurrence in a participant temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study treatment that did not necessarily have a causal relationship with treatment. An AE was considered "serious" if it resulted in death, life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, congenital anomaly/birth defect, other important medical events. TEAE was defined as a new event that occurred during or after first dose of study treatment or any event present at baseline that worsens in either intensity or frequency after first dose of study treatment.

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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