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Trial Outcomes & Findings for Laser Treatment of Moderate to Severe Acne Vulgaris (NCT NCT04466527)

NCT ID: NCT04466527

Last Updated: 2026-06-01

Results Overview

Lesion count is a tally of all different types of blemishes (comedones, papules, pustules, nodules, cysts) on the face. In this study, change in lesion count represents the change in subjects' lesion count post-treatment. A negative change in lesion count indicates that acne improved whereas a positive change in lesion count indicates that acne worsened.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

4 participants

Primary outcome timeframe

3 months

Results posted on

2026-06-01

Participant Flow

Participant milestones

Participant milestones
Measure
Full-face Treatment
3 laser sessions (whole face), up to 22 subjects
Localized Treatment
1 laser session on 1-3 selected lesions, up to 22 subjects
Overall Study
STARTED
4
0
Overall Study
COMPLETED
4
0
Overall Study
NOT COMPLETED
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Full-face Treatment
n=4 Participants
3 laser sessions (whole face), up to 22 subjects
Localized Treatment
1 laser session on 1-3 selected lesions, up to 22 subjects
Total
n=4 Participants
Total of all reporting groups
Age, Categorical
<=18 years
0 Participants
n=4 Participants
—
0 Participants
n=4 Participants
Age, Categorical
Between 18 and 65 years
4 Participants
n=4 Participants
—
4 Participants
n=4 Participants
Age, Categorical
>=65 years
0 Participants
n=4 Participants
—
0 Participants
n=4 Participants
Sex: Female, Male
Female
2 Participants
n=4 Participants
—
2 Participants
n=4 Participants
Sex: Female, Male
Male
2 Participants
n=4 Participants
—
2 Participants
n=4 Participants
Race and Ethnicity Not Collected
—
—
0 Participants
Race and Ethnicity were not collected from any participant.
Physician's Global Assessment Score
4 units on a scale
STANDARD_DEVIATION 0 • n=4 Participants
—
4 units on a scale
STANDARD_DEVIATION 0 • n=4 Participants
Lesion Count
28.25 Lesions
STANDARD_DEVIATION 16.94 • n=4 Participants
—
28.25 Lesions
STANDARD_DEVIATION 16.94 • n=4 Participants

PRIMARY outcome

Timeframe: 3 months

Population: Data is only available for the full-face treatment arm. The localized treatment arm was not enrolled.

Lesion count is a tally of all different types of blemishes (comedones, papules, pustules, nodules, cysts) on the face. In this study, change in lesion count represents the change in subjects' lesion count post-treatment. A negative change in lesion count indicates that acne improved whereas a positive change in lesion count indicates that acne worsened.

Outcome measures

Outcome measures
Measure
Full-Face Treatment
n=4 Participants
3 laser sessions (whole face), up to 22 subjects
Localized Treatment
1 laser session on 1-3 selected lesions, up to 22 subjects
Change in Lesion Count
-16.75 Lesions
Standard Deviation 16.09
—

SECONDARY outcome

Timeframe: 3 months

Population: Data is only available for the full-face treatment arm. The localized treatment arm was not enrolled.

The Physician's Global Assessment (PGA) score is a clinical scale used by dermatologists to rate the overall severity of acne at a given time. The Acne PGA scales range from 0 to 4 (with 0 being least severe and 4 being most severe). In this study, change in PGA score represents the change in subjects' PGA score following treatment. A negative change in PGA score indicates that acne improved whereas a positive change in PGA score indicates that the acne worsened.

Outcome measures

Outcome measures
Measure
Full-Face Treatment
n=4 Participants
3 laser sessions (whole face), up to 22 subjects
Localized Treatment
1 laser session on 1-3 selected lesions, up to 22 subjects
Change in Physician's Global Assessment (PGA) Score
-1.75 score on a scale
Standard Deviation 1.26
—

Adverse Events

Full-face Treatment

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Localized Treatment

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dieter Manstein

Massachusetts General Hospital

Phone: 617-726-4454

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place