Trial Outcomes & Findings for Comparison of 1,550-nm Laser and Fractional Radiofrequency Microneedle for the Treatment of Acne Scars in Ethnic Skin (NCT NCT03380845)

Last Updated: 2019-11-19

Results Overview

Improvement in acne scarring will be measured by two blinded evaluators both by in-person assessments and by photographic review (digital photography will be used under standardized conditions). A quartile grading scale (1 = 1% to 25%, 2 =26% to 50%, 3 =51% to 75%, 4 = \>76% improvement) will be used to measure acne scar improvement. Higher score means better outcome.

Recruitment status

COMPLETED

Study phase

Target enrollment

4 participants

Primary outcome timeframe

three months after last treatment

Results posted on

2019-11-19

Participant Flow

Unit of analysis: side of the face treated

Participant milestones

Participant milestones
Measure	Bilateral Facial Treatment With Fraxel and Fractora Randomized treatment with Fraxel on one side of the face, and Fractora on the opposite side of the face - the study is a randomized, split-face study in subjects seeking facial acne scar correction. Subjects were treated with Fraxel on one side of the face and Fractora on the other side of the face. The side of the face for each device was randomly assigned.
Overall Study STARTED	4 8
Overall Study COMPLETED	4 8
Overall Study NOT COMPLETED	0 0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Comparison of 1,550-nm Laser and Fractional Radiofrequency Microneedle for the Treatment of Acne Scars in Ethnic Skin

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Split Face Study Bilateral Fraxel Restore vs Fractora n=8 side of the face treated Randomized treatment with Fraxel Restore on one side of the face, and Fractora on the opposite side of the face - the study is a randomized,single-center, split-face study in subjects seeking acne scar correction. Subjects were treated with Fraxel on one side of the face and Fractora on the other side of the face. The side of the face for each device was randomly assigned.
Age, Categorical <=18 years	0 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	4 Participants n=99 Participants
Age, Categorical >=65 years	0 Participants n=99 Participants
Age, Continuous	30 years n=99 Participants
Sex: Female, Male Female	3 Participants n=99 Participants
Sex: Female, Male Male	1 Participants n=99 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=99 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	4 Participants n=99 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants
Region of Enrollment United States	4 participants n=99 Participants
Fitzpatrick Skin Type (FST) Classification FST III	3 Participants n=99 Participants
Fitzpatrick Skin Type (FST) Classification FST VI	1 Participants n=99 Participants

PRIMARY outcome

Timeframe: three months after last treatment

Population: There were 4 participants enrolled and treated, the participants received bilateral facial treatments with Fraxel on one side of the face, and Fractora on the other side of the face

Outcome measures

Outcome measures
Measure	Fraxel Restore on One Side of the Face n=4 side of face treated Fraxel Restore on one side of the face for acne scar correction	Fractora on Other Side of the Face n=4 side of face treated Fractora on other side of the face for acne scar correction
Improvement in Acne Scarring - From Baseline to Three Months After Last Treatment	2 score on a scale Interval 1.0 to 3.0	2 score on a scale Interval 1.0 to 3.0

SECONDARY outcome

Timeframe: treatment visit 1, treatment visit 2, treatment visit 3, three months after last treatment

Population: There were 4 participants enrolled and treated, the participants received bilateral facial treatments with Fraxel on one side of the face, and Fractora on the other side of the face

measure side effects by patient reported adverse events and blinded physician assessment of adverse effects. Parameters, include erythema, edema, blistering, crusting, scarring, hypopigmentation, and hyperpigmentation, will be graded on a 4-point scale (0 = absent, 1= mild, 2 = moderate, and 3 = severe). Higher score means worse outcome.

Outcome measures

Outcome measures
Measure	Fraxel Restore on One Side of the Face n=4 side of face treated Fraxel Restore on one side of the face for acne scar correction	Fractora on Other Side of the Face n=4 side of face treated Fractora on other side of the face for acne scar correction
Comparing Side Effects of the Different Lasers	0 score on a scale Interval 0.0 to 0.0	0 score on a scale Interval 0.0 to 0.0

SECONDARY outcome

Timeframe: treatment visit 1, treatment visit 2, treatment visit 3

Population: There were 4 participants enrolled and treated, the participants received bilateral facial treatments with Fraxel on one side of the face, and Fractora on the other side of the face

Patients will also be evaluated the intensity of pain using a visual analogue scale (0 = absence of pain, 10 = most-severe pain). Higher score means worse outcome

Outcome measures

Outcome measures
Measure	Fraxel Restore on One Side of the Face n=4 side of face treated Fraxel Restore on one side of the face for acne scar correction	Fractora on Other Side of the Face n=4 side of face treated Fractora on other side of the face for acne scar correction
Comparing Intensity of Pain With the Different Lasers	3 score on a scale Interval 2.0 to 5.0	7 score on a scale Interval 6.0 to 8.0

Adverse Events

Fraxel Restore on One Side of the Face

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Fractora on Other Side of the Face

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

Dr. Sandeep Saluja

MGH

Phone: 6466621084

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place