Trial Outcomes & Findings for Clinical and Histological Evaluation of the Picosure 755nm Laser With Cap Array for Facial Rejuvenation (NCT NCT02107157)

Last Updated: 2021-01-20

Results Overview

Physicians will examine the subjects' facial scarring using the Physician Global Scarring Grading (PGSG) scale. This scale counts and types scars by tallying up of the number and severity of the scars according to an organized grading system, where 0 is the lowest point value and represents no scarring. The theoretical highest score possible is an 84. The change in the score from the baseline to the follow up was collected. A negative change indicates a decrease in points (which indicates improvement).

Recruitment status

COMPLETED

Study phase

Target enrollment

27 participants

Primary outcome timeframe

Baseline and 3 months post last treatment

Results posted on

2021-01-20

Participant Flow

Participant milestones

Participant milestones
Measure	755nm Alexandrite Laser With Cap Array- Acne 755nm Laser with Cap Array Treatment of acne in the facial region.	755nm Alexandrite Laser With Cap Array- Photodamage 755nm Laser with Cap Array Treatment of photodamage in the facial region.	755nm Alexandrite Laser With Cap Array- Biopsy 755nm Laser with Cap Array Biopsy samples were taken of subjects.
Overall Study STARTED	11	12	4
Overall Study COMPLETED	6	11	4
Overall Study NOT COMPLETED	5	1	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

One subject in the acne group withdrew from the study before the first treatment occurred and baseline information was collected. The withdrawal was due to scheduling conflicts.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	755nm Alexandrite Laser With Cap Array- Acne n=10 Participants 755nm Laser with Cap Array	755nm Alexandrite Laser With Cap Array- Photodamage n=12 Participants 755nm Laser with Cap Array	755nm Laser With Cap Array- Biopsy n=4 Participants 755nm Laser with Cap Array	Total n=26 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=10 Participants • One subject in the acne group withdrew from the study before the first treatment occurred and baseline information was collected. The withdrawal was due to scheduling conflicts.	0 Participants n=12 Participants • One subject in the acne group withdrew from the study before the first treatment occurred and baseline information was collected. The withdrawal was due to scheduling conflicts.	0 Participants n=4 Participants • One subject in the acne group withdrew from the study before the first treatment occurred and baseline information was collected. The withdrawal was due to scheduling conflicts.	0 Participants n=26 Participants • One subject in the acne group withdrew from the study before the first treatment occurred and baseline information was collected. The withdrawal was due to scheduling conflicts.
Age, Categorical Between 18 and 65 years	10 Participants n=10 Participants • One subject in the acne group withdrew from the study before the first treatment occurred and baseline information was collected. The withdrawal was due to scheduling conflicts.	12 Participants n=12 Participants • One subject in the acne group withdrew from the study before the first treatment occurred and baseline information was collected. The withdrawal was due to scheduling conflicts.	3 Participants n=4 Participants • One subject in the acne group withdrew from the study before the first treatment occurred and baseline information was collected. The withdrawal was due to scheduling conflicts.	25 Participants n=26 Participants • One subject in the acne group withdrew from the study before the first treatment occurred and baseline information was collected. The withdrawal was due to scheduling conflicts.
Age, Categorical >=65 years	0 Participants n=10 Participants • One subject in the acne group withdrew from the study before the first treatment occurred and baseline information was collected. The withdrawal was due to scheduling conflicts.	0 Participants n=12 Participants • One subject in the acne group withdrew from the study before the first treatment occurred and baseline information was collected. The withdrawal was due to scheduling conflicts.	1 Participants n=4 Participants • One subject in the acne group withdrew from the study before the first treatment occurred and baseline information was collected. The withdrawal was due to scheduling conflicts.	1 Participants n=26 Participants • One subject in the acne group withdrew from the study before the first treatment occurred and baseline information was collected. The withdrawal was due to scheduling conflicts.
Sex: Female, Male Female	10 Participants n=10 Participants • One subject in the acne group withdrew from the study before the first treatment occurred and baseline information was collected. The withdrawal was due to scheduling conflicts.	12 Participants n=12 Participants • One subject in the acne group withdrew from the study before the first treatment occurred and baseline information was collected. The withdrawal was due to scheduling conflicts.	1 Participants n=4 Participants • One subject in the acne group withdrew from the study before the first treatment occurred and baseline information was collected. The withdrawal was due to scheduling conflicts.	23 Participants n=26 Participants • One subject in the acne group withdrew from the study before the first treatment occurred and baseline information was collected. The withdrawal was due to scheduling conflicts.
Sex: Female, Male Male	0 Participants n=10 Participants • One subject in the acne group withdrew from the study before the first treatment occurred and baseline information was collected. The withdrawal was due to scheduling conflicts.	0 Participants n=12 Participants • One subject in the acne group withdrew from the study before the first treatment occurred and baseline information was collected. The withdrawal was due to scheduling conflicts.	3 Participants n=4 Participants • One subject in the acne group withdrew from the study before the first treatment occurred and baseline information was collected. The withdrawal was due to scheduling conflicts.	3 Participants n=26 Participants • One subject in the acne group withdrew from the study before the first treatment occurred and baseline information was collected. The withdrawal was due to scheduling conflicts.
Race/Ethnicity, Customized Race/Ethnicity · Caucasian	4 Participants n=10 Participants • One subject in the acne group withdrew from the study before the first treatment occurred and baseline information was collected. The withdrawal was due to scheduling conflicts.	9 Participants n=12 Participants • One subject in the acne group withdrew from the study before the first treatment occurred and baseline information was collected. The withdrawal was due to scheduling conflicts.	3 Participants n=4 Participants • One subject in the acne group withdrew from the study before the first treatment occurred and baseline information was collected. The withdrawal was due to scheduling conflicts.	16 Participants n=26 Participants • One subject in the acne group withdrew from the study before the first treatment occurred and baseline information was collected. The withdrawal was due to scheduling conflicts.
Race/Ethnicity, Customized Race/Ethnicity · Hispanic	4 Participants n=10 Participants • One subject in the acne group withdrew from the study before the first treatment occurred and baseline information was collected. The withdrawal was due to scheduling conflicts.	1 Participants n=12 Participants • One subject in the acne group withdrew from the study before the first treatment occurred and baseline information was collected. The withdrawal was due to scheduling conflicts.	0 Participants n=4 Participants • One subject in the acne group withdrew from the study before the first treatment occurred and baseline information was collected. The withdrawal was due to scheduling conflicts.	5 Participants n=26 Participants • One subject in the acne group withdrew from the study before the first treatment occurred and baseline information was collected. The withdrawal was due to scheduling conflicts.
Race/Ethnicity, Customized Race/Ethnicity · Asian	2 Participants n=10 Participants • One subject in the acne group withdrew from the study before the first treatment occurred and baseline information was collected. The withdrawal was due to scheduling conflicts.	2 Participants n=12 Participants • One subject in the acne group withdrew from the study before the first treatment occurred and baseline information was collected. The withdrawal was due to scheduling conflicts.	1 Participants n=4 Participants • One subject in the acne group withdrew from the study before the first treatment occurred and baseline information was collected. The withdrawal was due to scheduling conflicts.	5 Participants n=26 Participants • One subject in the acne group withdrew from the study before the first treatment occurred and baseline information was collected. The withdrawal was due to scheduling conflicts.
Fitzpatrick Skin Type Fitzpatrick Skin Type I	0 Participants n=9 Participants • One subject in the acne group withdrew from the study before the first treatment occurred and baseline information was collected. The withdrawal was due to scheduling conflicts. Additionally, one subject in the acne group did not fill out Fitzpatrick Skin Type. The subject missing this baseline information withdrew from the study before the first treatment occurred due to scheduling conflicts.	0 Participants n=12 Participants • One subject in the acne group withdrew from the study before the first treatment occurred and baseline information was collected. The withdrawal was due to scheduling conflicts. Additionally, one subject in the acne group did not fill out Fitzpatrick Skin Type. The subject missing this baseline information withdrew from the study before the first treatment occurred due to scheduling conflicts.	0 Participants n=4 Participants • One subject in the acne group withdrew from the study before the first treatment occurred and baseline information was collected. The withdrawal was due to scheduling conflicts. Additionally, one subject in the acne group did not fill out Fitzpatrick Skin Type. The subject missing this baseline information withdrew from the study before the first treatment occurred due to scheduling conflicts.	0 Participants n=25 Participants • One subject in the acne group withdrew from the study before the first treatment occurred and baseline information was collected. The withdrawal was due to scheduling conflicts. Additionally, one subject in the acne group did not fill out Fitzpatrick Skin Type. The subject missing this baseline information withdrew from the study before the first treatment occurred due to scheduling conflicts.
Fitzpatrick Skin Type Fitzpatrick Skin Type II	2 Participants n=9 Participants • One subject in the acne group withdrew from the study before the first treatment occurred and baseline information was collected. The withdrawal was due to scheduling conflicts. Additionally, one subject in the acne group did not fill out Fitzpatrick Skin Type. The subject missing this baseline information withdrew from the study before the first treatment occurred due to scheduling conflicts.	0 Participants n=12 Participants • One subject in the acne group withdrew from the study before the first treatment occurred and baseline information was collected. The withdrawal was due to scheduling conflicts. Additionally, one subject in the acne group did not fill out Fitzpatrick Skin Type. The subject missing this baseline information withdrew from the study before the first treatment occurred due to scheduling conflicts.	2 Participants n=4 Participants • One subject in the acne group withdrew from the study before the first treatment occurred and baseline information was collected. The withdrawal was due to scheduling conflicts. Additionally, one subject in the acne group did not fill out Fitzpatrick Skin Type. The subject missing this baseline information withdrew from the study before the first treatment occurred due to scheduling conflicts.	4 Participants n=25 Participants • One subject in the acne group withdrew from the study before the first treatment occurred and baseline information was collected. The withdrawal was due to scheduling conflicts. Additionally, one subject in the acne group did not fill out Fitzpatrick Skin Type. The subject missing this baseline information withdrew from the study before the first treatment occurred due to scheduling conflicts.
Fitzpatrick Skin Type Fitzpatrick Skin Type III	4 Participants n=9 Participants • One subject in the acne group withdrew from the study before the first treatment occurred and baseline information was collected. The withdrawal was due to scheduling conflicts. Additionally, one subject in the acne group did not fill out Fitzpatrick Skin Type. The subject missing this baseline information withdrew from the study before the first treatment occurred due to scheduling conflicts.	8 Participants n=12 Participants • One subject in the acne group withdrew from the study before the first treatment occurred and baseline information was collected. The withdrawal was due to scheduling conflicts. Additionally, one subject in the acne group did not fill out Fitzpatrick Skin Type. The subject missing this baseline information withdrew from the study before the first treatment occurred due to scheduling conflicts.	1 Participants n=4 Participants • One subject in the acne group withdrew from the study before the first treatment occurred and baseline information was collected. The withdrawal was due to scheduling conflicts. Additionally, one subject in the acne group did not fill out Fitzpatrick Skin Type. The subject missing this baseline information withdrew from the study before the first treatment occurred due to scheduling conflicts.	13 Participants n=25 Participants • One subject in the acne group withdrew from the study before the first treatment occurred and baseline information was collected. The withdrawal was due to scheduling conflicts. Additionally, one subject in the acne group did not fill out Fitzpatrick Skin Type. The subject missing this baseline information withdrew from the study before the first treatment occurred due to scheduling conflicts.
Fitzpatrick Skin Type Fitzpatrick Skin Type IV	3 Participants n=9 Participants • One subject in the acne group withdrew from the study before the first treatment occurred and baseline information was collected. The withdrawal was due to scheduling conflicts. Additionally, one subject in the acne group did not fill out Fitzpatrick Skin Type. The subject missing this baseline information withdrew from the study before the first treatment occurred due to scheduling conflicts.	4 Participants n=12 Participants • One subject in the acne group withdrew from the study before the first treatment occurred and baseline information was collected. The withdrawal was due to scheduling conflicts. Additionally, one subject in the acne group did not fill out Fitzpatrick Skin Type. The subject missing this baseline information withdrew from the study before the first treatment occurred due to scheduling conflicts.	1 Participants n=4 Participants • One subject in the acne group withdrew from the study before the first treatment occurred and baseline information was collected. The withdrawal was due to scheduling conflicts. Additionally, one subject in the acne group did not fill out Fitzpatrick Skin Type. The subject missing this baseline information withdrew from the study before the first treatment occurred due to scheduling conflicts.	8 Participants n=25 Participants • One subject in the acne group withdrew from the study before the first treatment occurred and baseline information was collected. The withdrawal was due to scheduling conflicts. Additionally, one subject in the acne group did not fill out Fitzpatrick Skin Type. The subject missing this baseline information withdrew from the study before the first treatment occurred due to scheduling conflicts.
Fitzpatrick Skin Type Fitzpatrick Skin Type V	0 Participants n=9 Participants • One subject in the acne group withdrew from the study before the first treatment occurred and baseline information was collected. The withdrawal was due to scheduling conflicts. Additionally, one subject in the acne group did not fill out Fitzpatrick Skin Type. The subject missing this baseline information withdrew from the study before the first treatment occurred due to scheduling conflicts.	0 Participants n=12 Participants • One subject in the acne group withdrew from the study before the first treatment occurred and baseline information was collected. The withdrawal was due to scheduling conflicts. Additionally, one subject in the acne group did not fill out Fitzpatrick Skin Type. The subject missing this baseline information withdrew from the study before the first treatment occurred due to scheduling conflicts.	0 Participants n=4 Participants • One subject in the acne group withdrew from the study before the first treatment occurred and baseline information was collected. The withdrawal was due to scheduling conflicts. Additionally, one subject in the acne group did not fill out Fitzpatrick Skin Type. The subject missing this baseline information withdrew from the study before the first treatment occurred due to scheduling conflicts.	0 Participants n=25 Participants • One subject in the acne group withdrew from the study before the first treatment occurred and baseline information was collected. The withdrawal was due to scheduling conflicts. Additionally, one subject in the acne group did not fill out Fitzpatrick Skin Type. The subject missing this baseline information withdrew from the study before the first treatment occurred due to scheduling conflicts.
Fitzpatrick Skin Type Fitzpatrick Skin Type VI	0 Participants n=9 Participants • One subject in the acne group withdrew from the study before the first treatment occurred and baseline information was collected. The withdrawal was due to scheduling conflicts. Additionally, one subject in the acne group did not fill out Fitzpatrick Skin Type. The subject missing this baseline information withdrew from the study before the first treatment occurred due to scheduling conflicts.	0 Participants n=12 Participants • One subject in the acne group withdrew from the study before the first treatment occurred and baseline information was collected. The withdrawal was due to scheduling conflicts. Additionally, one subject in the acne group did not fill out Fitzpatrick Skin Type. The subject missing this baseline information withdrew from the study before the first treatment occurred due to scheduling conflicts.	0 Participants n=4 Participants • One subject in the acne group withdrew from the study before the first treatment occurred and baseline information was collected. The withdrawal was due to scheduling conflicts. Additionally, one subject in the acne group did not fill out Fitzpatrick Skin Type. The subject missing this baseline information withdrew from the study before the first treatment occurred due to scheduling conflicts.	0 Participants n=25 Participants • One subject in the acne group withdrew from the study before the first treatment occurred and baseline information was collected. The withdrawal was due to scheduling conflicts. Additionally, one subject in the acne group did not fill out Fitzpatrick Skin Type. The subject missing this baseline information withdrew from the study before the first treatment occurred due to scheduling conflicts.

PRIMARY outcome

Timeframe: Baseline and 3 months post last treatment

Population: 4 subjects withdrew due to scheduling conflicts, and 1 moved out of state. 1 subject had completed the photoaging scoring sheet instead of the acne scarring scoring sheet for their followup, so their scores are not reported. 1 subject is missing data, so their score cannot be used.

Outcome measures

Outcome measures
Measure	755nm Alexandrite Laser With Cap Array- Acne n=4 Participants 755nm Laser with Cap Array Treatment of acne in the facial region.
Changes in Facial Scarring Score	-.50 score on a scale Standard Deviation 1

PRIMARY outcome

Timeframe: Baseline and 3 months post last treatment

Population: 1 subject withdrew from the study due to scheduling conflicts.

The photodamage is assessed by examining fine wrinkles, mottled hyperpigmentation, and overall integrated assessment of photodamage. These 3 categories are broken down into their own scales of 0 to 4 based on severity. 0 indicates none, 1 indicates minimal, 2 indicates mild, 3 indicates moderate, and 4 indicates severe. The total points from all 3 categories added up will range from 0 to 12, where 12 is the most photodamage possible. A decrease in score indicates less photodamage.

Outcome measures

Outcome measures
Measure	755nm Alexandrite Laser With Cap Array- Acne n=11 Participants 755nm Laser with Cap Array Treatment of acne in the facial region.
Photodamage Score Change	-.363 score on a scale Standard Deviation 1.20

PRIMARY outcome

Timeframe: 3 months post last treatment

Population: 2 other patients had biopsies performed on them, but did not come in for a biopsy follow up.

Subjects will have one 3mm punch biopsy obtained pretreatment from an inconspicuous area and subsequent biopsies at one or any of the following visits after treatment. Pathologies will be provided by pathologists who are able to determine any developments of dermal mucus, dermal elastic fibers, or changes in collagen III. An increase in any of these categories corresponds with skin rejuvenation.

Outcome measures

Outcome measures
Measure	755nm Alexandrite Laser With Cap Array- Acne n=2 Participants 755nm Laser with Cap Array Treatment of acne in the facial region.
Number of Participants With Signs of New Collagen Generations dermal mucus increased	2 Participants
Number of Participants With Signs of New Collagen Generations dermal elastic fibers increased	2 Participants
Number of Participants With Signs of New Collagen Generations collagen III increased	2 Participants

Adverse Events

755nm Alexandrite Laser With Cap Array- Acne

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

755nm Alexandrite Laser With Cap Array- Photodamage

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

755nm Alexandrite Laser With Cap Array- Biopsy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	755nm Alexandrite Laser With Cap Array- Acne n=11 participants at risk 755nm Laser with Cap Array	755nm Alexandrite Laser With Cap Array- Photodamage n=12 participants at risk 755nm Laser with Cap Array	755nm Alexandrite Laser With Cap Array- Biopsy n=4 participants at risk 755nm Laser with Cap Array
Skin and subcutaneous tissue disorders redness	72.7% 8/11 • Adverse Events occurring will be captured and followed for study duration, approximately 13 months.	100.0% 12/12 • Adverse Events occurring will be captured and followed for study duration, approximately 13 months.	0.00% 0/4 • Adverse Events occurring will be captured and followed for study duration, approximately 13 months.
Skin and subcutaneous tissue disorders edema	72.7% 8/11 • Adverse Events occurring will be captured and followed for study duration, approximately 13 months.	100.0% 12/12 • Adverse Events occurring will be captured and followed for study duration, approximately 13 months.	0.00% 0/4 • Adverse Events occurring will be captured and followed for study duration, approximately 13 months.
Skin and subcutaneous tissue disorders Pinpoint Bleeding	9.1% 1/11 • Adverse Events occurring will be captured and followed for study duration, approximately 13 months.	0.00% 0/12 • Adverse Events occurring will be captured and followed for study duration, approximately 13 months.	0.00% 0/4 • Adverse Events occurring will be captured and followed for study duration, approximately 13 months.
Skin and subcutaneous tissue disorders Swelling	9.1% 1/11 • Adverse Events occurring will be captured and followed for study duration, approximately 13 months.	0.00% 0/12 • Adverse Events occurring will be captured and followed for study duration, approximately 13 months.	0.00% 0/4 • Adverse Events occurring will be captured and followed for study duration, approximately 13 months.
Skin and subcutaneous tissue disorders Acne breakout	9.1% 1/11 • Adverse Events occurring will be captured and followed for study duration, approximately 13 months.	0.00% 0/12 • Adverse Events occurring will be captured and followed for study duration, approximately 13 months.	0.00% 0/4 • Adverse Events occurring will be captured and followed for study duration, approximately 13 months.

Additional Information

Jamie Trimper

Cynosure

Phone: 800-886-2966

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The PI cannot disclose confidential or proprietary information until after it becomes generally known or available to the public.
Publication restrictions are in place

Restriction type: OTHER