Trial Outcomes & Findings for Tripeptide/Hexapeptide Topical and Hybrid Laser Treatment for Acne Scarring (NCT NCT04606134)

Last Updated: 2023-04-13

Results Overview

A colorimeter will be used to measure the erythema index. The range of the index is 0-99 with 0 indicating better outcome. Erythema will be measured at baseline and at follow-up visits. The mean change from baseline will be averaged to get the overall mean for each arm at each follow up visit.

Recruitment status

COMPLETED

Study phase

Target enrollment

10 participants

Primary outcome timeframe

baseline to day 34

Results posted on

2023-04-13

Participant Flow

Participant milestones

Participant milestones
Measure	Experimental: Alastin Regenerating Skin Nectar With TriHex Technology Hybrid fractional laser: two treatments given one month apart Alastin Regenerating Skin Nectar with TriHex Technology: applied twice daily	Control: Cetaphil Hybrid fractional laser: two treatments given one month apart Cetaphil face cream: applied twice daily
Overall Study STARTED	6	4
Overall Study COMPLETED	6	3
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Experimental: Alastin Regenerating Skin Nectar With TriHex Technology Hybrid fractional laser: two treatments given one month apart Alastin Regenerating Skin Nectar with TriHex Technology: applied twice daily	Control: Cetaphil Hybrid fractional laser: two treatments given one month apart Cetaphil face cream: applied twice daily
Overall Study Adverse Event	0	1

Baseline Characteristics

Tripeptide/Hexapeptide Topical and Hybrid Laser Treatment for Acne Scarring

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Experimental: Alastin Regenerating Skin Nectar With TriHex Technology n=6 Participants Hybrid fractional laser: two treatments given one month apart Alastin Regenerating Skin Nectar with TriHex Technology: applied twice daily	Control: Cetaphil n=4 Participants Hybrid fractional laser: two treatments given one month apart Cetaphil face cream: applied twice daily	Total n=10 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	6 Participants n=5 Participants	4 Participants n=7 Participants	10 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	34.6 years n=5 Participants	31.5 years n=7 Participants	33.4 years n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	1 Participants n=7 Participants	5 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	4 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants
Race/Ethnicity, Customized Asian	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race/Ethnicity, Customized African American	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United States	6 participants n=5 Participants	4 participants n=7 Participants	10 participants n=5 Participants

PRIMARY outcome

Timeframe: baseline to day 34

Population: One participant in the control group, discontinued prior to Day 30.

Outcome measures

Outcome measures
Measure	Experimental n=6 Participants Hybrid fractional laser: two treatments given one month apart Alastin Regenerating Skin Nectar with TriHex Technology: applied twice daily	Control n=3 Participants Hybrid fractional laser: two treatments given one month apart Cetaphil face cream: applied twice daily
Mean Change From Baseline in Erythema	-1.687 units on a scale Standard Error 4.461	5.730 units on a scale Standard Error 4.461

PRIMARY outcome

Timeframe: baseline to day 4

Population: One participant in the control group, discontinued prior to Day 30.

Outcome measures

Outcome measures
Measure	Experimental n=6 Participants Hybrid fractional laser: two treatments given one month apart Alastin Regenerating Skin Nectar with TriHex Technology: applied twice daily	Control n=4 Participants Hybrid fractional laser: two treatments given one month apart Cetaphil face cream: applied twice daily
Mean Change From Baseline in Erythema	1.768 units on a scale Standard Error 4.218	5.596 units on a scale Standard Error 4.218

SECONDARY outcome

Timeframe: baseline to day 34

Population: One participant in the control group discontinued prior to second laser treatment, Day 30.

Barrier function will be measured by transepidermal water loss in grams/m2(hour). The lower the water loss the better the barrier function of the skin. Barrier function will be measured at baseline, days of laser treatment and 4 days after treatment. Laser treatment will occur at baseline and day 30. The mean change from baseline, at each follow-up visit, will be averaged to get the overall mean for each arm.

Outcome measures

Outcome measures
Measure	Experimental n=6 Participants Hybrid fractional laser: two treatments given one month apart Alastin Regenerating Skin Nectar with TriHex Technology: applied twice daily	Control n=4 Participants Hybrid fractional laser: two treatments given one month apart Cetaphil face cream: applied twice daily
Mean Change in Skin Barrier Function Day 4	6.502 g/m^2h Standard Error 6.650	21.59 g/m^2h Standard Error 6.650
Mean Change in Skin Barrier Function Day 34	2.858 g/m^2h Standard Error 7.233	39.07 g/m^2h Standard Error 7.233

SECONDARY outcome

Timeframe: baseline to day 90

Population: One participant in the control discontinued prior to Day 90.

The Global Aesthetic Improvement Scale measures the appearance of the skin as reported by the participant. 1=worse; appearance has worsened compared with the original condition, 2=no change; appearance remains the same as the original condition, 3=improved; better than the initial condition, 4=much improved; marked improvement but not completely optimal, 5=very much improved; excellent or exceptional improvement. The number of participants within each grade will be reported.

Outcome measures

Outcome measures
Measure	Experimental n=6 Participants Hybrid fractional laser: two treatments given one month apart Alastin Regenerating Skin Nectar with TriHex Technology: applied twice daily	Control n=3 Participants Hybrid fractional laser: two treatments given one month apart Cetaphil face cream: applied twice daily
Number of Participants Who Scored Skin Appearance as no Change, Improved or Much Improved Using the Global Aesthetic Improvement Scale Much Improved	0 participants	1 participants
Number of Participants Who Scored Skin Appearance as no Change, Improved or Much Improved Using the Global Aesthetic Improvement Scale Improved	4 participants	1 participants
Number of Participants Who Scored Skin Appearance as no Change, Improved or Much Improved Using the Global Aesthetic Improvement Scale No Change	2 participants	1 participants

Adverse Events

Experimental

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Experimental n=6 participants at risk Hybrid fractional laser: two treatments given one month apart Alastin Regenerating Skin Nectar with TriHex Technology: applied twice daily	Control n=4 participants at risk Hybrid fractional laser: two treatments given one month apart Cetaphil face cream: applied twice daily
Skin and subcutaneous tissue disorders Melasma	0.00% 0/6 • through study completion, approximately 90 days Adverse event collection did not differ from the clinicaltrials.gov definition.	25.0% 1/4 • Number of events 1 • through study completion, approximately 90 days Adverse event collection did not differ from the clinicaltrials.gov definition.

Additional Information

Mara Weinstein MD

University of Rochester Medical Center

Phone: (585) 275-7546

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place