Acne Scars - Mixed Atrophic and HypertrophicNCT04606134

Tripeptide/Hexapeptide Topical and Hybrid Laser Treatment for Acne Scarring

A study testing Hybrid fractional laser, Alastin Regenerating Skin Nectar with TriHex Technology and Cetaphil face cream in people with Acne Scars - Mixed Atrophic and Hypertrophic, run by University of Rochester at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

To evaluate the efficacy of a tripeptide/hexapeptide topical (Alastin Regenerating Skin Nectar with TriHex Technology®) in wound healing and scar reduction following Erbium:YAG hybrid resurfacing laser for acne scarring compared to the standard of post-procedure care consisting of a bland moisturizer. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Acne Scars - Mixed Atrophic and Hypertrophic
What is being tested?: Hybrid fractional laser, Alastin Regenerating Skin Nectar with TriHex Technology and Cetaphil face cream
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 10 participants
Where: 1 siteUnited States
Study dates: 13 Feb 2020to 18 Jun 2021
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

male or females
age 18 and older
with evidence of grade II-III acne scars on the face (mild to moderate) as determined by the Goodman \& Baron qualitative global acne scar grading system

Who cannot join

treatment to face with any energy device within 6 months
tanning within 7 days
dermabrasion or chemical peel within 3 months
current use of systemic retinoids
keloidal scaring in the treatment area
use of systemic steroids within 6 months
use of topical products with retinoid, alpha-hydroxyacid, salicylic acid, vitamin C or E within 14 days

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Rochester Medical Center
Rochester, New York, 14642

Other trials in United States

About this study

Official title: A Single Center, Prospective, Blinded Study to Evaluate the Efficacy and Safety of a Tripeptide/Hexapeptide Topical When Used With Er:YAG Hybrid Laser for the Treatment of Acne Scars

Conditions: Acne Scars - Mixed Atrophic and Hypertrophic
Being tested: Hybrid fractional laser, Alastin Regenerating Skin Nectar with TriHex Technology, Cetaphil face cream
Medical subject headings: Hypertrophy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Hybrid fractional laserDevice
two treatments given one month apart
Alastin Regenerating Skin Nectar with TriHex TechnologyOther
applied twice daily
Cetaphil face creamOther
applied twice daily

Study groups in NCT04606134
Study group	Role	What they receive
Experimental	Experimental	Not described Receives: Device: Hybrid fractional laser; Other: Alastin Regenerating Skin Nectar with TriHex Technology
Control	Placebo comparator	Not described Receives: Device: Hybrid fractional laser; Other: Cetaphil face cream

What is being measured

The primary outcome is the main question the study is designed to answer.

Mean Change From Baseline in Erythema
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.
Measured: baseline to day 34
Mean Change From Baseline in Erythema
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.
Measured: baseline to day 4

Secondary outcomes (2)

Mean Change in Skin Barrier Function
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.
Measured: baseline to day 34
Number of Participants Who Scored Skin Appearance as no Change, Improved or Much Improved Using the Global Aesthetic Improvement Scale
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.
Measured: baseline to day 90

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

13 Feb 202018 Jun 2021

First posted28 Oct 2020
Study start13 Feb 2020
Primary completion18 Jun 2021
Study completion18 Jun 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Acne Scars - Mixed Atrophic and HypertrophicStudies of the same condition, open and under way.
More trials run by University of RochesterThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 10 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04606134
Sponsor's protocol ID: STUDY00003126
Status last verified: Apr 2023
First submitted: 21 Oct 2020
Last updated: 13 Apr 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Efficacy and Tolerability of a Hybrid Fractional Laser for the Treatment of Acne Scars in Patients With Skin of Color
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AVAVA MIRIA General Use
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Comparative Effects Of Trichloroacetic Chemical Peel And Fractional Laser
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Active, not recruiting
AV-23-001 AVAVA MIRIA Pilot Study
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Active, not recruiting
The MIRIA Acne Scar Study
Acne Scars - Mixed Atrophic and Hypertrophic

All Acne Scars - Mixed Atrophic and Hypertrophic trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Single Center, Prospective, Blinded Study to Evaluate the Efficacy and Safety of a Tripeptide/Hexapeptide Topical When Used With Er:YAG Hybrid Laser for the Treatment of Acne Scars
ClinicalTrials.gov ID: NCT04606134
Acronym / sponsor ID: STUDY00003126
Conditions: Acne Scars - Mixed Atrophic and Hypertrophic
Study type: Interventional
Recruitment status: Completed
Enrolment: 10 participants (actual)
Lead sponsor: University of RochesterUniversity, hospital or other
Study start: 13 Feb 2020 (actual)
Primary completion: 18 Jun 2021 (actual)
Study completion: 18 Jun 2021 (actual)
First posted: 28 Oct 2020 (actual)
Results: Posted 13 Apr 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Experimental	Experimental	Device: Hybrid fractional laser, Other: Alastin Regenerating Skin Nectar with TriHex Technology
Control	Placebo comparator	Device: Hybrid fractional laser, Other: Cetaphil face cream

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

male or females
age 18 and older
with evidence of grade II-III acne scars on the face (mild to moderate) as determined by the Goodman \& Baron qualitative global acne scar grading system

Key exclusion criteria (7 listed)

treatment to face with any energy device within 6 months
tanning within 7 days
dermabrasion or chemical peel within 3 months
current use of systemic retinoids
keloidal scaring in the treatment area

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Hybrid fractional lasertwo treatments given one month apart	Device	Control, Experimental
Alastin Regenerating Skin Nectar with TriHex Technologyapplied twice daily	Other	Experimental
Cetaphil face creamapplied twice daily	Other	Control

Primary outcome

Mean Change From Baseline in Erythema
Time frame: baseline to day 34
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.
Mean Change From Baseline in Erythema
Time frame: baseline to day 4
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.

2 secondary outcomes

Mean Change in Skin Barrier Function
Time frame: baseline to day 34
Number of Participants Who Scored Skin Appearance as no Change, Improved or Much Improved Using the Global Aesthetic Improvement Scale
Time frame: baseline to day 90

Results and safety

Results posted to the registry on 13 Apr 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Experimental: Alastin Regenerating Skin Nectar With TriHex Technology	6	6
Control: Cetaphil	4	3

Primary outcome: Mean Change From Baseline in Erythema

Time frame: baseline to day 34. Mean (Standard Error). Unit: units on a scale

Measure	Experimental n = 6	Control n = 3
Value	-1.687 (4.461)	5.730 (4.461)

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

Primary outcome: Mean Change From Baseline in Erythema

Time frame: baseline to day 4. Mean (Standard Error). Unit: units on a scale

Measure	Experimental n = 6	Control n = 4
Value	1.768 (4.218)	5.596 (4.218)

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

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: through study completion, approximately 90 days. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Experimental	0 of 6 (0%)	0 of 6 (0%)	0 of 6
Control	0 of 4 (0%)	1 of 4 (25%)	0 of 4

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Acne Scars - Mixed Atrophic and Hypertrophic

Recruiting
Efficacy and Tolerability of a Hybrid Fractional Laser for the Treatment of Acne Scars in Patients With Skin of Color
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AVAVA MIRIA General Use
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The MIRIA Acne Scar Study
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Apr 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean Change From Baseline in Erythema (time frame: baseline to day 34). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04606134.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2023.