State University of New York - Downstate Medical Center
Who can join
Eligibility, any sex, with Fibrosis or Skin Scarring. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Change in Scar Pliability Between the Treated and Control Incision Sites as Measured by Skin Induration at Three Follow-up Time Points Compared to BaselinePrimary· Baseline assessment was completed on post-operative day 5, before LED-RL or mock phototherapy treatment. Follow-up visits were scheduled on approximately post-operative day 30 (1 month), post-operative 90 (3 months), and post-operative day 180 (6 months).
The SkinFibroMeter, a non-invasive indentation instrument, will be used to evaluate the induration of the skin and subcutaneous tissue (i.e., hardness) of the LED-RL-treated scar versus the untreated scar. Skin induration is measured in Newtons (N).
Baseline
Group
Value
95% CI
LED-RL Phototherapy Group 1
.08
.04 – .14
Mock Irradiation Group 1
.05
.02 – .08
LED-RL Phototherapy Group 2
.09
.03 – .13
Mock Irradiation Group 2
.06
.04 – .08
LED-RL Phototherapy Group 3
.06
.04 – .07
Mock Irradiation Group 3
.07
.02 – .08
1 month
Group
Value
95% CI
LED-RL Phototherapy Group 1
.05
.04 – .08
Mock Irradiation Group 1
.04
.03 – .08
LED-RL Phototherapy Group 2
.06
.04 – .08
Mock Irradiation Group 2
.05
.03 – .12
LED-RL Phototherapy Group 3
.05
.03 – .08
Mock Irradiation Group 3
.04
.02 – .04
3 months
Group
Value
95% CI
LED-RL Phototherapy Group 1
.03
.03 – .06
Mock Irradiation Group 1
.04
.02 – .05
LED-RL Phototherapy Group 2
.04
.03 – .07
Mock Irradiation Group 2
.04
.04 – .07
LED-RL Phototherapy Group 3
.05
.04 – .06
Mock Irradiation Group 3
.06
.04 – .08
6 months
Group
Value
95% CI
LED-RL Phototherapy Group 1
.03
.02 – .03
Mock Irradiation Group 1
.03
.02 – .03
LED-RL Phototherapy Group 2
.02
.02 – .03
Mock Irradiation Group 2
.03
.03 – .03
LED-RL Phototherapy Group 3
.03
.02 – .03
Mock Irradiation Group 3
.02
.02 – .03
Observer Scar Assessment ScaleSecondary· Baseline assessment was completed on post-operative day 5, before LED-RL or mock phototherapy treatment. Follow-up visits were scheduled on approximately post-operative day 30 (1 month), post-operative 90 (3 months), and post-operative day 180 (6 months).
The scale consists of six items rated from 1 to 10, where 1 is "normal skin" and 10 is the "worst imaginable scar". The observer (i.e., investigator) evaluates scar vascularity, pigmentation, thickness, relief, pliability, and surface area. The scores of each of the six items are summed for a total score (range 6 to 60).
Baseline
Group
Value
95% CI
LED-RL Phototherapy Group 1
16.5
14.0 – 20.0
Mock Irradiation Group 1
16.5
15.0 – 21.0
LED-RL Phototherapy Group 2
19.0
16.0 – 21.0
Mock Irradiation Group 2
14.0
13.0 – 17.0
LED-RL Phototherapy Group 3
18.0
16.0 – 19.0
Mock Irradiation Group 3
16.5
15.0 – 20.0
1 month
Group
Value
95% CI
LED-RL Phototherapy Group 1
17.0
15.0 – 18.0
Mock Irradiation Group 1
17.0
14.0 – 19.0
LED-RL Phototherapy Group 2
13.0
11.0 – 16.0
Mock Irradiation Group 2
17.5
11.0 – 19.0
LED-RL Phototherapy Group 3
19.0
17.0 – 21.0
Mock Irradiation Group 3
13.0
12.0 – 15.0
3 months
Group
Value
95% CI
LED-RL Phototherapy Group 1
12.5
11.5 – 17.0
Mock Irradiation Group 1
15.0
14.0 – 16.0
LED-RL Phototherapy Group 2
12.0
11.0 – 18.0
Mock Irradiation Group 2
14.0
9.0 – 18.0
LED-RL Phototherapy Group 3
15.0
12.0 – 19.0
Mock Irradiation Group 3
13.0
12.0 – 14.0
6 months
Group
Value
95% CI
LED-RL Phototherapy Group 1
9.0
8.0 – 18.0
Mock Irradiation Group 1
12.5
11.0 – 14.0
LED-RL Phototherapy Group 2
8.0
8.0 – 20.0
Mock Irradiation Group 2
14.0
12.0 – 16.0
LED-RL Phototherapy Group 3
13.0
10.0 – 15.0
Mock Irradiation Group 3
12.0
8.0 – 19.0
Dermal Collagen ConcentrationSecondary· Baseline assessment was completed on post-operative day 5, before LED-RL or mock phototherapy treatment. Follow-up visits were scheduled on approximately post-operative day 30 (1 month), post-operative 90 (3 months), and post-operative day 180 (6 months).
A non-invasive, handheld diffuse reflectance probe will be used to measure collagen concentration in the dermis at each incision site. The scale ranges from 10 to 99 and the collagen measurement corresponds to the half of the optical scattering coefficient of the dermis.
Baseline
Group
Value
95% CI
LED-RL Phototherapy Group 1
48.7
41.0 – 59.5
Mock Irradiation Group 1
52.0
37.0 – 62.6
LED-RL Phototherapy Group 2
51.0
34.0 – 59.0
Mock Irradiation Group 2
50.5
42.0 – 62.0
LED-RL Phototherapy Group 3
47.7
39.3 – 62.0
Mock Irradiation Group 3
52.5
46.0 – 62.0
1 month
Group
Value
95% CI
LED-RL Phototherapy Group 1
60.3
50.0 – 62.0
Mock Irradiation Group 1
47.0
29.3 – 56.3
LED-RL Phototherapy Group 2
50.7
44.7 – 58.0
Mock Irradiation Group 2
55.2
43.7 – 60.0
LED-RL Phototherapy Group 3
52.7
42.3 – 60.7
Mock Irradiation Group 3
57.0
48.3 – 60.3
3 months
Group
Value
95% CI
LED-RL Phototherapy Group 1
57.5
47.8 – 60.3
Mock Irradiation Group 1
57.4
55.5 – 61.5
LED-RL Phototherapy Group 2
58.3
55.0 – 60.7
Mock Irradiation Group 2
57.3
54.7 – 58.0
LED-RL Phototherapy Group 3
58.7
48.0 – 59.6
Mock Irradiation Group 3
58.7
55.6 – 62.0
6 months
Group
Value
95% CI
LED-RL Phototherapy Group 1
57.0
55.3 – 58.7
Mock Irradiation Group 1
56.5
53.0 – 60.3
LED-RL Phototherapy Group 2
60.0
56.0 – 61.7
Mock Irradiation Group 2
61.0
54.7 – 61.3
LED-RL Phototherapy Group 3
56.7
50.3 – 57.0
Mock Irradiation Group 3
59.3
56.7 – 61.3
Dermal Water ConcentrationSecondary· Baseline assessment was completed on post-operative day 5, before LED-RL or mock phototherapy treatment. Follow-up visits were scheduled on approximately post-operative day 30 (1 month), post-operative 90 (3 months), and post-operative day 180 (6 months).
A non-invasive, handheld diffuse reflectance probe will be used to measure water concentration in the dermis at each incision site. Infrared light is emitted at different wavelengths to retrieve the scattering and the absorption coefficients of the dermis. The more water, the less reflectance. Concentration ranges from 40% to 85%.
Baseline
Group
Value
95% CI
LED-RL Phototherapy Group 1
63.0
60.0 – 64.3
Mock Irradiation Group 1
65.3
62.3 – 66.0
LED-RL Phototherapy Group 2
60.7
58.7 – 62.0
Mock Irradiation Group 2
62.7
60.0 – 66.0
LED-RL Phototherapy Group 3
63.2
62.0 – 67.7
Mock Irradiation Group 3
66.2
63.0 – 68.0
1 month
Group
Value
95% CI
LED-RL Phototherapy Group 1
64.0
62.0 – 65.0
Mock Irradiation Group 1
62.3
61.3 – 63.3
LED-RL Phototherapy Group 2
60.2
58.3 – 61.7
Mock Irradiation Group 2
62.3
58.3 – 63.3
LED-RL Phototherapy Group 3
60.6
58.7 – 62.7
Mock Irradiation Group 3
64.0
60.0 – 65.0
3 months
Group
Value
95% CI
LED-RL Phototherapy Group 1
63.0
59.7 – 67.8
Mock Irradiation Group 1
61.4
59.0 – 67.3
LED-RL Phototherapy Group 2
63.0
59.7 – 66.3
Mock Irradiation Group 2
60.7
59.3 – 62.3
LED-RL Phototherapy Group 3
61.7
60.6 – 63.3
Mock Irradiation Group 3
62.0
57.0 – 67.6
6 months
Group
Value
95% CI
LED-RL Phototherapy Group 1
62.5
59.0 – 64.3
Mock Irradiation Group 1
61.2
59.7 – 64.0
LED-RL Phototherapy Group 2
63.7
62.3 – 68.3
Mock Irradiation Group 2
63.0
62.7 – 64.7
LED-RL Phototherapy Group 3
62.0
61.3 – 62.3
Mock Irradiation Group 3
64.0
61.3 – 64.7
Number of Participants Experiencing Adverse Events in Each Treatment GroupSecondary· From first LED-RL and mock phototherapy treatment session on post-operative day 5 until final follow-up visit on post-operative day 180 (6 month follow-up).
Subjects will be provided with a daily diary to record any adverse events experienced during the three-week intervention period. Treatment sessions will be monitored closely for the occurrence of any safety issues or adverse events, as reported by the subject or observed by the clinical research team. At each follow up visit, patients will be asked about adverse effects.
Group
Value
95% CI
LED-RL Phototherapy Group 1
0
Mock Irradiation Group 1
0
LED-RL Phototherapy Group 2
1
Mock Irradiation Group 2
0
LED-RL Phototherapy Group 3
1
Mock Irradiation Group 3
0
LED-RL Phototherapy Group 1
0
Mock Irradiation Group 1
0
LED-RL Phototherapy Group 2
0
Mock Irradiation Group 2
0
LED-RL Phototherapy Group 3
1
Mock Irradiation Group 3
0
LED-RL Phototherapy Group 1
10
Mock Irradiation Group 1
10
LED-RL Phototherapy Group 2
9
Mock Irradiation Group 2
10
LED-RL Phototherapy Group 3
8
Mock Irradiation Group 3
10
Patient Scar Assessment ScaleSecondary· Baseline assessment was completed on post-operative day 5, before LED-RL or mock phototherapy treatment. Follow-up visits were scheduled on approximately post-operative day 30 (1 month), post-operative 90 (3 months), and post-operative day 180 (6 months).
The scale consists of six items rated from 1 to 10, where 1 is "normal skin" and 10 is the "worst imaginable scar". The patient assesses pain, itching, color, stiffness, thickness, and irregularity. The scores of each of the six items are summed for a total score (range 6 to 60).
Baseline
Group
Value
95% CI
LED-RL Phototherapy Group 1
36.0
27.0 – 42.0
Mock Irradiation Group 1
37.0
24.0 – 41.0
LED-RL Phototherapy Group 2
32.0
23.0 – 34.0
Mock Irradiation Group 2
30.5
27.0 – 32.0
LED-RL Phototherapy Group 3
26.5
21.0 – 33.0
Mock Irradiation Group 3
28.5
24.0 – 48.0
1 month
Group
Value
95% CI
LED-RL Phototherapy Group 1
25.0
21.0 – 34.0
Mock Irradiation Group 1
25.0
19.0 – 34.0
LED-RL Phototherapy Group 2
24.0
19.0 – 29.0
Mock Irradiation Group 2
23.5
18.0 – 30.0
LED-RL Phototherapy Group 3
17.0
13.0 – 37.0
Mock Irradiation Group 3
26.0
13.0 – 37.0
3 months
Group
Value
95% CI
LED-RL Phototherapy Group 1
12.5
12.0 – 18.0
Mock Irradiation Group 1
15.0
12.0 – 25.5
LED-RL Phototherapy Group 2
18.0
17.0 – 26.0
Mock Irradiation Group 2
21.0
18.0 – 26.0
LED-RL Phototherapy Group 3
17.5
14.0 – 32.0
Mock Irradiation Group 3
20.0
12.0 – 26.0
6 months
Group
Value
95% CI
LED-RL Phototherapy Group 1
12.0
7.0 – 17.0
Mock Irradiation Group 1
10.5
10.0 – 12.0
LED-RL Phototherapy Group 2
23.0
12.0 – 28.0
Mock Irradiation Group 2
18.0
16.0 – 24.0
LED-RL Phototherapy Group 3
13.0
10.0 – 25.0
Mock Irradiation Group 3
17.0
11.0 – 26.0
Adverse events — posted to ClinicalTrials.gov
Time frame: LED-RL and mock phototherapy treatment sessions were monitored for the occurrence of safety concerns and AEs, as reported by the patient or observed by the research team. Patients recorded AEs during the three-week LED-RL and mock phototherapy treatment period in a home diary. At each visit, participants were asked about AEs..
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Skin scarring (fibrosis) is a common complication in the wound healing process and remains a therapeutic challenge. Scar formation often occurs following injury to the skin such as surgery, trauma, and burns. The goal of this study is to evaluate the safety and efficacy of visible red light as a modality to reduce skin scarring after mini-facelift surgery. Based on laboratory data, light emitting diode-red light (LED-RL) phototherapy may lessen post-surgical skin fibrosis clinically.
Publications & conference data
4 peer-reviewed publications reference this trial (live from Europe PMC):
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by State University of New York - Downstate Medical Center
Last refreshed: 1 June 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03795116.