N/A N=16 Supportive Care

Low Level Laser Therapy for Radiation Induced Dermatitis in H & N Squamous Cell Carcinoma

Radiation Dermatitis

Bottom Line

View on ClinicalTrials.gov: NCT02384434 ↗

Enrolled (actual)

Serious AEs

56.3%

Results posted

Jun 2025

Primary outcome: Primary: Grade 3 or Higher Adverse Events — 9 Participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: THOR Laser System for Low Level Laser Therapy (LLLT) (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Heath Skinner
Primary completion: Oct 2020

Outcome Measures

Outcome	Result	p-value
PRIMARY Grade 3 or Higher Adverse Events	9	—
SECONDARY University of Washington Quality of Life Questionnaire (UW-QOL)	35.4; 21; 11.6; 16.7; 25.6; 17.6	—
SECONDARY University of Washington Quality of Life Questionnaire (UW-QOL)	35.4; 21; 11.6; 16.7; 25.6; 17.6	—
SECONDARY University of Washington Quality of Life Questionnaire (UW-QOL)	35.4; 21; 11.6; 16.7; 25.6; 17.6	—
SECONDARY University of Washington Quality of Life Questionnaire (UW-QOL)	35.4; 21; 11.6; 16.7; 25.6; 17.6	—
SECONDARY University of Washington Quality of Life Questionnaire (UW-QOL)	35.4; 21; 11.6; 16.7; 25.6; 17.6	—
SECONDARY University of Washington Quality of Life Questionnaire (UW-QOL)	35.4; 21; 11.6; 16.7; 25.6; 17.6	—
SECONDARY University of Washington Quality of Life Questionnaire (UW-QOL)	35.4; 21; 11.6; 16.7; 25.6; 17.6	—
SECONDARY Brief Pain Inventory (BPI)	2.2; 2; 1.8; 2.4; 1.2; 1.7	—
SECONDARY Brief Pain Inventory (BPI)	2.2; 2; 1.8; 2.4; 1.2; 1.7	—
SECONDARY Brief Pain Inventory (BPI)	2.2; 2; 1.8; 2.4; 1.2; 1.7	—
SECONDARY Brief Pain Inventory (BPI)	2.2; 2; 1.8; 2.4; 1.2; 1.7	—
SECONDARY Brief Pain Inventory (BPI)	2.2; 2; 1.8; 2.4; 1.2; 1.7	—
SECONDARY Brief Pain Inventory (BPI)	2.2; 2; 1.8; 2.4; 1.2; 1.7	—
SECONDARY Brief Pain Inventory (BPI)	2.2; 2; 1.8; 2.4; 1.2; 1.7	—
SECONDARY Dermatology Life Quality Index (DLQI)	3.8; 4; 4; 4.3; 3.5; 4	—
SECONDARY Dermatology Life Quality Index (DLQI)	3.8; 4; 4; 4.3; 3.5; 4	—
SECONDARY Dermatology Life Quality Index (DLQI)	3.8; 4; 4; 4.3; 3.5; 4	—
SECONDARY Dermatology Life Quality Index (DLQI)	3.8; 4; 4; 4.3; 3.5; 4	—
SECONDARY Dermatology Life Quality Index (DLQI)	3.8; 4; 4; 4.3; 3.5; 4	—
SECONDARY Dermatology Life Quality Index (DLQI)	3.8; 4; 4; 4.3; 3.5; 4	—
SECONDARY Dermatology Life Quality Index (DLQI)	3.8; 4; 4; 4.3; 3.5; 4	—

Summary

This study will assess the efficacy of LLLT to mitigate and ameliorate the acneiform-rash, radiation dermatitis, and pain, while assessing its impact on patient reported quality of life.

Eligibility Criteria

Inclusion Criteria

Male or female patients ≥ 18 years of age
Karnofsky performance status > 70
Histologic proof of squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx
No prior radiotherapy to the head and neck region.
No previous systemic chemotherapy or targeted therapy
Must be aware of the neoplastic nature of his/her disease and willingly provide written, informed consent after being informed of the procedure to be followed, the nature of the therapy, alternatives, potential benefits, side-effects, risks and discomforts.
Patients using standard therapies for cetuximab-induced acne-form rash will be included.

Exclusion Criteria

Evidence of distant metastasis on upright chest x-ray (CXR), computed tomography (CT) or other staging studies
Any co-morbidity or condition of sufficient severity to limit full compliance with the protocol per assessment by the investigator
Concurrent serious infection
Continued use of Niacin

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02384434). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.