Trial Outcomes & Findings for NB-UVB Phototherapy With and Without Topical LCD Treatment: a Bilateral Pilot Study (NCT NCT00708851)

Results Overview

Twelve (12) participants were followed over a 12-week treatment period. Treatment was administered bilaterally as they applied LCD solution to one half of their body while receiving full-body NB-UVB light therapy. The difference in their sPGA, and ESI scores of bilateral target lesions were measured across all visits. PGA scores are calculated using a 6-point scale from 0 (clear) to 5 (very severe). Erythema, induration and scaling scores use a 5-point scale from 0 (none) to 4 (very severe).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

12 participants

Primary outcome timeframe

12 weeks of treatment

Results posted on

2015-04-20

Participant Flow

Participant milestones

Participant milestones
Measure	NB-UVB and NB-UVB+LCD NB-UVB Alone: NB-UVB Light Device (311-315 nm) NB-UVB Phototherapy: 3 light exposures / week NB-UVB+LCD: 2 applications of LCD/day + NB-UVB Light Device (311-315 nm): NB-UVB Phototherapy 3 light exposures / week
Overall Study STARTED	12
Overall Study COMPLETED	12
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

NB-UVB Phototherapy With and Without Topical LCD Treatment: a Bilateral Pilot Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	NB-UVB Alone n=12 Participants One leg receives NB-UVB Alone: NB-UVB Light Device (311-315 nm): NB-UVB Phototherapy: 3 light exposures / week Opposite leg receives: LCD therapy 2 applications/day and NB-UVB Light Device (311-315 nm) NB-UVB Phototherapy 3 light exposures / week
Age, Categorical <=18 years	0 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	11 Participants n=99 Participants
Age, Categorical >=65 years	1 Participants n=99 Participants
Age, Continuous	44.41 years n=99 Participants
Sex: Female, Male Female	5 Participants n=99 Participants
Sex: Female, Male Male	7 Participants n=99 Participants
Region of Enrollment United States	12 participants n=99 Participants

PRIMARY outcome

Timeframe: 12 weeks of treatment

Population: Data were analyzed using an intent-to-treat (ITT) population. All enrolled patients were included in the analysis. Missing scores we filled in by last observation carried forward method. All statistical tests were two-sided and used a level of significance of alpha = 0.05.

Twelve (12) participants were followed over a 12-week treatment period. Treatment was administered bilaterally as they applied LCD solution to one half of their body while receiving full-body NB-UVB light therapy. The difference in their sPGA, and ESI scores of bilateral target lesions were measured across all visits. PGA scores are calculated using a 6-point scale from 0 (clear) to 5 (very severe). Erythema, induration and scaling scores use a 5-point scale from 0 (none) to 4 (very severe).

Outcome measures

Outcome measures
Measure	NB-UVB Alone n=12 Participants NB-UVB Alone NB-UVB Light Device (311-315 nm): NB-UVB Phototherapy: 3 light exposures / week	LCD+NB-UVB n=12 Participants LCD+NB-UVB LCD Solution with NB-UVB Phototherapy: LCD Solution: 2 applications / day NB-UVB Phototherapy: 3 light sessions / week
The Difference in Bilateral Static Physician's Global Assessment (sPGA) Scores, and Erythema, Scaling, and Induration (ESI) Scores of Bilateral Target Lesion Scores Across Visits for Each Condition and Between Conditions. Mean Percent Decrease in Desquamation	65.2 percent improvement from baseline Interval 0.0 to 100.0	82.6 percent improvement from baseline Interval 0.0 to 100.0
The Difference in Bilateral Static Physician's Global Assessment (sPGA) Scores, and Erythema, Scaling, and Induration (ESI) Scores of Bilateral Target Lesion Scores Across Visits for Each Condition and Between Conditions. Percent Change in PGA score from Baseline	77.8 percent improvement from baseline Interval 0.0 to 100.0	85.4 percent improvement from baseline Interval 1.0 to 100.0
The Difference in Bilateral Static Physician's Global Assessment (sPGA) Scores, and Erythema, Scaling, and Induration (ESI) Scores of Bilateral Target Lesion Scores Across Visits for Each Condition and Between Conditions. Mean Percent Change in Erythema	88.5 percent improvement from baseline Interval 0.0 to 100.0	88.9 percent improvement from baseline Interval 0.0 to 100.0
The Difference in Bilateral Static Physician's Global Assessment (sPGA) Scores, and Erythema, Scaling, and Induration (ESI) Scores of Bilateral Target Lesion Scores Across Visits for Each Condition and Between Conditions. Mean Percent Change in Induration	84.2 percent improvement from baseline Interval 0.0 to 100.0	85.7 percent improvement from baseline Interval 0.0 to 100.0

SECONDARY outcome

Timeframe: 12 weeks of treatment

Population: Data were analyzed using an intent-to-treat (ITT) population. All enrolled patients were included in the analysis. Missing scores were filled in by last observation carried forward method. All statistical tests were two-sided and used a level of significance of alpha = 0.05.

Number of subjects who experienced and adverse reaction due to UVB + LCD, versus number of subjects who experienced an adverse reaction due to UVB therapy alone.

Outcome measures

Outcome measures
Measure	NB-UVB Alone n=12 Participants NB-UVB Alone NB-UVB Light Device (311-315 nm): NB-UVB Phototherapy: 3 light exposures / week	LCD+NB-UVB n=12 Participants LCD+NB-UVB LCD Solution with NB-UVB Phototherapy: LCD Solution: 2 applications / day NB-UVB Phototherapy: 3 light sessions / week
The Difference in Number and Severity of Treatment-related Adverse Reactions Between Conditions.	3 participants	3 participants

Adverse Events

NB-UVB Alone

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

LCD+NB-UVB

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	NB-UVB Alone n=12 participants at risk NB-UVB Alone NB-UVB Light Device (311-315 nm): NB-UVB Phototherapy: 3 light exposures / week	LCD+NB-UVB n=12 participants at risk LCD+NB-UVB LCD Solution with NB-UVB Phototherapy: LCD Solution: 2 applications / day NB-UVB Phototherapy: 3 light sessions / week
Skin and subcutaneous tissue disorders Erythema	16.7% 2/12 • Number of events 2 • Adverse events for this study were monitored and documented throughout the entire 12 week study. Adverse events were reported directly by the subject to the principal investigator, who then informed the responsible party: NeoStrata Co., Inc.	16.7% 2/12 • Number of events 2 • Adverse events for this study were monitored and documented throughout the entire 12 week study. Adverse events were reported directly by the subject to the principal investigator, who then informed the responsible party: NeoStrata Co., Inc.

Additional Information

Jerry Bagel, MD

Psoriasis Treatment Center of Central New Jersey

Phone: 609-443-4501

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place