Trial Outcomes & Findings for Safety and Tolerability of Oxymetazoline and Energy-Based Therapy in Participants With Rosacea (NCT NCT03380390)

Last Updated: 2019-09-04

Results Overview

An AE is defined as any untoward medical occurrence in a clinical study participant administered a medicinal product that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not it is related to the medicinal (investigational) product. An SAE is any untoward medical occurrence or effect that, at any dose: Results in death, Is life-threatening, Requires or prolongs inpatient hospitalization, Results in persistent or significant disability/incapacity or Results in a congenital anomaly/birth defect.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

46 participants

Primary outcome timeframe

Baseline (Day 1) to Day 56

Results posted on

2019-09-04

Participant Flow

Participant milestones

Participant milestones
Measure	Oxymetazoline + Energy-Based Therapy Participants will receive energy-based therapy (Potassium Titanyl Phosphate \[KTP\], Pulsed Dye Laser \[PDL\], or Intense Pulsed Light \[IPL\]) plus once daily application of oxymetazoline hydrochloride (HCl) cream 1.0%. Oxymetazoline HCL 1.0% Cream: Oxymetazoline HCl cream 1.0% once daily application Energy-Based Therapy: Energy-based therapies (Potassium Titanyl Phosphate \[KTP\], Pulsed Dye Laser \[PDL\], or Intense Pulsed Light \[IPL\])
Overall Study STARTED	46
Overall Study COMPLETED	43
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Oxymetazoline + Energy-Based Therapy Participants will receive energy-based therapy (Potassium Titanyl Phosphate \[KTP\], Pulsed Dye Laser \[PDL\], or Intense Pulsed Light \[IPL\]) plus once daily application of oxymetazoline hydrochloride (HCl) cream 1.0%. Oxymetazoline HCL 1.0% Cream: Oxymetazoline HCl cream 1.0% once daily application Energy-Based Therapy: Energy-based therapies (Potassium Titanyl Phosphate \[KTP\], Pulsed Dye Laser \[PDL\], or Intense Pulsed Light \[IPL\])
Overall Study Adverse Event	3

Baseline Characteristics

Safety and Tolerability of Oxymetazoline and Energy-Based Therapy in Participants With Rosacea

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Oxymetazoline + Energy-Based Therapy n=46 Participants Participants will receive energy-based therapy (Potassium Titanyl Phosphate \[KTP\], Pulsed Dye Laser \[PDL\], or Intense Pulsed Light \[IPL\]) plus once daily application of oxymetazoline hydrochloride (HCl) cream 1.0%. Oxymetazoline HCL 1.0% Cream: Oxymetazoline HCl cream 1.0% once daily application Energy-Based Therapy: Energy-based therapies (Potassium Titanyl Phosphate \[KTP\], Pulsed Dye Laser \[PDL\], or Intense Pulsed Light \[IPL\])
Age, Continuous	51.1 years STANDARD_DEVIATION 12.38 • n=5 Participants
Sex: Female, Male Female	36 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	43 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	46 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	46 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline (Day 1) to Day 56

Population: Safety Population

Outcome measures

Outcome measures
Measure	Oxymetazoline + Energy-Based Therapy n=46 Participants Participants will receive energy-based therapy (Potassium Titanyl Phosphate \[KTP\], Pulsed Dye Laser \[PDL\], or Intense Pulsed Light \[IPL\]) plus once daily application of oxymetazoline hydrochloride (HCl) cream 1.0%. Oxymetazoline HCL 1.0% Cream: Oxymetazoline HCl cream 1.0% once daily application Energy-Based Therapy: Energy-based therapies (Potassium Titanyl Phosphate \[KTP\], Pulsed Dye Laser \[PDL\], or Intense Pulsed Light \[IPL\])
Percentage of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) TEAES	5 Participants
Percentage of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) Treatment Emergent Serious Adverse Events	0 Participants

PRIMARY outcome

Timeframe: Baseline (Day 1) to Day 56

The investigator will assess erythema in the treatment area using a 5-point scale. (Grade 0= Clear Skin with no signs of erythema, Grade 1=Almost clear of erythema, slight redness, Grade 2=Mild erythema, definite redness, Grade 3= Moderate erythema, marked redness, Grade 4=Severe erythema, fiery redness). The percentage of participants with at least a 1-point improvement (decrease) in the score compared to Baseline at any time-point will be reported.

Outcome measures

Outcome measures
Measure	Oxymetazoline + Energy-Based Therapy n=46 Participants Participants will receive energy-based therapy (Potassium Titanyl Phosphate \[KTP\], Pulsed Dye Laser \[PDL\], or Intense Pulsed Light \[IPL\]) plus once daily application of oxymetazoline hydrochloride (HCl) cream 1.0%. Oxymetazoline HCL 1.0% Cream: Oxymetazoline HCl cream 1.0% once daily application Energy-Based Therapy: Energy-based therapies (Potassium Titanyl Phosphate \[KTP\], Pulsed Dye Laser \[PDL\], or Intense Pulsed Light \[IPL\])
Percentage of Participants With at Least a 1-Grade Improvement From Baseline in the Clinical Erythema Assessment Scale at Any Time-point Day 1 -1 hour post dose	8 Participants
Percentage of Participants With at Least a 1-Grade Improvement From Baseline in the Clinical Erythema Assessment Scale at Any Time-point Day 3-Pre Dose	21 Participants
Percentage of Participants With at Least a 1-Grade Improvement From Baseline in the Clinical Erythema Assessment Scale at Any Time-point Day 3-1 hour post dose	37 Participants
Percentage of Participants With at Least a 1-Grade Improvement From Baseline in the Clinical Erythema Assessment Scale at Any Time-point Day 3-3 hour post dose	42 Participants
Percentage of Participants With at Least a 1-Grade Improvement From Baseline in the Clinical Erythema Assessment Scale at Any Time-point Day 3-6 hour post dose	37 Participants
Percentage of Participants With at Least a 1-Grade Improvement From Baseline in the Clinical Erythema Assessment Scale at Any Time-point Day 3 -post dose any hour	43 Participants
Percentage of Participants With at Least a 1-Grade Improvement From Baseline in the Clinical Erythema Assessment Scale at Any Time-point Day 29 Pre Dose	18 Participants
Percentage of Participants With at Least a 1-Grade Improvement From Baseline in the Clinical Erythema Assessment Scale at Any Time-point Day 29-1 hour post dose	14 Participants
Percentage of Participants With at Least a 1-Grade Improvement From Baseline in the Clinical Erythema Assessment Scale at Any Time-point Day 31 Pre Dose	26 Participants
Percentage of Participants With at Least a 1-Grade Improvement From Baseline in the Clinical Erythema Assessment Scale at Any Time-point Day 31 -1 hour post dose	38 Participants
Percentage of Participants With at Least a 1-Grade Improvement From Baseline in the Clinical Erythema Assessment Scale at Any Time-point Day 31-3 hour post dose	39 Participants
Percentage of Participants With at Least a 1-Grade Improvement From Baseline in the Clinical Erythema Assessment Scale at Any Time-point Day 31-6 hour post dose	38 Participants
Percentage of Participants With at Least a 1-Grade Improvement From Baseline in the Clinical Erythema Assessment Scale at Any Time-point Day 31 -any hour post dose	42 Participants
Percentage of Participants With at Least a 1-Grade Improvement From Baseline in the Clinical Erythema Assessment Scale at Any Time-point Day 56 -Pre Dose	30 Participants
Percentage of Participants With at Least a 1-Grade Improvement From Baseline in the Clinical Erythema Assessment Scale at Any Time-point Day 56-1 hour post dose	30 Participants
Percentage of Participants With at Least a 1-Grade Improvement From Baseline in the Clinical Erythema Assessment Scale at Any Time-point Day 56-3 hour post dose	40 Participants
Percentage of Participants With at Least a 1-Grade Improvement From Baseline in the Clinical Erythema Assessment Scale at Any Time-point Day 56 -6 hour post dose	39 Participants
Percentage of Participants With at Least a 1-Grade Improvement From Baseline in the Clinical Erythema Assessment Scale at Any Time-point Day 56 -any hour post dose	40 Participants

PRIMARY outcome

Timeframe: Baseline (Day 1) to Day 56

The investigator will assess the overall severity of telangiectasia (spider veins) on the participant's facing using a 5-point scale where 0=Clear skin with no signs of telangiectasia to 4=Severe, with the presence of many visible telangiectasia. The percentage of participants with at least a 1-point worsening (increase) in the score compared to Baseline at any time-point will be reported.

Outcome measures

Outcome measures
Measure	Oxymetazoline + Energy-Based Therapy n=46 Participants Participants will receive energy-based therapy (Potassium Titanyl Phosphate \[KTP\], Pulsed Dye Laser \[PDL\], or Intense Pulsed Light \[IPL\]) plus once daily application of oxymetazoline hydrochloride (HCl) cream 1.0%. Oxymetazoline HCL 1.0% Cream: Oxymetazoline HCl cream 1.0% once daily application Energy-Based Therapy: Energy-based therapies (Potassium Titanyl Phosphate \[KTP\], Pulsed Dye Laser \[PDL\], or Intense Pulsed Light \[IPL\])
Percentage of Participants With at Least a 1-Grade Worsening From Baseline in the Clinician's Telangiectasia Assessment (CTA) at Any Time-point	3 Participants

Adverse Events

Oxymetazoline + Energy-Based Therapy

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Oxymetazoline + Energy-Based Therapy n=46 participants at risk Participants will receive energy-based therapy (Potassium Titanyl Phosphate \[KTP\], Pulsed Dye Laser \[PDL\], or Intense Pulsed Light \[IPL\]) plus once daily application of oxymetazoline hydrochloride (HCl) cream 1.0%. Oxymetazoline HCL 1.0% Cream: Oxymetazoline HCl cream 1.0% once daily application Energy-Based Therapy: Energy-based therapies (Potassium Titanyl Phosphate \[KTP\], Pulsed Dye Laser \[PDL\], or Intense Pulsed Light \[IPL\])
Skin and subcutaneous tissue disorders Dermatitis Contact	4.3% 2/46 • Number of events 2 • Adverse events were collected from the time the subject signed the informed consent through Day 56 (Exit Visit)
Skin and subcutaneous tissue disorders Rash Papular	2.2% 1/46 • Number of events 1 • Adverse events were collected from the time the subject signed the informed consent through Day 56 (Exit Visit)
Infections and infestations Rash Pustular	4.3% 2/46 • Number of events 2 • Adverse events were collected from the time the subject signed the informed consent through Day 56 (Exit Visit)
Cardiac disorders Tachycardia	2.2% 1/46 • Number of events 3 • Adverse events were collected from the time the subject signed the informed consent through Day 56 (Exit Visit)
General disorders Face Oedema	2.2% 1/46 • Number of events 1 • Adverse events were collected from the time the subject signed the informed consent through Day 56 (Exit Visit)

Additional Information

Dr. David Gordon

Aclaris Therapeutics

Phone: 484-540-6273

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place