Trial Outcomes & Findings for Safety and Efficacy Evaluation of Erbium Treatment (NCT NCT00766376)

Last Updated: 2010-01-29

Results Overview

To assess wrinkle improvement, 3 blinded evaluators use the validated Fitzpatrick Wrinkle Scale (FWS), a 0 to 9 (0=no wrinkles, 9=severe wrinkles) point scale to score the degree of wrinkles, fine lines, and the severity of skin elastosis. Evaluators assign a FWS score to pre-treatment and post-treatment photographs. The difference between the two scores is the amount (i.e., category) of wrinkle improvement. An improvement of one category means a mild improvement in wrinkle reduction.

Recruitment status

UNKNOWN

Study phase

Target enrollment

151 participants

Primary outcome timeframe

participants at three months

Results posted on

2010-01-29

Participant Flow

Participant milestones

Participant milestones
Measure	Erbium Laser Each Subject will undergo 1 - 6 treatment sessions, with 5 scheduled time-points for follow-up visits. Additional follow-up visits may be required to accommodate optional biopsies or to evaluate any concerns related to the course of healing. At each visit, the treated areas will be clinically evaluated and photographed.
Overall Study STARTED	151
Overall Study COMPLETED	124
Overall Study NOT COMPLETED	27

Reasons for withdrawal

Reasons for withdrawal
Measure	Erbium Laser Each Subject will undergo 1 - 6 treatment sessions, with 5 scheduled time-points for follow-up visits. Additional follow-up visits may be required to accommodate optional biopsies or to evaluate any concerns related to the course of healing. At each visit, the treated areas will be clinically evaluated and photographed.
Overall Study Withdrawal by Subject	27

Baseline Characteristics

Safety and Efficacy Evaluation of Erbium Treatment

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Erbium Laser n=124 Participants Each subject will undergo a minimum of 1 treatment with 5 scheduled follow-up visits. Additional follow-up visits may be required to accommodate optional biopsies or to evaluate any concerns related to the course of healing. At each visit, the treated areas will be clinically evaluated and photographed.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	113 Participants n=5 Participants
Age, Categorical >=65 years	11 Participants n=5 Participants
Age Continuous	55 years STANDARD_DEVIATION 8.11 • n=5 Participants
Sex: Female, Male Female	116 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants
Region of Enrollment United States	124 participants n=5 Participants

PRIMARY outcome

Timeframe: participants at three months

Outcome measures

Outcome measures
Measure	Erbium Laser n=151 Participants Each Subject will undergo 1 - 6 treatment sessions, with 5 scheduled time-points for follow-up visits. Additional follow-up visits may be required to accommodate optional biopsies or to evaluate any concerns related to the course of healing. At each visit, the treated areas will be clinically evaluated and photographed.
Number of Participants That Scored Above a One Category (Mild) Improvement Using the Fitzpatrick Wrinkle Scale.	124 Participants

SECONDARY outcome

Timeframe: participants at three months

To assess reductions in pigmented lesions and dyschromia, blinded evaluators were asked to assess pre-treatment and post-treatment photographs. The blinded evaluators were asked to grade percent improvement for pigmentation using a 0 to 10 scale (0=none and 10=severe) and the following quartile improvement scale: 1=1-24%, 2=25-49%, 3=50-74% and 4=75-100%. The blinded-evaluator scores were tabulated and analyzed in order to assess the effects.

Outcome measures

Outcome measures
Measure	Erbium Laser n=151 Participants Each Subject will undergo 1 - 6 treatment sessions, with 5 scheduled time-points for follow-up visits. Additional follow-up visits may be required to accommodate optional biopsies or to evaluate any concerns related to the course of healing. At each visit, the treated areas will be clinically evaluated and photographed.
Number of Participants That Have Reduction in Pigmented Lesions and Dyschromia.	124 Participants

Adverse Events

Erbium Laser

Serious events: 0 serious events

Other events: 124 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Erbium Laser n=124 participants at risk Each Subject will undergo 1 - 6 treatment sessions, with 5 scheduled time-points for follow-up visits. Additional follow-up visits may be required to accommodate optional biopsies or to evaluate any concerns related to the course of healing. At each visit, the treated areas will be clinically evaluated and photographed.
Skin and subcutaneous tissue disorders Petechiae	21.0% 26/124 • Minimum of 3 months post treatment, or until adverse events resolve
Skin and subcutaneous tissue disorders Edema	99.2% 123/124 • Minimum of 3 months post treatment, or until adverse events resolve
Skin and subcutaneous tissue disorders Erythema	100.0% 124/124 • Minimum of 3 months post treatment, or until adverse events resolve
Skin and subcutaneous tissue disorders Bleeding	79.0% 98/124 • Minimum of 3 months post treatment, or until adverse events resolve
Skin and subcutaneous tissue disorders Oozing	57.3% 71/124 • Minimum of 3 months post treatment, or until adverse events resolve
Skin and subcutaneous tissue disorders Skin Texture Changes	7.3% 9/124 • Minimum of 3 months post treatment, or until adverse events resolve
Skin and subcutaneous tissue disorders Bronzing	54.0% 67/124 • Minimum of 3 months post treatment, or until adverse events resolve
Skin and subcutaneous tissue disorders Sloughing	44.4% 55/124 • Minimum of 3 months post treatment, or until adverse events resolve
Skin and subcutaneous tissue disorders Shrinkage	7.3% 9/124 • Minimum of 3 months post treatment, or until adverse events resolve
Skin and subcutaneous tissue disorders Increased Sensitivity	32.3% 40/124 • Minimum of 3 months post treatment, or until adverse events resolve
Skin and subcutaneous tissue disorders Crusting	44.4% 55/124 • Minimum of 3 months post treatment, or until adverse events resolve
Skin and subcutaneous tissue disorders Hyperpigmentation	28.2% 35/124 • Minimum of 3 months post treatment, or until adverse events resolve

Additional Information

Director of Regulatory Affairs

Palomar Medical Technologies, Inc.

Phone: 781-993-2414

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place