The goal of this clinical trial was to learn if a novel laser device works as well and is as safe as an already approved laser device for removing freckles on the face. The main questions it aimed to answer were: After 8 weeks, did the novel laser make freckles fade by 60% or more for a similar number of participants as the approved laser? What side effects did participants have from either laser? Researchers compared the results from two sides of each participant's face to see if the novel laser worked as well as the approved laser. One side of the face was treated with the novel laser, and the other side was treated with the approved laser. A computer randomly chose which side received which laser. Participants in this study: Were adults (aged 18-65) with similar freckles on both sides of their face. Received one laser treatment session, using the two different lasers on opposite sides of their face. Returned to the clinic for check-up visits about 4 weeks and 8 weeks after the treatment. Had photos taken of their face at each visit so doctors could compare the fading of their freckles. Answered questions about any pain during the treatment and their satisfaction with the results.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
84
This is an investigational medical device. It is a Nd:YAG laser system that generates picosecond-duration pulses of light at a wavelength of 532 nanometers (nm). It is designed for the treatment of benign epidermal pigmented lesions, including freckles, through selective photothermolysis and photomechanical effects.
This is a marketed (approved) medical device used as an active comparator. It is a Nd:YAG laser system that generates picosecond-duration pulses of light at a wavelength of 532 nanometers (nm). It is indicated for the treatment of benign epidermal pigmented lesions, including freckles.
Bengbu First People's Hospital
Bengbu, Anhui, China
Beijing Hospital
Beijing, China
Treatment Response Rate at 8 Weeks
The proportion of participants achieving a treatment response at the 8-week follow-up visit. A response is defined as a lesion clearance rate of 60% or greater. The clearance rate is calculated as: \[(Number of freckles at baseline - Number of freckles at 8 weeks) / Number of freckles at baseline\] x 100%. Assessment is performed by blinded evaluators based on standardized photographs.
Time frame: 8 weeks after the single treatment session
Complete Clearance Rate at 8 Weeks
The proportion of participants achieving complete clearance of freckles at the 8-week follow-up visit. Complete clearance is defined as a lesion clearance rate of 90% or greater. The clearance rate is calculated as: \[(Number of freckles at baseline - Number of freckles at 8 weeks) / Number of freckles at baseline\] x 100%. Assessment is performed by blinded evaluators based on standardized photographs.
Time frame: 8 weeks after the single treatment session
Global Aesthetic Improvement Scale (GAIS) Score at 8 Weeks
The overall improvement in aesthetic appearance of the treated areas as assessed by blinded evaluators at the 8-week follow-up visit, using the Global Aesthetic Improvement Scale (GAIS). The GAIS is a 5-point scale ranging from 1 (Worse) to 5 (Very Much Improved).
Time frame: 8 weeks after the single treatment session
Pain Score During Treatment (VAS)
The level of pain experienced by participants during the laser treatment, assessed immediately (within 30 minutes) after the treatment using a Visual Analogue Scale (VAS). The VAS is a continuous scale ranging from 0 (no pain) to 10 (worst pain imaginable).
Time frame: Immediately after the single treatment session (within 30 minutes)
Participant Satisfaction Score at 8 Weeks
The degree of participant satisfaction with the treatment results regarding pigment clearance, assessed at the 8-week follow-up visit using a satisfaction survey. The score ranges from 1 (completely dissatisfied) to 5 (very satisfied).
Time frame: 8 weeks after the single treatment session
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