CLEAR + BRILLIANT TOUCH(R) 1440-nm and 1927-nm handpieces. for Solar Elastosis

Phase-Based Estimates
1
Effectiveness
1
Safety
Bausch Site 001, Dallas, TX
CLEAR + BRILLIANT TOUCH(R) 1440-nm and 1927-nm handpieces. - Device
Eligibility
18+
All Sexes
Eligible conditions
Solar Elastosis

Study Summary

This study is evaluating whether a non-ablative fractional laser combination wavelength treatment is safe and effective for general resurfacing of photoaged skin.

See full description

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether CLEAR + BRILLIANT TOUCH(R) 1440-nm and 1927-nm handpieces. will improve 1 primary outcome and 1 secondary outcome in patients with Solar Elastosis. Measurement will happen over the course of 1 month post treatment.

1 month post treatment
Percentage of subjects with improvement in photoaging damage appearance at 1 month post treatment
3 months post treatment
Percentage of subjects with improvement in photoaging damage appearance at 3 months post treatment

Trial Safety

Safety Estimate

1 of 3

Trial Design

2 Treatment Groups

Control
CLEAR + BRILLIANT TOUCH(R) 1440-nm and 1927-nm handpieces

This trial requires 28 total participants across 2 different treatment groups

This trial involves 2 different treatments. CLEAR + BRILLIANT TOUCH(R) 1440-nm And 1927-nm Handpieces. is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

CLEAR + BRILLIANT TOUCH(R) 1440-nm and 1927-nm handpieces
Device
ControlNo treatment in the control group

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 3 months post treatment
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 3 months post treatment for reporting.

Closest Location

Bausch Site 001 - Dallas, TX

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 8 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
The patient has no more than a mild to moderate classification on the Glogau Photodamage Scale. show original
Fitzpatrick skin types are numbered from I to VI, with I being the lightest and VI the darkest. show original
The Fitzpatrick wrinkle and elastosis scale classifies wrinkles and elastosis on a scale from 1 to 6, with 1 being fine wrinkles and mild elastosis and 6 being deep wrinkles and severe elastosis. show original
The ability to read, understand, and sign the informed consent form is necessary in order to participate in the study. show original
Do not take any new medications (unless prescribed by the study investigator) or undergo any other procedures that may potentially treat photodamaged skin (any other aesthetic treatments) during the study. show original
Male or female.
People aged 18 to 65. show original
The patient must be told of the risks and benefits of the proposed treatment show original

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many people get solar elastosis a year in the United States?

Add answer

The current prevalence of solar elastosis is roughly 15% of all skin conditions; but it is still not a widely identified condition and its exact prevalence is unknown. A detailed prevalence study is needed to document the incidence, nature, and severity of solar elastosis; to find its aetiology and treatment; and to formulate public awareness and prevention programmes.

Unverified Answer

What are the signs of solar elastosis?

Add answer

The appearance of solar elastosis in childhood and early adulthood is characterized by a gradual onset and progression of pale skin from the back of the arms and hands to the cheeks, and a gradual change in height. This change in skin pigmentation from red to pale can appear in just a few days.\n

Unverified Answer

What causes solar elastosis?

Add answer

In this small series, the solar elastosis condition was diagnosed only in patients who had light-mediated damage to the skin from the prolonged exposure to sunlight, a process that may be triggered by sunburn, sun-induced inflammation and photoaging through photo-damage and chronic inflammation in individuals of Northern European descent. In order to avoid excessive photobiological damage, sunlight and sunlight-induced inflammation should be used wisely to protect the skin from solar elastosis.

Unverified Answer

What is solar elastosis?

Add answer

Solar elastosis is a well known skin anomaly characterized by hard pigmented papules in sun-exposed areas resulting from reduced elasticity and diminished pigmentation of the skin in response to UVA radiation. It may be associated with the Wnt and Toll-like receptor pathways and the immune system.

Unverified Answer

Can solar elastosis be cured?

Add answer

Solar elastosis was seen to heal after solar elastosis treatment in this small series. Solar elastosis has the potential to be a useful treatment for those with solar elastosis.

Unverified Answer

What are common treatments for solar elastosis?

Add answer

There are many treatments available for solar elastosis, such as protective glasses, sunscreen, cryotherapy (cooling with liquid nitrogen gas or ice cream), or surgical treatments, such as laser surgery or dermabrasion.

Unverified Answer

What is the average age someone gets solar elastosis?

Add answer

Sun-Protection Education can prevent sunburn during outdoor activities and decrease chronic sun exposure over a lifetime. However, it is still uncertain what the average age is for Solar Elastosis in the United States. Please see the "Find a Clinical Trial" section above to find the appropriate clinical trial for your situation.

Unverified Answer

Have there been other clinical trials involving clear + brilliant touch(r) 1440-nm and 1927-nm handpieces.?

Add answer

Current clinical research results in the use of a handpiece based on the technology of solar elastosis for transoral (head and neck) therapy of diseases like cancers and vascular diseases. The data of these ongoing trials should be evaluated at the beginning of the first treatments. In the further development, the use of this type of handpiece should also be investigated in relation to the use of the same device in conjunction with other conventional therapeutic modalities.

Unverified Answer

What is clear + brilliant touch(r) 1440-nm and 1927-nm handpieces.?

Add answer

Clinicians may be unable to identify an intraoperatively used handpiece based solely upon the wavelength of the lamp. Careful use of the Clear Plus handpiece in these settings may help ensure the correct wavelengths of the handpiece are used to prevent excessive blood loss. However, using 2 LED handpieces is the best procedure for ensuring that proper wavelengths are being used and thus, preventing excessive blood loss.

Unverified Answer

What is the primary cause of solar elastosis?

Add answer

The solar elastosis seen in the present case does not seem to coincide with any other type of solar elastosis described by the authors before and we therefore question whether there are any genetic influences on the development of solar elastosis.

Unverified Answer

What are the common side effects of clear + brilliant touch(r) 1440-nm and 1927-nm handpieces.?

Add answer

When comparing the two handpieces, we found that the clear + brilliant touch(r) 1440-nm handpiece generated fewer complaints of dryness and itching or irritation than the 1927-nm handpiece. Skin changes, including lightening, and pigment changes were also less common with the clear + brilliant touch(r) 1400-nm handpiece, compared with the 1927-nm handpiece, although they did occur.

Unverified Answer

Does solar elastosis run in families?

Add answer

Data from a recent study support the hypothesis that the solar elastosis trait may be a genetically inherited condition. Further study is required to determine the precise mechanism by which this trait may be triggered and passed on. Once the underlying genetic defect has been determined, it may be possible to develop new treatment strategies for this disease.

Unverified Answer
See if you qualify for this trial
Get access to this novel treatment for Solar Elastosis by sharing your contact details with the study coordinator.