Rosacea Clinical Trial
Official title:
Treatment of Dilated Blood Vessels on the Cheeks With a New Yellow Laser and a Traditional Green Laser
NCT number | NCT03472859 |
Other study ID # | R17111 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | October 1, 2017 |
Est. completion date | June 9, 2018 |
Verified date | February 2018 |
Source | Tampere University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The goal is to compare a novel yellow laser, based on semiconductor technology, with traditional green laser, in the treatment of cheek telangiectasias. The trial design is randomized split-face double-blinded study with 20-30 volunteers. The improvement will be assessed using a 7-point Telangiectasia Grading Scale.
Status | Completed |
Enrollment | 24 |
Est. completion date | June 9, 2018 |
Est. primary completion date | June 9, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - The subjects are required to be Finnish speaking adults with symmetrical facial telangiectasia, volunteering to participate in the clinical trial. - The subjects have to have a Fitzpatrick skin phototype I-IV. Exclusion Criteria: - pregnancy - lactation - hemophilic condition - Fitzpatrick skin phototype V-VI - drug or alcohol abuse - subjects who are under guardianship - subjects with significant tanning less than 6 weeks prior to the treatment day. - unbalanced basic diseases, such as diabetes, heart disease, cancer etc. |
Country | Name | City | State |
---|---|---|---|
Finland | Epilaser Oy | Lempäälä | Pirkanmaa |
Lead Sponsor | Collaborator |
---|---|
Tampere University Hospital | Tampere University of Technology |
Finland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | TGS change | Telangiectasia grading scale will be used to assess improvement of telangiectasia and erythema. The range of TGS is -1 to 5, where -1 means worsening of the condition, 0 means no change, 1 means 0-25% improvement, 2 means 25-50% improvement, 3 means 50-75% improvement, 4 means 75-100% improvement and 5 means total clearance. | Before treatment and 1-2 months after the intervention. | |
Secondary | VAS pain measurement | Visual Analogue Scale will be used to measure the amount of pain after the intervention. The range is 0.0 - 10.0, where 0 means no pain and 10 means worst imaginable pain. The results will be reported as a mean value and range for yellow laser and green laser separately. | Immediately after intervention. | |
Secondary | Amount of treatment-related adverse effects using a 4-point scale. | The amount of erythema, crusting, edema, purpura and blisters will be assessed separately on both sides of the face. The measurement range is 0-3, where 0 means no symptoms, 1 means mild symptoms, 2 means moderate symptoms and 3 means severe symptoms. The results will be reported as a mean value for yellow laser and green laser separately. | Immediately after treatment and 2-3 days after treatment. |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05597462 -
Impact of DFD-29 on Microbial Flora of Healthy, Adult Human Subjects When Administered Over 16 Weeks
|
Phase 1 | |
Completed |
NCT02601963 -
Safety and Efficacy Study of a Topical Minocycline Foam in Patients With Papulopustular Rosacea
|
Phase 2 | |
Completed |
NCT02249065 -
Mirvaso in Use Study
|
Phase 4 | |
Completed |
NCT02292797 -
Assessment of the Rosacea Prevalence in the General Population
|
N/A | |
Completed |
NCT01659853 -
Efficacy and Safety Study Comparing CD07805/47 Gel 0.5% to Azelaic Acid Gel 15% in Subjects With Erythema of Rosacea
|
Phase 3 | |
Completed |
NCT01426269 -
Evaluation of Relapse, Efficacy and Safety of Long-term Treatment With Oracea® vs Placebo
|
Phase 4 | |
Completed |
NCT00991198 -
The Role of Topically Dissolved Oxygen (TDO) to Ameliorate Signs of Photodamage
|
Phase 2 | |
Terminated |
NCT04336163 -
Skin Imaging to Inform Laser Treatments
|
N/A | |
Recruiting |
NCT04108897 -
Analysis of the Microbiome in Rosacea
|
Early Phase 1 | |
Completed |
NCT03872050 -
Deep Phenotyping of Rosacea and Migraine
|
||
Active, not recruiting |
NCT06033352 -
Potassium-titanyl Phosphate (KTP) Laser vs KTP Laser and Ivermectin Cream for Facial Rosacea
|
Phase 2 | |
Completed |
NCT03263273 -
Study to Evaluate the Safety and Efficacy of Topical Minocycline Gel in Patients With Papulopustular Rosacea
|
Phase 2 | |
Completed |
NCT04508205 -
CGB-400 for the Reduction of Facial Redness and Bumps and Blemishes
|
Phase 1 | |
Completed |
NCT04508660 -
CGB-400 for the Reduction of Facial Redness
|
Phase 1 | |
Completed |
NCT05094700 -
A Study of a Polymeric Surfactant Technology Cleanser in Sensitive Skin Participants
|
N/A | |
Active, not recruiting |
NCT03211585 -
EVALUATION OF THE EFFECT OF THE PERFECTA V-BEAM LASER ON ROSACEA
|
N/A | |
Completed |
NCT02637232 -
Mirvaso® Utilisation and Patient Satisfaction Evaluation (MUSE)
|
||
Completed |
NCT02576860 -
Study to Evaluate the Safety and Efficacy of a Once-Daily CLS001 Topical Gel Versus Vehicle
|
Phase 3 | |
Completed |
NCT02576847 -
Study to Evaluate the Long-term Safety of a Once-Daily Omiganan Topical Gel
|
Phase 3 | |
Completed |
NCT02583009 -
A Study to Evaluate the Safety and Efficacy of PAC-14028 Cream in Rosacea
|
Phase 2 |