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The Therapeutic Blue Shirt trial is not currently running, upcoming trial date TBA
The Skin Institute is recruiting patients to be involved in a clinical study to determine the efficacy and efficiency of Therapeutic Blue Shirts that deliver light to the skin surface for the treatment of body acne.
The Therapeutic Blue Shirts transmit sunlight to the skin surface in the blue spectral range and amplify it by using a proprietary fluorescent dye.
The principle of low-power light acne therapy is based upon a photodynamic therapy (PDT) effect, created in the area that has high bacterial concentration. This effect has been proven in medicine using devices based on filtered lamp radiation and Light Emitting Diodes (LED) technologies.
The specialised fabric of the Therapeutic Blue Shirts has extremely low transmission in the UV range, providing skin protection with SPF of 30.
The clinical study will include 100 to 200 patients who will use the Therapeutic Blue Shirts. This study will be performed in multiple Medical centres throughout the Australian / New Zealand region.
Eligible patients will use the Therapeutic Blue Shirt for a period of up to 60 days.
Patient Selection
Each patient will be evaluated by the investigator to assess his or her suitability for entry into the study.
To be included in the study you need to meet the following criteria:
1.Presence of body acne
2.Skin Type I to VI (Fitzpatrick)
3.Males and females 12 years of age and older
4.Informed consent agreement by the subject, parent or guardian
If you have any of the following, you will not be eligible for the study:
1.Malignant or pre-malignant lesions
2.Known photosensitivity
3.Pregnancy
4.Subjects with Diabetes (Type I or II)
5.Use of medication known to induce photosensitivity
6.Use of Isotretinoin (Accutane®) within the past six months or other topical treatments of body acne within the past two weeks
7.Use of energy based treatments within the past four weeks
Discontinuation
Patients enrolled in the study will be free to discontinue their participation at any time. A decision to discontinue participation will not prejudice their medical care. In those instances, investigators will attempt to obtain clinical results and side-effect evaluation concerning the patient prior to his/her withdrawal.
Procedures
If you are eligible and agree to participate in this study, you will be required to have a minimum of two hours sun exposure per week between the hours of 10 am and 4 pm, over the eight weeks (60 days) of the study. You should not use any other acne treatments on the skin for the period of the study. For areas not covered by the Therapeutic Blue Shirt, such as the face, cleansing soaps, sunscreens or lotions are permitted.
The first visit to the investigator will determine if you are eligible to be in this study. For each treatment session you should wear the Shirt in the sun for at least 15 minutes and for up to 2 hours. You will be asked to provide a detailed medical history (particularly about any medications that affect the skin). You will also have your skin examined to determine what skin type you have and to select the area for the study procedure. Any other treatments for skin disorders are to cease at least two weeks prior to the first treatment with the therapeutic shirt.
Before the treatment protocol begins, digital photographs will be taken of the designated treatment area. Each treatment is performed by you, the patient, without investigator supervision. You should spend a minimum of 15 to 30 hours outside wearing the Shirt over the 60 days of the study period. The longer you spend in the sun wearing the Shirt, the better the result should be.
You will schedule fortnightly appointments with the investigator for evaluation of your treatment results.
Risks And Discomforts
The treatment is extremely safe as you are protected from UV radiation by the Therapeutic Blue Shirt. Any areas not covered by the shirt should be protected by clothing or sun protection lotion with an SPF of 30 or higher.
Benefits
You may or may not experience acne reduction in the area that is treated. Your participation may help to further improve a product for the treatment of acne.
If you are interested and believe you meet the criteria, please send your details to skininfo@skininstitute.co.nz
Please include your name, age, contact details and brief history of your acne condition and/or past treatments.
