Theradome is effective on all hair colors. Regarding skin color, we do not currently have documented clinical trials for the darkest skin tone shades on the Fitzpatrick scale, or skin tones in ranges 5 & 6. The reason is simply because we lacked the necessary subjects in our last clinical study. We only had 13 participants with darker skin tone. The FDA would not allow us to include the higher end of the pigment chart without a minimum number of 22 people. This clinical study was conducted in an area that had a low demographic of darker skinned people.
The good news is that subjects with darker pigmentation have experienced better results with Theradome. This is due to the fact darker tones absorb laser light more readily. In fact, our CEO and inventor of the Theradome helmet has a medium to dark complexion. Additionally, many of our testimonials come from darker-skinned customers.
Theradome is specifically designed for treating Androgenetic Alopecia and we are not FDA cleared or have tested it for the following conditions:
Alopecia areata totalis
Frontal fibrosing alopecia
Central centrifugal cicatricial alopecia
Hair shaft abnormalities
Loose anagen syndrome
Trichotillomania (regrowing only)
Dissecting cellulitis of the scalp
Discoid lupus erythematosus
Chemo Induced Alopecia
We have had many customers use our device to help with some of these conditions. We have had had reports of success with Alopecia Areata, Chemo Induced Alopecia and Frontal fibrosing Alopecia. These reports were from from individual customers and not from any clinical studies that Theradome had conducted. Therefore we suggest working with your physician to discuss treatments for conditions outside of Androgenetic Alopecia.
Our Theradome does not interfere with any light sensitive medications including Salicylic Acids/Alpha Hydroxy Acid (Ahas) and other light sensitive medications since the Theradome operates in the near infrared spectrum. Whereas light sensitive medications are sensitive to Ultraviolet wavelengths.
Frontal fibrosing alopecia (FFA) is a form of lichen planopilaris. The Theradome has not been tested or FDA cleared for Lichen Planopilarus (LP) but we have had many professional trichologists and dermatologists prescribe the Theradome to their LP patients. Since LP is inflammatory scalp condition, and we believe that laser phototherapy (LPT) (e.g. Theradome) are beneficial since LPT has been clinically proven to reduce inflammation and prevent further damage from the devasting effect of LP if used regularly. We always suggest that you consult with your physician or trichologists if the Theradome is right for you. Please note that the Theradome is a very new modality and many physicians and trichologists are not familiar with our device therefore, please have them contact us if they require additional clinical information that might assist them.
The fact is red light therapy does not affect any implants, plates or meshes which are placed in the cranium. Since red light does not have any heat associated with the delivery of the light dosage into the human tissue, there is no possibility of the red light negatively reacting with the mesh in this case. The Theradome lasers are only designed to focus on hair follicles.
The Theradome has not been tested on scalps with scalp cancer which are usually in the form of lesions, masses, lumps and tumors.
Over exposure to the sun can cause Actinic Keratosis and is very different in appearance than bonafide scalp cancer. They rarely turn into fully fledged skin cancer but some physicians do take extreme precautions by removing them.
Since Theradome has not been tested on patients with Actinic Keratosis. We would err on the side of caution and suggest that you consult with your physician. Please note that all Actinic Keratosis lesions are caused by UV Ultraviolet waves. Theradome does not emit any UV waves.
The Theradome only emits near infrared waves which have absolutely no negative side effects to the human skin. We have not submitted for FDA for clearance to assist patients with Actinic Keratosis or scalp cancers.
Seborrheic Keratosis is a non-cancerous skin growth and are more common as people age. Since this is a non-cancerous anomaly, then there will be no issues using the Theradome.
The only contraindication related to skin lesions and using the Theradome is if someone has verified cancerous lesion or melanoma. We have never tested or seeked FDA clearance for known cancerous/melanoma lesions and usage of the Theradome and therefore we cannot recommend it either way. Even though there are new laser based products (non Theradome) specifically designed to treat cancerous lesions with red laser light with great success. But since we have not tested it ourselves we cannot endorse using it if you have a verified melanoma or cancerous growth. But again, Seborrheic keratosis is a non-cancerous lesion and not a melanoma and you are free to use the Theradome with no issues.
Theradome is FDA cleared for Androgenetic Alopecia. However we have reported from physicians and cancer patients who have used the Theradome for Chemotherapy Induced Cancer Alopecia (CIA). Often CIA is due to various classes of medicine including taxanes, docetaxel, anthracyclines, palbociclib (ibrance), letrozole and more.
These medications are designed to target all rapidly dividing cells such as hair and thereby the side effect is hair loss. Some women do not recover from Cancer Induced Alopecia loss due to the dosage or intensity of the chemotherapy treatments. Theradome has been reported to grow back the hair much faster and healthier. The Theradome has zero side effects. We are not cleared by the FDA to market this device for Cancer Induced Alopecia. We encourage you to consult with your oncologist or physician on your options. Theradome is a new modality. We would be happy to provide your physician any clinical data and support should they ask any questions.