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New treatment option for Frontal Fibrosing Alopecia
Official title Facial Papules in Frontal Fibrosing Alopecia (FFA)
ClinicalTrials.gov ID: NCT07340671
What this study is testing
- What it's testing
- The objective is to evaluate the safety and efficacy of the Cutera 1726 nm laser system (also referred to as AviClear) for the treatment of facial papules in frontal fibrosing alopecia (FFA).
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Female or Male
- Fitzpatrick Skin Types I-VI
- At least 18 years of age
- Has clinically diagnosed FFA with facial papules.
- Subject must be able to read, speak, and understand English or Spanish and sign the Informed Consent Form.
You likely can't join if
- Prior treatment to the target area during participation in a clinical trial of another device or drug within 1 month (30 days) prior to study...
- Prior treatment to the target area within 3 months of study participating including chemical peel, dermabrassion, microneedling, radiofrequency...
- Prior injection of botulinum toxin in the target area within 3 months of study participation and for the duration of the study.
- Systemic use of retinoid, such as isotretinoin, within 3 months of study participation.
- Still healing from another treatment in the target area according to investigator's discretion.
- History of malignant tumors in the target area.
See the full eligibility criteria
- Female or Male
- Fitzpatrick Skin Types I-VI
- At least 18 years of age
- Has clinically diagnosed FFA with facial papules.
- Subject must be able to read, speak, and understand English or Spanish and sign the Informed Consent Form.
- Willing and able to adhere to the treatment and follow-up schedule and pre/post-treatment care instructions.
- No contraindication to laser therapy.
- Willing to have photographs taken of the treatment area and agree to the use of photographs for presentation, educational or marketing purposes.
- Agree to not undergo any other procedure(s) or add any new treatment modalities in the treatment area during the study.
- Willing to use investigator approved skincare topicals and follow investigator approved skincare regimen for the duration of the study.
- Prior treatment to the target area during participation in a clinical trial of another device or drug within 1 month (30 days) prior to study participation.
- Prior treatment to the target area within 3 months of study participating including chemical peel, dermabrassion, microneedling, radiofrequency treatment, laser or light-based procedures, cryodestruction or...
- Prior injection of botulinum toxin in the target area within 3 months of study participation and for the duration of the study.
- Systemic use of retinoid, such as isotretinoin, within 3 months of study participation.
- Still healing from another treatment in the target area according to investigator's discretion.
- History of malignant tumors in the target area.
- Pregnant and/or breastfeeding or planning to become pregnant during the study.
- History of diagnosed immunosuppression/immune deficiency or currently using immunosuppressive medications.
- History of diagnosed connective tissue disease, such as systemic lupus erythematosus or scleroderma.
- Any use of medication that is known to increase sensitivity to light according to Investigator's discretion.
- History of disease stimulated by heat, such as recurrent herpes simplex and/or herpes zoster (shingles) in the target area, unless treatment is conducted following a prophylactic regimen.
- History of radiation to the target area, currently undergoing treatment for skin cancer in the target area, or undergoing systemic chemotherapy for the treatment of cancer.
- History of diagnosed pigmentary disorders (including vitiligo) in the target area.
- Excessively tanned in the treatment area or unable/unlikely to refrain from tanning in the target area during the study.
- History of keloids or hypertrophic scarring.
- Prisoners
- As per the Investigator's discretion, any physical, mental or medical condition which might make it unsafe for the subject to participate in this study, might interfere with patient's participation in the full study...
The study team makes the final eligibility decision.
Where it's taking place
- Miami, Florida, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Miami, Florida, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.