Phase
Condition
Alopecia
Hair Loss
Treatment
FoLix treatment for improving the scalp hair appearance
Clinical Study ID
Ages 21-55 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Male and females between 21 - 55 years of age, inclusive. 2. Have FitzpatrickSkin Type V to VI. 3. Have mild to moderate hair loss (Ludwig scale I-II forwomen, Norwood-Hamilton scale I-III for males) 4. Have self-reported thinningor hair loss for more than 6 months prior to screening but less than 5 years.
Clinically confirmed to have hair loss or thinning by the investigator viaphysical exam 6. Didn't receive hair-loss treatments or participated in aclinical study using 1565 NAFL device 7. In good general health, as determinedby the Investigator 8. Willing and able to attend all study visits 9. Willingto maintain the same hair style as at the Screening Visit for the duration ofthe study. If coloring hair, willing to color it with the same frequency ofusage as in the past, making sure not to color within 1-week before and 1-weekafter an in-office appointment 10. Willing to use a mild non-medicated shampooand conditioner for the duration of the study (medicated shampoo andconditioner refer to any prescription shampoo or conditioner as well as anyover-the counter medicated shampoo or conditioner, such as those for treatmentof dandruff or promoting hair growth) 11. Have a negative urine pregnancy testat screening and be using, and continue to use for the duration of the study,an effective contraception method (i.e., abstinence, barrier control,intrauterine device [IUD], or hormonal [estrogen/progestin] contraceptives) forat least one menstrual cycle prior to study; if using IUD or hormonalcontraceptives - then at least 2 years prior to screening, the initiation ofwhich should not have been associated with initiation of hair loss/thinning.
Be willing and able to cooperate with the requirements of the study includingimages taken using a smart camera (multi-spectral) of several skin conditions
Voluntarily sign and date an informed consent agreement approved by theInstitutional Review Board 14. Be able to complete and understand the variousrating instruments in English 15. Sponsor approved global image assessment ofdegree of thinning / hair loss
Exclusion
Exclusion Criteria:
Clinical diagnosis of alopecia areata or scarring forms of alopecia
Patient is of skin type I-IV
Scalp hair loss on the treatment area, due to disease, injury, or medical therapy
Subjects who are pregnant, planning to become pregnant or breastfeeding. A urinepregnancy test will be done to rule out pregnancy. Subjects of childbearingpotential who are not using an approved method of birth control (oralcontraceptives, IUD, contraceptive implant, barrier methods with spermicide orabstinence). Females of non-childbearing potential are defined as postmenopausal (e.g.: absence of menstrual bleeding for one year), hysterectomy or bilateraloophorectomy
Current skin disease (e.g., psoriasis, atopic dermatitis, skin cancer, eczema, sundamage, seborrheic dermatitis), cuts and or abrasions on the scalp or condition (e.g., sunburn, tattoos) on the treatment area that, in the opinion of theInvestigator, might put the subject at risk or interfere with the study conduct orevaluations
Participated in a previous 1565 NAFL study or treatment
History of surgical correction of hair loss on the scalp/ Hair transplants.
Use of any products or devices purported to promote scalp hair growth (e.g.,finasteride or minoxidil) within the 90 days prior to the Baseline Visit.
Use of anti-androgenic therapies (e.g., spironolactone, flutamide, cyproteroneacetate, cimetidine) within 60 days prior to the Baseline Visit.
No history of burning, flaking, itching, and stinging of the scalp.
A chronic condition of high severity dandruff.
History of malignancy (except scc and bcc skin cancers) or undergoing chemotherapyor radiation treatments.
A known history of autoimmune thyroid disease, any other thyroiddisorder/abnormality or other autoimmune disorders that in the opinion of theinvestigator may interfere with the study treatment.
A known history of untreated or uncontrolled depression or bipolar disease or anyother condition that may impact the subject's participation.
Recent utilization of low level lasers for treating hair loss (past 6 months).
Has any condition that the treating investigator or PI thinks may put the Subject atrisk or interfere with their participation in the study.
Is involved in any injury litigation claims.
Known history or recent bloodwork indicating iron deficiency (ferritin level is lessthan 30 ng/mL), bleeding disorders or platelet dysfunction syndrome as well assubjects receiving anticoagulant therapy or smokers with usage >20 cigarettes/day.
Use of any medications that are known to potentially cause hair loss or affect hairgrowth, as determined by PI.
Study Design
Connect with a study center
UnionDerm
New York, New York 10003
United StatesActive - Recruiting
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