A Clinical Study to Evaluate the Efficacy and Safety of Ultra in Promoting Hair Regrowth
ConditionAndrogenic Alopecia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age22-70
SponsorCynosureLutronic
About this trial
The goal of this clinical study is to evaluate the efficacy and safety of the Ultra device for the treatment of hair regrowth by assessing the improvement of hair density and hair shaft diameter.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
22 - 70 years old
Is willing to undergo study device use.
Fitzpatrick skin type I-VI
Clinical diagnosis of androgenetic alopecia (Norwood-Hamilton II-V or Ludwig I-II)
Disqualifiers
Is female and pregnant, has been pregnant within the last 3 months, is currently breast feeding, or planning a pregnancy during the study period.
Has a diagnosis of other forms of alopecia (e.g., scarring alopecia, alopecia areata)
Has recent use (within 6 months) of a systemic hair growth medications (e.g., oral finasteride).
Inconsistent use of vitamins that can affect hair growth - must have stabilized use for at least 6 months prior to first treatment.
Trial design
Design model
Single group
Treatments tested in this trial
Low Level Laser Therapy
DeviceStudy participants received a total of 6 low level laser therapy treatments on their scalp. The treatments occurred 2 weeks apart (+/- 3 days).
Treatment groups
44 Participants
are divided into 1 treatment groupGroup A: Ultra TreatmentExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Difference in the Change in Hair Density from Baseline vs 90-day Follow-up
To evaluate the difference in the change in hair density at baseline vs 90 day follow up in a pre-determined measurement point in the treatment area as measured with a professional dermascope.
Time frame
From baseline (treatment 1) to the 90 day follow up after treatment 6.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov