Phase 3 N=20 Randomized Double-blind Treatment

Comparison of Efficacy, Safety and Tolerability of Two Different 810 nm Diode Lasers for Hair Reduction

Hypertrichosis

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View on ClinicalTrials.gov: NCT01212172 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Feb 2016

Primary outcome: Primary: Change in Hair Growth — 57.6; 52.1; 39.3; 29.9 % hair reduction — p=0.2879

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Soprano/SHR (Device); LightSheer (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of California, Irvine
Primary completion: Sep 2013

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Hair Growth	57.6; 52.1; 39.3; 29.9; 47.5; 44.7	0.2879
SECONDARY Pain Rating Scale	3.6; 2.7	—

Summary

The purpose of this research study is to compare two different 810 diode laser systems (Soprano XL (SHR Mode)and Light Sheer Duet) for laser hair removal. The goal is to determine if each laser system is effective at reducing the amount of hair on the lower legs or the axilla (arm pit). Another goal is determine the subject's perspective on the treatment including tolerability and effectiveness.

Eligibility Criteria

Inclusion Criteria

Subjects must be at least 18 years of age.
Subjects must be in reasonably good health as defined by the Investigator.
Subject agrees to avoid tanning during their participation in this trial.
Subject has Fitzpatrick skin types I-V and dark brown hair.
Subjects must agree to avoid shaving legs less than 72 hours prior to a study visit.
Subjects have indicated willingness to participate in the study by signing an informed consent document.

Exclusion Criteria

Subject is pregnant, lactating, or planning to get pregnant within the study period.
Subject is unwilling to use birth control during the study period if of child bearing age.
Subject has a known history of photosensitivity or use of medication with photosensitizing properties.
Subject has skin disease on exam at screening.
Subject has history or evidence of any chronic or reoccurring skin disease or disorder(e.g., psoriasis, Netherton syndrome, etc.) affecting the treatment area.
Subject has a history of keloid or hypertrophic scar formation.
Subject has a tattoo in the treatment area.
Subject has been tanning within the past 30 days.
Subject has history of confounding cancerous or pre-cancerous skin lesions in the treatment area.
Subject has used prohibited therapies (electrolysis, threading, waxing, depilatory), prohibited oral prescription medications (isotretinoin, steroids), or prohibited topical meds (steroids) on the treatment area within 30 days prior to enrollment.
Subject is unwilling to discontinue use of above listed prohibitive therapies for the duration of treatment.
Subject has a history of laser hair removal in the treatment area.
Subject has participated in any clinical trial involving an investigational drug or cosmetic product or procedure within the past 30 days.
The investigator feels that for any reason the subject is not eligible to participate in the study.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01212172). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.