ABSTRACT
UNLABELLED: BACKGROUND Female pattern hair loss (FPHL) is a common hair disorder that affects millions of women. A new 5% minoxidil topical foam (MTF) formulation, which does not contain propylene glycol, has been developed.
OBJECTIVE: To compare the efficacy and safety of once-daily 5% MTF with vehicle foam for the treatment of FPHL.
MATERIALS AND METHODS: This was a Phase III, randomized, double-blind, vehicle-controlled, parallel-group, international multicenter trial (17 sites) in women aged at least 18 years with FPHL (grade D3 to D6 on the Savin Density Scale), treated once daily with 5% MTF or vehicle foam for 24 weeks. The co-primary efficacy endpoints were the change from baseline at week 24 in target area hair count (TAHC) and subject assessment of scalp coverage. Also evaluated were TAHC at week 12, expert panel review of hair regrowth at week 24, and change from baseline in total unit area density (TUAD, sum of hair diameters/cm2) at weeks 12 and 24.
RESULTS: A total of 404 women were enrolled. At 12 and 24 weeks, 5% MTF treatment resulted in regrowth of 10.9 hairs/cm2 and 9.1 hairs/cm2 more than vehicle foam, respectively (both P<.0001). Improved scalp coverage at week 24 was observed by both subject self-assessment (0.69-point improvement over vehicle foam; P<.0001) and expert panel review (0.36-point improvement over the vehicle foam; P<.0001). TUAD increased by 658 μm/cm2 and 644 μm/cm2 more with 5% MTF than with vehicle foam at weeks 12 and 24, respectively (both P<.0001). MTF was well tolerated. A low incidence of scalp irritation and facial hypertrichosis was observed, with no clinically significant differences between groups.
CONCLUSION: Five percent MTF once daily for 24 weeks was well tolerated and promoted hair regrowth in women with FPHL, resulting in improved scalp coverage and increased hair density compared with vehicle foam. ClinicalTrials.gov identifier: nCT01226459
J Drugs Dermatol. 2016;15(7):874-881.
Subject(s)
Alopecia/diagnosis , Alopecia/drug therapy , Minoxidil/administration & dosage , Minoxidil/chemistry , Administration, Topical , Adult , Aged , Dermatitis, Irritant/diagnosis , Dermatitis, Irritant/etiology , Double-Blind Method , Drug Compounding , Female , Humans , Middle Aged , Minoxidil/adverse effects , Treatment OutcomeABSTRACT
BACKGROUND: A once-daily minoxidil topical foam (MTF) has been developed to treat female pattern hair loss.
OBJECTIVE: Determine noninferiority of once-daily 5% MTF versus twice-daily 2% minoxidil topical solution (MTS) based on the change from baseline in target area hair count (TAHC) at 24 weeks. METHODS: In a randomized, phase III trial, women with female pattern hair loss received once-daily 5% MTF (n=161) or twice-daily 2% MTS (n=161) for 52 weeks. Primary endpoint was change from baseline in TAHC at 24 weeks. Secondary endpoint was change from baseline in TAHC at 12 weeks. Exploratory endpoints included change in total unit area density and change in overall scalp coverage.
RESULTS: Once-daily 5% MTF increased TAHC from baseline (adjusted mean ± standard error) by 23.9 ± 2.1 hairs/cm2 at week 24. Twice-daily 2% MTS increased TAHC 24.2 ± 2.1 hairs/cm2 at week 24. The treatment difference was -0.3 hairs/cm2 (95% CI = -6.0, 5.4). Since the lower bound of the 95% CI was less than -5.0, the prespecified noninferiority goal was not met. Both treatments were well tolerated.
CONCLUSIONS: Once-daily 5% MTF and twice-daily 2% MTS induced hair regrowth in female pattern hair loss, but prespecified noninferiority criteria were not met.
ClinicalTrials.gov identifier: NCT01145625
J Drugs Dermatol. 2016;15(7):883-889.
Subject(s)
Alopecia/diagnosis , Alopecia/drug therapy , Minoxidil/administration & dosage , Minoxidil/chemistry , Adult , Aged , Dermatitis, Irritant/diagnosis , Dermatitis, Irritant/etiology , Drug Administration Schedule , Drug Compounding , Female , Humans , Middle Aged , Minoxidil/adverse effects , Pharmaceutical Solutions/administration & dosage , Pharmaceutical Solutions/adverse effects , Pharmaceutical Solutions/chemistry , Single-Blind Method , Treatment OutcomeABSTRACT
PURPOSE: To evaluate the clinical safety and comfort of a new benzalkonium chloride-free Visine(®) lubricant eye drop formulation (Hydroblend™ and GentlePur™) in healthy and dry eye subjects. METHODS: This was a single-site, open-label clinical study comprised of 22 healthy and 22 dry eye subjects. Subjects were instructed to instill 1-2 drops of the test product four times a day for 2 weeks and were examined at visit 1 (day 0), visit 2 (day 7), and visit 3 (day 14). Assessments at each visit included postdosing product usage comfort scores, predosing fluorescein corneal staining score, predosing visual acuity, and pre- and postdosing ocular structure change using slit-lamp biomicroscopy. Adverse events were monitored throughout the course of the study. RESULTS: Throughout the 14 days of the trial period, subjects from both healthy and dry eye groups rated the eye drops as "very comfortable". For dry eye group, the mean product usage comfort scores for the first 3 minutes postdosing ranged from 8.5 to 8.8 at visit 1 and 9.2 to 9.6 at visit 3 on a 0-10 point scale, with 0 being very uncomfortable and 10 being very comfortable. The mean corneal staining scores over five corneal regions changed from 0.65 at visit 1 to 0.39 at visit 3 for dry eye group. The individual region corneal staining scores were also decreased from visits 1 to 3 for dry eye group. All subjects maintained pretreatment means visual acuity at visits 2 and 3. Biomicroscopic examination indicated no structural changes at all visits. There were no significant adverse events reported during the course of the study. CONCLUSION: The study confirms that GentlePur™ is an appropriate choice as a preservative for ocular application. The new formulation was safe and comfortable when used four times a day in healthy and dry eye subjects.
