Hirsutism Clinical Trial
Official title:
Suppression of Upper Lip Hair Growth Using Novel Hemp Extract - A Case Series
A clinical case series will be conducted measuring upper lip hair suppression for cosmetic effects in a group of 25 adult women with hirsutism of the upper lip. The study will use a topical phytonutraceutical that contains two ingredients that have been shown to suppress hair growth. The serum contains Narcissus Tazetta Bulb Extract (0.2%) and a hemp-extract (0.15%) known to stimulate cannabinoid one (CB1) receptors. The subjects will use the serum nightly for 60 days. High-power ProScope photographs will be obtained at the philtrum (above the center of the upper lip) as a landmark. Prior to starting the serum subjects will grow their upper lip hair for seven days. Hair shafts will be counted and graded for thickness and color using a standard methodology. The subjects will then use the serum for 60 days and will not be allowed to use laser, waxing, bleaching or tweezing during the duration of the study. Only shaving will be allowed. At the end of the 60 day course the subjects will grow their lip hair for seven days and the high-power photographs will be repeated at the same location based on landmarks. An independent board-certified dermatologist will evaluate and grade the pre- and post- serum photographs for cosmetic effects, number and thickness of the hairs.
Status | Not yet recruiting |
Enrollment | 25 |
Est. completion date | December 1, 2023 |
Est. primary completion date | December 1, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 100 Years |
Eligibility | Inclusion Criteria: Physician diagnosed upper lip hirsutism Prior use of therapies to treat the upper lip hirsutism No laser, depilation, or waxing within prior 8 weeks - Exclusion Criteria: Local infection near or at application site. Local skin irritation or ulceration near or at application site. Inability to be available for entire duration of study and in-person photographs - |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Medical Life Care Planners, LLC |
Barrionuevo P, Nabhan M, Altayar O, Wang Z, Erwin PJ, Asi N, Martin KA, Murad MH. Treatment Options for Hirsutism: A Systematic Review and Network Meta-Analysis. J Clin Endocrinol Metab. 2018 Apr 1;103(4):1258-1264. doi: 10.1210/jc.2017-02052. — View Citation
Gupta AK, Talukder M. Cannabinoids for skin diseases and hair regrowth. J Cosmet Dermatol. 2021 Sep;20(9):2703-2711. doi: 10.1111/jocd.14352. Epub 2021 Aug 7. — View Citation
Kopera D, Wehr E, Obermayer-Pietsch B. Endocrinology of hirsutism. Int J Trichology. 2010 Jan;2(1):30-5. doi: 10.4103/0974-7753.66910. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Hair Follicle Number | The change in the number of identifable hair follicles using high-power ProScope | 60 days | |
Primary | Hair Follicle Diameter | The change in the hair average hair follicle diameter using high-power ProScope | 60 days | |
Secondary | Hair Shaft Color | The change in the darkness of the hair follicles will be measured using high-power ProScope | 60 days |
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