NCT06003062

Brief Summary

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
25

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2023

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 15, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 21, 2023

Completed
11 days until next milestone

Study Start

First participant enrolled

September 1, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

August 21, 2023

Status Verified

August 1, 2023

Enrollment Period

3 months

First QC Date

August 15, 2023

Last Update Submit

August 15, 2023

Conditions

HirsutismHair Diseases

Keywords

Narcissus Tarzetta Bulb ExtractCannabinoid One (CB1) receptorIBR-DorminHemp-extract

Outcome Measures

Primary Outcomes (2)

  • Hair Follicle Number

    The change in the number of identifable hair follicles using high-power ProScope

    60 days

  • Hair Follicle Diameter

    The change in the hair average hair follicle diameter using high-power ProScope

    60 days

Secondary Outcomes (1)

  • Hair Shaft Color

    60 days

Study Arms (1)

Standard Topical NIghtly Dose

Treatment group

Drug: Narcissus Tazetta Bulb Extract and Novel Hemp Extract

Interventions

Narcissus Tazetta Bulb Extract and Novel Hemp ExtractDRUG

Topical nightly application of phytonutraceutical

Standard Topical NIghtly Dose

Eligibility Criteria

Age18 Years - 100 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsAdult women
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult women with physician-diagnosed hirsutism presenting to a dermatology clinic.

You may qualify if:

  • Physician diagnosed upper lip hirsutism Prior use of therapies to treat the upper lip hirsutism No laser, depilation, or waxing within prior 8 weeks -

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • 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.

    PMID: 21188021BACKGROUND

  • 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.

    PMID: 34363728BACKGROUND

  • 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.

    PMID: 29522176BACKGROUND

MeSH Terms

Conditions

HirsutismHair Diseases

Condition Hierarchy (Ancestors)

Skin DiseasesSkin and Connective Tissue DiseasesVirilismSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Gregory L Smith, MD

CONTACT

4044514045DrSmith@NeX-Therapeutics.com

Shannon Powell, TTS

CONTACT

8132402369Shannon@NeX-Therapeutics.com

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigaor

Study Record Dates

First Submitted

August 15, 2023

First Posted

August 21, 2023

Study Start

September 1, 2023

Primary Completion

December 1, 2023

Study Completion

December 1, 2023

Last Updated

August 21, 2023

Record last verified: 2023-08