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Not yet recruitingNCT06003062Updated Aug 21, 2023

Suppression of Upper Lip Hair Growth Using Novel Hemp Extract

An observational study in Hirsutism and Hair Diseases, sponsored by Medical Life Care Planners, LLC. Not yet recruiting. Open to female participants aged 18 Years to 100 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-08-21.

Sponsored by Medical Life Care Planners, LLC · Observational

From the registry’s dates

  • Primary completion was expected by Dec 2023, 2 years 11 months ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
25
Ages
18 Years to 100 Years
Sex
Female
01

Study 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.

Read the detailed description

Hirsutism is defined as increased bodily and facial hair growth in females presenting in locations where hair is ordinarily minimal or absent. It affects almost 30% of adult females during their lifetime. Current treatments for hirsutism include the use of oral contraceptives or antiandrogens. These drugs and hormones are associated with adverse effects and they may not manifest results if at all for at least 6 months most cannot be used if the female is pregnant, breastfeeding, or trying to become pregnant. Many women find that a multipronged approach that includes direct hair removal (such as plucking, waxing, shaving, depilatories, bleaches and laser), suppression of androgen production with drugs. More recently an effective prescription topical cream, Eflornithine hydrochloride (brand name: Vaniqa) has become available to slow the growth of unwanted facial hair in women. It does not remove hair permanently. Noticeable results take approximately six to eight weeks, and once the cream is discontinued, hair returns to pretreatment levels after approximately eight weeks. Eflornithine cream may cause skin to redden.

Narcissus Tarzetta Bulb Extract 0.02% IBR-Dormin applied topically reduced hair shaft elongation by 34%. The test also showed the hair follicle started the transition from growth to resting phase (telogen). A study of 3.0% topical extract revealed a delay of men's facial hair regrowth after shaving.

Studies of endocannabinoids and phytocannabinoids that stimulate the cannabinoid one (CB1) receptor reveal that topical application inhibited hair shaft elongation and the proliferation of hair matrix keratinocytes, and induced intraepithelial apoptosis and premature hair follicle regression (catagen).

A clinical case series from serial patients with hirsuitism (adult females) at a dermatology clinic will be conducted measuring upper lip hair suppression for cosmetic effects and change in hair shaft count and color. The study will use a topical phytonutraceutical containing Narcissus Tazetta Bulb Extract (0.2%) and a hemp-extract (0.15%) known to stimulate cannabinoid one (CB1) receptors. Based on prior studies the topical will work locally as a locally active topical without systemic absorption.

The 25 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, depilatories, bleaching or tweezing during the duration of the study. Only shaving will be allowed. At the end of the 60-day trial 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-treatment photographs for cosmetic effects, number and thickness of the hairs.

02

Conditions studied

  • Hirsutism
  • Hair Diseases

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Keywords

  • Narcissus Tarzetta Bulb Extract
  • Cannabinoid One (CB1) receptor
  • IBR-Dormin
  • Hemp-extract
03

In context

Hirsutism

41 studies on the registry are indexed under Hirsutism; 8 are open to participants now.

This study's planned enrollment of 25 is below the median of 206 across 14 observational studies indexed under Hirsutism.

Browse Hirsutism studies →

Lead sponsor

Medical Life Care Planners, LLC is the lead sponsor of 5 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 100 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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

-

05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
25 participants (estimated)
Patient registry
No

Groups and cohorts

  • Standard Topical NIghtly Dose

    Treatment group

    Drug: Narcissus Tazetta Bulb Extract and Novel Hemp Extract

Interventions

  • DrugNarcissus Tazetta Bulb Extract and Novel Hemp Extract

    Topical nightly application of phytonutraceutical

06

What researchers measure

Primary outcomes

  1. Hair Follicle Number

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

    Time frame: 60 days

  2. Hair Follicle Diameter

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

    Time frame: 60 days

Secondary outcomes

  1. Hair Shaft Color

    The change in the darkness of the hair follicles will be measured using high-power ProScope

    Time frame: 60 days

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • 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. PubMed 21188021 ↗
  • 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. PubMed 34363728 ↗
  • 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. PubMed 29522176 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 21, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06003062
Lead sponsor
Medical Life Care Planners, LLC
Responsible party
Gregory L Smith, MD, MPH (Principal Investigaor, Medical Life Care Planners, LLC) — Principal investigator
First posted
Aug 21, 2023
Start date
Sep 1, 2023 (estimated)
Primary completion
Dec 1, 2023 (estimated)
Completion
Dec 1, 2023 (estimated)
Last update
Aug 21, 2023

Study contacts

Gregory L Smith, MD
Contact
DrSmith@NeX-Therapeutics.com
4044514045
Shannon Powell, TTS
Contact
Shannon@NeX-Therapeutics.com
8132402369

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.

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