HirsutismNCT06003062
Suppression of Upper Lip Hair Growth Using Novel Hemp Extract
An observational study of Hirsutism and Hair Diseases, run by Medical Life Care Planners, LLC.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Hirsutism, Hair Diseases
- What is being tested?
- Narcissus Tazetta Bulb Extract and Novel Hemp Extract
- How many people
- 25 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2023to 1 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adult women with physician-diagnosed hirsutism presenting to a dermatology clinic.
Who may be able to join
- Physician diagnosed upper lip hirsutism Prior use of therapies to treat the upper lip hirsutism No laser, depilation, or waxing within prior 8 weeks -
Who cannot join
- 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
- -
Trial locations and contacts
No sites are listed yet.
About this study
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.
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.
- Conditions
- Hirsutism, Hair Diseases
- Being tested
- Narcissus Tazetta Bulb Extract and Novel Hemp Extract
- Keywords
- Narcissus Tarzetta Bulb Extract, Cannabinoid One (CB1) receptor, IBR-Dormin, Hemp-extract
- Medical subject headings
- Hirsutism, Hair Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Narcissus Tazetta Bulb Extract and Novel Hemp ExtractDrug
Topical nightly application of phytonutraceutical
| Study group | Role | What they receive |
|---|---|---|
| Standard Topical NIghtly Dose | Treatment group Receives: Drug: Narcissus Tazetta Bulb Extract and Novel Hemp Extract |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hair Follicle Number
The change in the number of identifable hair follicles using high-power ProScope
Measured: 60 days
Hair Follicle Diameter
The change in the hair average hair follicle diameter using high-power ProScope
Measured: 60 days
Secondary outcomes (1)
Hair Shaft Color
The change in the darkness of the hair follicles will be measured using high-power ProScope
Measured: 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2023
- Study start1 Sep 2023 (estimated)
- Primary completion1 Dec 2023 (estimated)
- Study completion1 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HirsutismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical Life Care Planners, LLC
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gregory L Smith, MD, MPH, Medical Life Care Planners, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06003062
- Sponsor's protocol ID
- Lip Hair Growth Suppression
- Status last verified
- Aug 2023
- First submitted
- 15 Aug 2023
- Last updated
- 21 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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 21188021Gupta 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 34363728Barrionuevo 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
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Suppression of Upper Lip Hair Growth Using Novel Hemp Extract - A Case Series
- ClinicalTrials.gov ID
- NCT06003062
- Acronym / sponsor ID
- Lip Hair Growth Suppression
- Conditions
- Hirsutism, Hair Diseases
- Keywords
- Narcissus Tarzetta Bulb Extract, Cannabinoid One (CB1) receptor, IBR-Dormin, Hemp-extract
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Medical Life Care Planners, LLCUniversity, hospital or other
- Study start
- 1 Sep 2023 (estimated)
- Primary completion
- 1 Dec 2023 (estimated)
- Study completion
- 1 Dec 2023 (estimated)
- First posted
- 21 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Standard Topical NIghtly Dose | – | Drug: Narcissus Tazetta Bulb Extract and Novel Hemp ExtractTreatment group |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adult women with physician-diagnosed hirsutism presenting to a dermatology clinic.
Key inclusion criteria (1 listed)
- Physician diagnosed upper lip hirsutism Prior use of therapies to treat the upper lip hirsutism No laser, depilation, or waxing within prior 8 weeks -
Key exclusion criteria (2 listed)
- 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
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Narcissus Tazetta Bulb Extract and Novel Hemp ExtractTopical nightly application of phytonutraceutical | Drug | Standard Topical NIghtly Dose |
Primary outcome
Hair Follicle Number
Time frame: 60 days
The change in the number of identifable hair follicles using high-power ProScope
Hair Follicle Diameter
Time frame: 60 days
The change in the hair average hair follicle diameter using high-power ProScope
1 secondary outcome
Hair Shaft Color
Time frame: 60 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2023.
- Background: PubMed 21188021Kopera D, Wehr E, Obermayer-Pietsch B. Endocrinology of hirsutism. Int J Trichology. 2010 Jan;2(1):30-5. doi: 10.4103/0974-7753.66910.
- Background: PubMed 34363728Gupta 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.
- Background: PubMed 29522176Barrionuevo 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Hirsutism and Hair Diseases, run by Medical Life Care Planners, LLC.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gregory L Smith, MD (4044514045, DrSmith@NeX-Therapeutics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hair Follicle Number (time frame: 60 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06003062, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2023.