Androgenetic AlopeciaPhase 2/3NCT04481412
Topical Cetirizine in Androgenetic Alopecia in Females
A Phase 2/3 study testing Topical cetirizine and Topical minoxidil in people with Androgenetic Alopecia, run by Cairo University at 1 site in Egypt.
Trial summary
Cetirizine is a safe and selective, second-generation histamine H1 receptor antagonist, widely used in daily practice. A study showed that cetirizine causes a significant reduction in both the inflammatory cell infiltrate and PGD2 production. Read more about this study
- Who is it for?
- Ages 20 to 50 years, women only
- Conditions the study is for
- Androgenetic Alopecia
- What is being tested?
- Topical cetirizine and Topical minoxidil
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 1 siteEgypt
- Study dates
- 25 Jul 2020to 30 Nov 2021
- Phase
- Phase 2/3
- 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 20 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Females with androgenetic alopecia of age 20-50 years.
- Patients experiencing active hair loss within the last 12 months.
- Sinclair scale 2, 3 and 4.
- Patients willing to continue their current regimen of vitamins and nutritional supplements and not start any new vitamins or nutritional supplements for the duration of the study.
- Patients willing to use a mild non-medicated shampoo and conditioner for the duration of the study.
- Patients who did not receive topical or systemic treatment for androgenetic alopecia or prostaglandins in the last 6 months.
Who cannot join
- 1. Patients with a chronic dermatological condition (eczema, psoriasis, infection, etc) of the scalp other than FPHL.
- 2. Subjects who had hair transplants, scalp reduction, current hair weave or tattooing in the target area, which makes it difficult to perform hair count assessment.
- 3. Subjects who received radiation therapy to the scalp, or has had chemotherapy in the past year.
- 4. Subjects who have a known underlying medical problem that could influence hair growth such as HIV infection, connective tissue disease, a thyroid condition, inflammatory bowel disease or other medical conditions, at the discretion of the investigator.
- 5. Subjects with clinical diagnosis of alopecia areata or other non-AGA forms of alopecia.
- 6. Pregnant or lactating females or planning to become pregnant for the duration of the study.
Show all 10Show fewer
- 7. Patients with severe cardiovascular disease, uncontrolled or untreated hypertension, arrythmia or clinically relevant hypotension.
- 8. Subjects with hair loss for greater than 5 years, as medical therapy is unlikely to have much effect at restoring hair follicles inactive for that long of a period.
- 9. The subject has known hypersensitivity or previous allergic reaction to any of the active or inactive components of the test articles.
- 10. Patients using any medications that potentially cause drug-induced hair loss (e.g., depotestosterone, haloperidol, methotrexate, methylprednisolone, prednisone, testosterone, divalproex sodium) within the last 3 months.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Al-Kasr Al-Ainy outpatient dermatology clinic
Cairo, ِAl-Kasr Al-Ainy, 11559
About this study
Official title: The Role of Cetirizine in Androgenetic Alopecia in Females
Cetirizine is a safe and selective, second-generation histamine H1 receptor antagonist, widely used in daily practice. A study showed that cetirizine causes a significant reduction in both the inflammatory cell infiltrate and PGD2 production. A pilot study on topical cetirizine showed that cetirizine increased total hair density, terminal hair density and diameter. Also, its lower potential side effects if compared with other drugs commonly used for AGA, as minoxidil, can promote a wider use and better compliance of cetirizine in the future for the treatment of AGA. Combinations of therapies are likely to be more efficacious than single treatments.
Treatments to clinically improve scalp hair density and reduce mid-pattern thinning leading to improved scalp coverage are highly important for the affected women. On the basis of the above evidence and lacking studies that confirm the effectiveness of cetirizine in AGA treatment, the aim of this study is to evaluate the efficacy and tolerability of topical cetirizine in female patients with AGA.
Read the detailed description
Androgenetic alopecia (AGA) is the most common form of alopecia in men and women. It is a hereditary, androgen-dependent, progressive thinning of scalp hair that follows a defined pattern. The disease mechanism is still relatively poorly understood, but involves a strong genetic contribution as well as some environmental input. AGA manifests as a noticeable reduction of scalp hair coverage, shorter miniaturized telogen vellus hair follicles, and significantly slower rates of hair growth. Approximately 6% to 38% of healthy women experience some degree of frontal and frontoparietal hair loss. AGA may have significant impact on quality of life in female patients. When female AGA is associated with high levels of androgens, systemic antiandrogenic therapy may be needed. However, treating it with oral antiandrogens is usually ineffective suggesting that most female AGA cases are not systemic androgen dependent and topical treatment may be more appropriate.
Currently, the only clinically validated and licensed medication approved for increasing hair density in women with AGA is 2 % minoxidil topical solution, and up to 5% minoxidil in several countries. The collective effects of minoxidil lead to increased cutaneous blood flow, prolongation of the anagen growth phase, and increase in the size of smaller hair follicles. However, it produces moderate results, and must continue to be used to have a continued benefit, and may produce adverse side effects. The use of higher concentrations of minoxidil in women is supported by results from an early study suggesting that concentrations higher than 2% could improve efficacy without increasing the rates of adverse events when applying not more than 60 mg of minoxidil per day.
Based on the hypertrichosis observed in patients treated with analogues of prostaglandin F2a (PGF2a) (i.e. latanoprost used for glaucoma), it was supposed that prostaglandins would have an important role in hair growth. Their action is variable depending on the class they belong to: prostaglandin E(PGE) and PGF2a play a generally positive role on the hair growth, while PGD2 has an inhibitory role on the hair growth. Elevated levels of prostaglandin D2 synthase (PGDS) were found at the messenger ribonucleic acid (mRNA) and protein levels in bald scalp versus haired scalp of men with AGA; as well as the enzymatic product of PGDS, (PGD2), is generally elevated in bald human scalp tissue.
Cetirizine is a safe and selective, second-generation histamine H1 receptor antagonist, widely used in daily practice. A study showed that cetirizine causes a significant reduction in both the inflammatory cell infiltrate and PGD2 production. However, these effects apparently are not related to its anti-H1 activity. A pilot study on topical cetirizine showed that cetirizine increased total hair density, terminal hair density and diameter. Also, its lower potential side effects if compared with other drugs commonly used for AGA, as minoxidil (which often cause of hypertrichosis, contact allergic dermatitis, headache and hypotension), can promote a wider use and better compliance of cetirizine in the future for the treatment of AGA. Combinations of therapies are likely to be more efficacious than single treatments.
Treatments to clinically improve scalp hair density and reduce mid-pattern thinning leading to improved scalp coverage are highly important for the affected women. On the basis of the above evidence and lacking studies that confirm the effectiveness of cetirizine in AGA treatment, the aim of this study is to evaluate the efficacy and tolerability of topical cetirizine in female patients with AGA.
- Conditions
- Androgenetic Alopecia
- Being tested
- Topical cetirizine, Placebo, Topical minoxidil
- Keywords
- cetirizine, minoxidil, androgenetic alopecia (AGA), Female pattern hair loss (FPHL)
- Medical subject headings
- Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Topical cetirizineDrug
Also called Cetirizine 1%
Topical cetirizine 1% spray that will be prepared at Faculty of Pharmacy, Cairo University and will be applied once daily.
PlaceboDrug
Also called 96% ethanol
96% ethanol that will be applied once daily.
Topical minoxidilDrug
Also called Minoxidil 5%
Topical Minoxidil 5% that will be applied once daily.
| Study group | Role | What they receive |
|---|---|---|
| Study group | Experimental | (33) patients will apply topical minoxidil (5%) once daily and topical cetirizine (1%) once daily on their scalp for 6 months. Receives: Drug: Topical cetirizine; Drug: Topical minoxidil |
| Control group | Active comparator | (33) patients will apply topical minoxidil (5%) once daily and placebo once daily on their scalp for 6 months. Receives: Drug: Placebo; Drug: Topical minoxidil |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change from baseline in number of terminal hairs and vellus hair
Trichoscopic evaluation: of frontal, occipital and temporal areas regarding the change from baseline in number of terminal hairs, growing hair and vellus hair.
Measured: baseline, 12, 24 weeks
The change from baseline in hair shaft thickness
Trichoscopic evaluation: of frontal, occipital and temporal areas regarding the change from baseline in hair shaft thickness.
Measured: baseline, 12, 24 weeks
The change from baseline in terminal and vellus hair density
Trichoscopic evaluation: of frontal, occipital and temporal areas regarding the change from baseline in number of follicular openings.
Measured: baseline, 12, 24 weeks
The change in patient self-assessment from baseline
Patient self-assessment of hair growth will be determined by means of a set of predetermined 5 questions in Arabic, each of which asks the patient about a specific aspect of their hair compared with the start of the study.
Measured: baseline, 6, 12, 18, 24 weeks
Secondary outcomes (2)
The change in hair growth from baseline using global photographic assessment
Standardized photographs of the scalp will be taken.
- An expert panel of 3 blinded dermatologists will evaluate hair growth or loss from baseline by comparing baseline with follow-up photographs of each subject by means of a 7-point scale to answer the following question: "How would you subjectively rate the patient's hair growth at this time point compared to baseline?". The scale ranges from-3 ( greatly decreased) to +3 (greatly increased). Assessments will be made at the 12th and 24th week by comparing the global photographs taken at baseline with those taken at each visit.
- Investigator assessment: Same as the expert panel assessment.
Measured: baseline, 12, 24 weeks
Number of patients with adverse effects
Reports of adverse effects or local intolerance, if any, will be collected at every visit.
Measured: 6, 12, 18, 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2020
- Study start25 Jul 2020
- Primary completion30 Nov 2021
- Study completion30 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Androgenetic AlopeciaStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Samar Farghali Farid, Cairo University
- Investigators
- Maggie Abbassi, PhD, Study chair, Faculty of Pharmacy, Cairo UniversityHanan Nada, PhD, Study chair, Cairo UniversitySamar Farid, PhD, Principal investigator, Faculty of Pharmacy, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04481412
- Sponsor's protocol ID
- Cetirizine in alopecia
- Status last verified
- Feb 2023
- First submitted
- 15 Jul 2020
- Last updated
- 8 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jaworsky C, Kligman AM, Murphy GF. Characterization of inflammatory infiltrates in male pattern alopecia: implications for pathogenesis. Br J Dermatol. 1992 Sep;127(3):239-46. doi: 10.1111/j.1365-2133.1992.tb00121.x.
PubMed 1390168Guo H, Gao WV, Endo H, McElwee KJ. Experimental and early investigational drugs for androgenetic alopecia. Expert Opin Investig Drugs. 2017 Aug;26(8):917-932. doi: 10.1080/13543784.2017.1353598. Epub 2017 Jul 12.
PubMed 28689433Rossi A, Campo D, Fortuna MC, Garelli V, Pranteda G, De Vita G, Sorriso-Valvo L, Di Nunno D, Carlesimo M. A preliminary study on topical cetirizine in the therapeutic management of androgenetic alopecia. J Dermatolog Treat. 2018 Mar;29(2):149-151. doi: 10.1080/09546634.2017.1341610. Epub 2017 Jun 29.
PubMed 28604133Bassiouny EA, El-Samanoudy SI, Abbassi MM, Nada HR, Farid SF. Comparison between topical cetirizine with minoxidil versus topical placebo with minoxidil in female androgenetic alopecia: a randomized, double-blind, placebo-controlled study. Arch Dermatol Res. 2023 Jul;315(5):1293-1304. doi: 10.1007/s00403-022-02512-2. Epub 2022 Dec 26.
PubMed 36571611
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Cetirizine in Androgenetic Alopecia in Females
- ClinicalTrials.gov ID
- NCT04481412
- Acronym / sponsor ID
- Cetirizine in alopecia
- Conditions
- Androgenetic Alopecia
- Keywords
- cetirizine, minoxidil, androgenetic alopecia (AGA), Female pattern hair loss (FPHL)
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 25 Jul 2020 (actual)
- Primary completion
- 30 Nov 2021 (actual)
- Study completion
- 30 Nov 2021 (actual)
- First posted
- 22 Jul 2020 (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.
Cetirizine is a safe and selective, second-generation histamine H1 receptor antagonist, widely used in daily practice. A study showed that cetirizine causes a significant reduction in both the inflammatory cell infiltrate and PGD2 production. A pilot study on topical cetirizine showed that cetirizine increased total hair density, terminal hair density and diameter. Also, its lower potential side effects if compared with other drugs commonly used for AGA, as minoxidil, can promote a wider use and better compliance of cetirizine in the future for the treatment of AGA. Combinations of therapies are likely to be more efficacious than single treatments.
Treatments to clinically improve scalp hair density and reduce mid-pattern thinning leading to improved scalp coverage are highly important for the affected women. On the basis of the above evidence and lacking studies that confirm the effectiveness of cetirizine in AGA treatment, the aim of this study is to evaluate the efficacy and tolerability of topical cetirizine in female patients with AGA.
Detailed description
Androgenetic alopecia (AGA) is the most common form of alopecia in men and women. It is a hereditary, androgen-dependent, progressive thinning of scalp hair that follows a defined pattern. The disease mechanism is still relatively poorly understood, but involves a strong genetic contribution as well as some environmental input. AGA manifests as a noticeable reduction of scalp hair coverage, shorter miniaturized telogen vellus hair follicles, and significantly slower rates of hair growth. Approximately 6% to 38% of healthy women experience some degree of frontal and frontoparietal hair loss. AGA may have significant impact on quality of life in female patients. When female AGA is associated with high levels of androgens, systemic antiandrogenic therapy may be needed. However, treating it with oral antiandrogens is usually ineffective suggesting that most female AGA cases are not systemic androgen dependent and topical treatment may be more appropriate.
Currently, the only clinically validated and licensed medication approved for increasing hair density in women with AGA is 2 % minoxidil topical solution, and up to 5% minoxidil in several countries. The collective effects of minoxidil lead to increased cutaneous blood flow, prolongation of the anagen growth phase, and increase in the size of smaller hair follicles. However, it produces moderate results, and must continue to be used to have a continued benefit, and may produce adverse side effects. The use of higher concentrations of minoxidil in women is supported by results from an early study suggesting that concentrations higher than 2% could improve efficacy without increasing the rates of adverse events when applying not more than 60 mg of minoxidil per day.
Based on the hypertrichosis observed in patients treated with analogues of prostaglandin F2a (PGF2a) (i.e. latanoprost used for glaucoma), it was supposed that prostaglandins would have an important role in hair growth. Their action is variable depending on the class they belong to: prostaglandin E(PGE) and PGF2a play a generally positive role on the hair growth, while PGD2 has an inhibitory role on the hair growth. Elevated levels of prostaglandin D2 synthase (PGDS) were found at the messenger ribonucleic acid (mRNA) and protein levels in bald scalp versus haired scalp of men with AGA; as well as the enzymatic product of PGDS, (PGD2), is generally elevated in bald human scalp tissue.
Cetirizine is a safe and selective, second-generation histamine H1 receptor antagonist, widely used in daily practice. A study showed that cetirizine causes a significant reduction in both the inflammatory cell infiltrate and PGD2 production. However, these effects apparently are not related to its anti-H1 activity. A pilot study on topical cetirizine showed that cetirizine increased total hair density, terminal hair density and diameter. Also, its lower potential side effects if compared with other drugs commonly used for AGA, as minoxidil (which often cause of hypertrichosis, contact allergic dermatitis, headache and hypotension), can promote a wider use and better compliance of cetirizine in the future for the treatment of AGA. Combinations of therapies are likely to be more efficacious than single treatments.
Treatments to clinically improve scalp hair density and reduce mid-pattern thinning leading to improved scalp coverage are highly important for the affected women. On the basis of the above evidence and lacking studies that confirm the effectiveness of cetirizine in AGA treatment, the aim of this study is to evaluate the efficacy and tolerability of topical cetirizine in female patients with AGA.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Drug: Topical cetirizine, Drug: Topical minoxidil(33) patients will apply topical minoxidil (5%) once daily and topical cetirizine (1%) once daily on their scalp for 6 months. |
| Control group | Active comparator | Drug: Placebo, Drug: Topical minoxidil(33) patients will apply topical minoxidil (5%) once daily and placebo once daily on their scalp for 6 months. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Females with androgenetic alopecia of age 20-50 years.
- Patients experiencing active hair loss within the last 12 months.
- Sinclair scale 2, 3 and 4.
- Patients willing to continue their current regimen of vitamins and nutritional supplements and not start any new vitamins or nutritional supplements for the duration of the study.
- Patients willing to use a mild non-medicated shampoo and conditioner for the duration of the study.
Key exclusion criteria (10 listed)
- 1. Patients with a chronic dermatological condition (eczema, psoriasis, infection, etc) of the scalp other than FPHL.
- 2. Subjects who had hair transplants, scalp reduction, current hair weave or tattooing in the target area, which makes it difficult to perform hair count assessment.
- 3. Subjects who received radiation therapy to the scalp, or has had chemotherapy in the past year.
- 4. Subjects who have a known underlying medical problem that could influence hair growth such as HIV infection, connective tissue disease, a thyroid condition, inflammatory bowel disease or other medical conditions, at the discretion of the investigator.
- 5. Subjects with clinical diagnosis of alopecia areata or other non-AGA forms of alopecia.
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 |
|---|---|---|
| Topical cetirizineAlso: Cetirizine 1%Topical cetirizine 1% spray that will be prepared at Faculty of Pharmacy, Cairo University and will be applied once daily. | Drug | Study group |
| PlaceboAlso: 96% ethanol96% ethanol that will be applied once daily. | Drug | Control group |
| Topical minoxidilAlso: Minoxidil 5%Topical Minoxidil 5% that will be applied once daily. | Drug | Control group, Study group |
Primary outcome
The change from baseline in number of terminal hairs and vellus hair
Time frame: baseline, 12, 24 weeks
Trichoscopic evaluation: of frontal, occipital and temporal areas regarding the change from baseline in number of terminal hairs, growing hair and vellus hair.
The change from baseline in hair shaft thickness
Time frame: baseline, 12, 24 weeks
Trichoscopic evaluation: of frontal, occipital and temporal areas regarding the change from baseline in hair shaft thickness.
The change from baseline in terminal and vellus hair density
Time frame: baseline, 12, 24 weeks
Trichoscopic evaluation: of frontal, occipital and temporal areas regarding the change from baseline in number of follicular openings.
The change in patient self-assessment from baseline
Time frame: baseline, 6, 12, 18, 24 weeks
Patient self-assessment of hair growth will be determined by means of a set of predetermined 5 questions in Arabic, each of which asks the patient about a specific aspect of their hair compared with the start of the study.
2 secondary outcomes
The change in hair growth from baseline using global photographic assessment
Time frame: baseline, 12, 24 weeks
Number of patients with adverse effects
Time frame: 6, 12, 18, 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2023.
- Background: PubMed 1390168Jaworsky C, Kligman AM, Murphy GF. Characterization of inflammatory infiltrates in male pattern alopecia: implications for pathogenesis. Br J Dermatol. 1992 Sep;127(3):239-46. doi: 10.1111/j.1365-2133.1992.tb00121.x.
- Background: PubMed 28689433Guo H, Gao WV, Endo H, McElwee KJ. Experimental and early investigational drugs for androgenetic alopecia. Expert Opin Investig Drugs. 2017 Aug;26(8):917-932. doi: 10.1080/13543784.2017.1353598. Epub 2017 Jul 12.
- Background: PubMed 28604133Rossi A, Campo D, Fortuna MC, Garelli V, Pranteda G, De Vita G, Sorriso-Valvo L, Di Nunno D, Carlesimo M. A preliminary study on topical cetirizine in the therapeutic management of androgenetic alopecia. J Dermatolog Treat. 2018 Mar;29(2):149-151. doi: 10.1080/09546634.2017.1341610. Epub 2017 Jun 29.
- Derived from this study: PubMed 36571611Bassiouny EA, El-Samanoudy SI, Abbassi MM, Nada HR, Farid SF. Comparison between topical cetirizine with minoxidil versus topical placebo with minoxidil in female androgenetic alopecia: a randomized, double-blind, placebo-controlled study. Arch Dermatol Res. 2023 Jul;315(5):1293-1304. doi: 10.1007/s00403-022-02512-2. Epub 2022 Dec 26.
- Individual participant dataSharing planned: No
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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.
Maggie Abbassi, PhD study chair
Faculty of Pharmacy, Cairo University
Hanan Nada, PhD study chair
Cairo University
Samar Farid, PhD principal investigator
Faculty of Pharmacy, Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Topical cetirizine and Topical minoxidil in people with Androgenetic Alopecia, run by Cairo University at 1 site in Egypt.
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 6 inclusion and 10 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: finished, as of the sponsor's last update on 8 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change from baseline in number of terminal hairs and vellus hair (time frame: baseline, 12, 24 weeks). The study lists 4 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 NCT04481412, which also lists 4 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 8 Feb 2023.