Androgenetic AlopeciaPhase 3NCT03753113

Evaluating the Topical Herbal Solution on the Treatment of Male Pattern Hair Loss and Comparison With Minoxidil 5%

A Phase 3 study testing Topical Herbal Solution and Topical Minoxidil 5% in people with Androgenetic Alopecia, run by Farid Masoud at 1 site in Iran.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The purpose of this study is evaluating the efficacy and safety of a topical herbal solution in males for the treatment of Androgenetic alopecia. Read more about this study

Who is it for?: Ages 18 to 50 years, men onlyHealthy volunteers can take part
Conditions the study is for: Androgenetic Alopecia
What is being tested?: Topical Herbal Solution and Topical Minoxidil 5%
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 24 participants
Where: 1 siteIran
Study dates: 28 Nov 2018to 2 Sep 2019
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 50 years
Men only
Healthy volunteers accepted
Adult

Who may be able to join

Men 18 to 50 years old
Written consent
Normal general health status
Men who have a presentation of androgenetic alopecia (Norwood II - V).

Who cannot join

Use of any topical product in the target region interfering with the study product in the last three months
Within the past 6 months receiving of chemotherapy/cytotoxic agents
Clinical diagnosis of alopecia areata or other non-AGA forms of alopecia
Uncontrolled hypertension
Any dermatological disorders in the scalp, such as fungal or bacterial infections, eczema, atopic dermatitis, seborrheic dermatitis, psoriasis, sun damage, skin cancer
Hormonal diseases such as thyroid disorders, diabetes and, ...

Show all 12Show fewer

Smokers
Liver and kidney disease
History of hair transplants
History of surgical correction of hair loss on the scalp
Subject having dyed, bleached hair or, with a permanent wave prior to study start.
No written consent

Trial locations and contacts

1 site in 1 country.

Iran1 site

Department of Dermatology, Sina Hospital
Tabriz, East Azerbaijan Province

Other trials in Iran

About this study

Official title: Evaluating the Efficacy of Topical Herbal Solution on the Treatment of Androgenetic Alopecia and Comparison With Minoxidil 5%: A Double-Blind, Randomized, Clinical Trial Study

The purpose of this study is evaluating the efficacy and safety of a topical herbal solution in males for the treatment of Androgenetic alopecia.

Read the detailed description

This study will be done on male subjects with Androgenetic alopecia(AGA). The patients will be selected by volunteers attending the Dermatology department of Sina Hospital, and eligible individuals will be selected among them. Subjects were randomized to use either Topical Herbal Solution or Topical Minoxidil 5% for 36 weeks.

To our knowledge, this herbal solution for the first time covers all four major causes of AGA, including the 5α-reductase enzyme, androgen receptors, paracrine agents that affecting dermal papilla and hair cell apoptosis processes. Therefore it acts with the quadruple mechanism. The application of this new herbal solution for the treatment of AGA should be recommended.

Conditions: Androgenetic Alopecia
Being tested: Topical Herbal Solution, Topical Minoxidil 5%
Keywords: Androgenic Alopecia, Hair Diseases, Skin Diseases, Baldness, Alopecia, Hair Loss
Medical subject headings: Alopecia, Hair Diseases, Skin Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Topical Herbal SolutionDrug
Use Topical Herbal Solution every day in scalp hair loss areas for 36 weeks.
Topical Minoxidil 5%Drug
Also called Minoxidil
Use Minoxidil 5% solution every day in scalp hair loss areas for 36 weeks.

Study groups in NCT03753113
Study group	Role	What they receive
Treatment group	Experimental	The patients will be applied 1 mL of solutions(Herbal and Minoxidil) at morning and evening intervals to the thinning hair areas of the scalp for 36 weeks. Receives: Drug: Topical Herbal Solution; Drug: Topical Minoxidil 5%
Control group	Active comparator	The patients will be applied 1 mL of Minoxidil 5% solutions at morning and evening intervals to the thinning hair areas of the scalp for 36 weeks. Receives: Drug: Topical Minoxidil 5%

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Hair Diameter
Change in hair diameter over time as compared to Baseline. Hair diameter measured via a digital micrometer.
Measured: baseline, 12, 24, and 36 weeks

Secondary outcomes (2)

Patients Self - Assessment Questionnaire
Self-administered hair growth questionnaire, consisting of 4 questions in the patient's language on treatment efficacy and three questions on satisfaction with appearance. For differences between self-assessment questionnaires. This questionnaire following 5-point scale: 1 = very satisfied, 2 = satisfied, 3 = neutral (neither satisfied nor dissatisfied), 4 = dissatisfied, 5 = very dissatisfied. Higher scores indicated a worse outcome.
Measured: through study completion
Adverse Events
Incidence of adverse events such as itching, redness, inflammation etc
Measured: baseline, 12, 24, and 36 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

28 Nov 20182 Sep 2019

First posted26 Nov 2018
Study start28 Nov 2018
Primary completion2 Sep 2019
Study completion2 Sep 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Androgenetic AlopeciaStudies 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: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 24 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03753113
Sponsor's protocol ID: TabrizUMS
Status last verified: Mar 2020
First submitted: 21 Nov 2018
Last updated: 16 Mar 2020
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Masoud F, Alamdari HA, Asnaashari S, Shokri J, Javadzadeh Y. Efficacy and safety of a novel herbal solution for the treatment of androgenetic alopecia and comparison with 5% minoxidil: A double-blind, randomized controlled trial study. Dermatol Ther. 2020 Nov;33(6):e14467. doi: 10.1111/dth.14467. Epub 2020 Nov 5.
PubMed 33112463

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 2
Phase 2 Efficacy and Safety of PP405 in Adult Females With Androgenetic Alopecia
Androgenetic Alopecia
Not yet recruitingPhase 3
Phase 3 Study to Evaluate the Efficacy and Safety of Oral Minoxidil (N1087) in Men With Androgenetic Alopecia.
Androgenetic Alopecia, Androgenetic Alopecia (AGA)
Not yet recruiting
Study to Evaluate Xtressé Gummy Supplement in Women With Thinning Hair
Androgenetic Alopecia
Not yet recruitingEarly Phase 1
Evaluating the Efficacy of Platelet-rich Plasma Therapy in the Treatment of Androgenic Alopecia
Androgenic Alopecia
Not yet recruitingPhase 3
Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of N1087 in Participants With Female Pattern Hair Loss (MINORA-WOMEN)
Female Pattern Hair Loss, Female Pattern Hair Loss, Androgenic Alopecia

All Androgenetic Alopecia trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluating the Efficacy of Topical Herbal Solution on the Treatment of Androgenetic Alopecia and Comparison With Minoxidil 5%: A Double-Blind, Randomized, Clinical Trial Study
ClinicalTrials.gov ID: NCT03753113
Acronym / sponsor ID: TabrizUMS
Conditions: Androgenetic Alopecia
Keywords: Androgenic Alopecia, Hair Diseases, Skin Diseases, Baldness, Alopecia, Hair Loss
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 24 participants (actual)
Lead sponsor: Farid MasoudUniversity, hospital or other
Study start: 28 Nov 2018 (actual)
Primary completion: 2 Sep 2019 (actual)
Study completion: 2 Sep 2019 (actual)
First posted: 26 Nov 2018 (actual)
Results: Posted 16 Mar 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this study is evaluating the efficacy and safety of a topical herbal solution in males for the treatment of Androgenetic alopecia.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Treatment group	Experimental	Drug: Topical Herbal Solution, Drug: Topical Minoxidil 5%The patients will be applied 1 mL of solutions(Herbal and Minoxidil) at morning and evening intervals to the thinning hair areas of the scalp for 36 weeks.
Control group	Active comparator	Drug: Topical Minoxidil 5%The patients will be applied 1 mL of Minoxidil 5% solutions at morning and evening intervals to the thinning hair areas of the scalp for 36 weeks.

Who may qualify

Ages: 18 to 50 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (4 listed)

Men 18 to 50 years old
Written consent
Normal general health status
Men who have a presentation of androgenetic alopecia (Norwood II - V).

Key exclusion criteria (12 listed)

Use of any topical product in the target region interfering with the study product in the last three months
Within the past 6 months receiving of chemotherapy/cytotoxic agents
Clinical diagnosis of alopecia areata or other non-AGA forms of alopecia
Uncontrolled hypertension
Any dermatological disorders in the scalp, such as fungal or bacterial infections, eczema, atopic dermatitis, seborrheic dermatitis, psoriasis, sun damage, skin cancer

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 Herbal SolutionUse Topical Herbal Solution every day in scalp hair loss areas for 36 weeks.	Drug	Treatment group
Topical Minoxidil 5%Also: MinoxidilUse Minoxidil 5% solution every day in scalp hair loss areas for 36 weeks.	Drug	Control group, Treatment group

Primary outcome

Change in Hair Diameter
Time frame: baseline, 12, 24, and 36 weeks
Change in hair diameter over time as compared to Baseline. Hair diameter measured via a digital micrometer.

2 secondary outcomes

Patients Self - Assessment Questionnaire
Time frame: through study completion
Adverse Events
Time frame: baseline, 12, 24, and 36 weeks

Results and safety

Results posted to the registry on 16 Mar 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Treatment Group	12	12
Control Group	12	12

Primary outcome: Change in Hair Diameter

Time frame: baseline, 12, 24, and 36 weeks. Mean (Standard Deviation). Unit: micrometer

Measure	Treatment Group n = 12	Control Group n = 12
Week 12	57.42 (8.88)	51.58 (7.67)
Week 24	60.92 (7.35)	51.17 (7.82)
Week 36	62.67 (7.19)	50.58 (7.38)

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse event data were collected from the beginning of the study until 9 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Treatment Group	0 of 12 (0%)	1 of 12 (8.3%)	0 of 12
Control Group	0 of 12 (0%)	8 of 12 (66.7%)	0 of 12

Limitations and caveats (from the sponsor): Small numbers of subjects

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 33112463Masoud F, Alamdari HA, Asnaashari S, Shokri J, Javadzadeh Y. Efficacy and safety of a novel herbal solution for the treatment of androgenetic alopecia and comparison with 5% minoxidil: A double-blind, randomized controlled trial study. Dermatol Ther. 2020 Nov;33(6):e14467. doi: 10.1111/dth.14467. Epub 2020 Nov 5.
Individual participant dataSharing planned: No

Related trials for Androgenetic Alopecia

Not yet recruitingPhase 2
Phase 2 Efficacy and Safety of PP405 in Adult Females With Androgenetic Alopecia
Androgenetic Alopecia
Not yet recruitingPhase 3
Phase 3 Study to Evaluate the Efficacy and Safety of Oral Minoxidil (N1087) in Men With Androgenetic Alopecia.
Androgenetic Alopecia, Androgenetic Alopecia (AGA)
Not yet recruiting
Study to Evaluate Xtressé Gummy Supplement in Women With Thinning Hair
Androgenetic Alopecia
Not yet recruitingEarly Phase 1
Evaluating the Efficacy of Platelet-rich Plasma Therapy in the Treatment of Androgenic Alopecia
Androgenic Alopecia
Not yet recruitingPhase 3
Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of N1087 in Participants With Female Pattern Hair Loss (MINORA-WOMEN)
Female Pattern Hair Loss, Female Pattern Hair Loss, Androgenic Alopecia

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.

Farid Masoud, PharmD principal investigator

Pharmacy Faculty

Yousef Javadzadeh, Ph.D study director

Department of Pharmaceutics, Pharmacy Faculty

Hamideh Azimi Alamdari, MD principal investigator

Department of Dermatology, Faculty of Medicine

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Topical Herbal Solution and Topical Minoxidil 5% in people with Androgenetic Alopecia, run by Farid Masoud at 1 site in Iran.

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 4 inclusion and 12 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 16 Mar 2020. 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 Iran. 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 phase mean?

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?

Yes. Results are posted in the registry (first posted 16 Mar 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Change in Hair Diameter (time frame: baseline, 12, 24, and 36 weeks). 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 NCT03753113, which also lists 1 linked publication.

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 16 Mar 2020.