Androgenetic AlopeciaPhase 2NCT02150187
Efficacy of Nutrition Supplement for Treatment of Men With Hair Loss
A Phase 2 study testing HCap Formula in people with Androgenetic Alopecia, run by Family Marketing at 1 site in Israel.
Trial summary
HCap Formula is composed of medicinal plants, vitamins and minerals. The purpose of this study is to evaluate the efficacy of HCap Formula, a nutrition supplement for promoting hair growth in men with tendencies for hair loss. Read more about this study
- Who is it for?
- Ages 18 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Androgenetic Alopecia
- What is being tested?
- HCap Formula
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 33 participants
- Where
- 1 siteIsrael
- Study dates
- May 2014to May 2015
- Phase
- Phase 2
- 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 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy males between 18-40 years of age.
- No abnormality in blood tests analysis
- Present with mild to moderate androgenic alopecia (AGA) graded IIv, IIIv, IV or V according to the Hamilton-Norwood classification
- Willingness to use the same shampoo, refrain from change in hair style, and refrain from hair dyeing during the study.
- Willingness to refrain from any therapy affecting hair during the study
- Willingness to have photographs of the treated area taken.
- Willingness to follow the treatment schedule and post treatment follow-up.
- Willingness not participate on other studies during the study course
Who cannot join
- General
- Having a known allergy to any of the ingredients in the test products;
- Participation in a study of another device or drug within one month prior to enrollment or during the study.
- Hair treatments/ scalp condition
- Undergone hair transplant surgery, scalp reduction surgery
- Having hair weave or tattooing of the alopecic area.
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- Other hair loss disorders, such as alopecia areata, scarring alopecia.
- Suffering from any active dermatological condition in the treated area such as scalp atrophy, which in the opinion of the investigator might interfere with clinical evaluation.
- Medications
- Use of the following medications within the past 6 months:
- Prescription or over-the-counter systemic or topical treatment specific for androgenic alopecia (such as minoxidil, finasteride, dutasteride).
- 5α-reductase inhibitors for prostate conditions (e.g. benign prostate hyperplasia, prostate cancer) and hormone replacement therapy for transgenders
- Medications with anti-androgenic properties (cyproterone, spironolactone, ketoconazole, flutamide, progesterone, and bicalutamide)
- Medications that can potentially cause hypertrichosis (e.g. cyclosporine, diazoxide, phenothiazines, zidovudine, tamoxifen, carpronium chloride),
- Medications that can potentially cause alopecia such as oral glucocorticoids, lithium, phenothiazines, tamoxifen.
- Use of the following medications within the past 3 months:
- Botanicals/nutraceuticals for hair growth
- Steroids - systemic steroids for more than 14 days (e.g. corticosteroids, anabolic steroids) or topical steroids on the area of hair loss.
- Other medical conditions
- Suffering from significant concurrent illness, such as cardiac disorders, diabetes (type I or II), uncontrolled hypertension, symptomatic hypotension, hyper/hypo thyroidism, or pertinent neurological disorders.
- Suffering from serious medical condition that could adversely affect hair loss such as immunosuppression/immune deficiency disorders (including HIV), history of cancer or having/undergoing any form of treatment for active cancer, connective tissue disorder, inflammatory bowel disease
- As per the Investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Efficacy of Hcap Formula Nutrition Supplement for Treatment of Men With Androgenic Alopecia: A Prospective, Randomized, Double-Blind, Placebo-Controlled Clinical Trial
HCap Formula is composed of medicinal plants, vitamins and minerals. The purpose of this study is to evaluate the efficacy of HCap Formula, a nutrition supplement for promoting hair growth in men with tendencies for hair loss.
Read the detailed description
This study consists of a treatment phase (6 months) and a follow-up phase (6 month ). Eligible subjects will be randomly assigned to receive treatment with the study medication or placebo. Subjects will visit the clinic at 3, 6, and 12 months after treatment start for safety and efficacy evaluations.
HCap Formula or placebo tablets will be taken orally every other day during 6 months.
- Conditions
- Androgenetic Alopecia
- Being tested
- HCap Formula, Placebo
- Keywords
- Androgenetic Alopecia, Male, Baldness, hair loss pattern
- Medical subject headings
- Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HCap FormulaDietary supplement
Pill should be taken every other day during the treatment phase.
PlaceboDietary supplement
Similar pills without active ingredients
| Study group | Role | What they receive |
|---|---|---|
| HCap Formula | Experimental | Pill of HCap Formula every other day for 6 month during the treatment phase; Follow up phase: nothing. Receives: Dietary Supplement: HCap Formula |
| Placebo | Placebo comparator | Same as treatment with placebo pills Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Terminal Hair Count at 26 Weeks Compared to Baseline
The primary outcome will be change in the terminal hair count from baseline to 26 Weeks within a 3 cm diameter circle based on macro-photographs of the same area. The treatment group will be compared to the control.
Measured: Baseline, 26 Weeks
Secondary outcomes (1)
Global Assessment of Improvement from Baseline to 26 and 52 weeks Assessed for Vertex and Frontal Views Separately
Assessment of improvement using a 7-point scale: greatly decreased (-3), moderately decreased (-2), slightly decreased (-1), no change (0), slightly increased (1), moderately increased (2), and greatly increased (3). This assessment will be performed by comparing the global photographs obtained at Baseline with those subsequently obtained at baseline, 26, and 52 weeks. This assessment will be carried out separately on the global photography of the vertex and frontal views
Measured: Baseline, 26 weeks, 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2014 (estimated)
- Study startMay 2014
- Primary completionFeb 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Family Marketing
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David J Friedman, MD, Principal investigator, Friedman Skin & Laser CenterLilach Gavish, PhD, Study director, Friedman Skin & Laser Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02150187
- Sponsor's protocol ID
- ProHair01
- Status last verified
- Jul 2017
- First submitted
- 27 May 2014
- Last updated
- 18 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy of Hcap Formula Nutrition Supplement for Treatment of Men With Androgenic Alopecia: A Prospective, Randomized, Double-Blind, Placebo-Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT02150187
- Acronym / sponsor ID
- ProHair01
- Conditions
- Androgenetic Alopecia
- Keywords
- Androgenetic Alopecia, Male, Baldness, hair loss pattern
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Family MarketingIndustry (pharma, biotech, devices)
- Study start
- May 2014
- Primary completion
- Feb 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 29 May 2014 (estimated)
- 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.
HCap Formula is composed of medicinal plants, vitamins and minerals. The purpose of this study is to evaluate the efficacy of HCap Formula, a nutrition supplement for promoting hair growth in men with tendencies for hair loss.
Detailed description
This study consists of a treatment phase (6 months) and a follow-up phase (6 month ). Eligible subjects will be randomly assigned to receive treatment with the study medication or placebo. Subjects will visit the clinic at 3, 6, and 12 months after treatment start for safety and efficacy evaluations.
HCap Formula or placebo tablets will be taken orally every other day during 6 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HCap Formula | Experimental | Dietary Supplement: HCap FormulaPill of HCap Formula every other day for 6 month during the treatment phase; Follow up phase: nothing. |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboSame as treatment with placebo pills |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Healthy males between 18-40 years of age.
- No abnormality in blood tests analysis
- Present with mild to moderate androgenic alopecia (AGA) graded IIv, IIIv, IV or V according to the Hamilton-Norwood classification
- Willingness to use the same shampoo, refrain from change in hair style, and refrain from hair dyeing during the study.
- Willingness to refrain from any therapy affecting hair during the study
Key exclusion criteria (22 listed)
- General
- Having a known allergy to any of the ingredients in the test products;
- Participation in a study of another device or drug within one month prior to enrollment or during the study.
- Hair treatments/ scalp condition
- Undergone hair transplant surgery, scalp reduction surgery
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 |
|---|---|---|
| HCap FormulaPill should be taken every other day during the treatment phase. | Dietary supplement | HCap Formula |
| PlaceboSimilar pills without active ingredients | Dietary supplement | Placebo |
Primary outcome
Changes in Terminal Hair Count at 26 Weeks Compared to Baseline
Time frame: Baseline, 26 Weeks
The primary outcome will be change in the terminal hair count from baseline to 26 Weeks within a 3 cm diameter circle based on macro-photographs of the same area. The treatment group will be compared to the control.
1 secondary outcome
Global Assessment of Improvement from Baseline to 26 and 52 weeks Assessed for Vertex and Frontal Views Separately
Time frame: Baseline, 26 weeks, 52 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 18 Jul 2017.
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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.
David J Friedman, MD principal investigator
Friedman Skin & Laser Center
Lilach Gavish, PhD study director
Friedman Skin & Laser Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing HCap Formula in people with Androgenetic Alopecia, run by Family Marketing at 1 site in Israel.
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 8 inclusion and 22 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 18 Jul 2017. 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 Israel. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Changes in Terminal Hair Count at 26 Weeks Compared to Baseline (time frame: Baseline, 26 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Jul 2017.