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You are cordially invited to participate in the NovaHope Clinical Trial outlined here.
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The clinical trial, being sponsored by a North American corporation,
offers an opportunity to participate in drug development
with a decent financial grant to investigators participating in the trial.
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Apodictic Research is managing the NovaHope Clinical Trial.
Apodictic has been providing contract clinical research services since 1993,
facilitating and organizing clinical trials for generating credible, world-class data for drug development.
Our clients include various US, Europe, Japan, Australia and India-based blue chip as well as emerging pharmaceutical companies and contract research organizations, including MSD, GSK, Amgen, Cepheid, Astellas, Eisai, TB Alliance, Abbott, Boston Scientific, Takeda & Hoya.
Apodictic uses well-established and documented operational policies & systems to ensure that the processes comply with applicable regulations as well as the global ICH-GCP guidelines.
Clinical Trial Protocol Synopsis
A Phase III, Parallel Design, Triple-Blind, Randomized, Multicenter Clinical Trial to Evaluate Safety & Efficacy of a Topical Treatment in
Male Patients with Androgenic Alopecia
Trial Objectives
Primary Objective
To confirm the superiority of efficacy of Investigational Product (IP) over Active Pharmaceutical Ingredient 1 (API 1) in increasing non-vellus hair count in the target area, following 180 days of treatment in men with Androgenic Alopecia (AGA).
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Secondary Objectives
1. To confirm the superiority of efficacy of IP over API 1 in increasing hair thickness in the target area, following 180 days of treatment in men with AGA.
2. To determine the safety and tolerability of IP.
3. To determine the improvement in functional, emotional and symptom-related Quality of Life following 180 days of treatment in men with AGA.
Investigational Product
Topical treatment: Fixed dose combination of three re-purposed drugs, twice daily application,
for 180 days
Participant Enrollment Criteria
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Men with mild to moderate AGA (Hamilton-Norwood Scale II-IV) and 18 to 41 years of age.
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Body Mass Index (BMI) in the range of 19 to 35 kg/m2.
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No history of AGA treatment in the last 90 days.
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Willing and able to provide written informed consent for participation in the trial and to comply with all trial requirements.
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Availability of and usage familiarity with a personal mobile phone (Android or iOS) with internet connectivity.
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Willing to comply with the following conditions anytime during the study:
6.1 Non-permissible:
6.1.1 Any systemic or topical treatment of any system of medicine (other than trial treatment) for AGA
6.1.2 Hair dyes, hair texturizers, relaxers etc.
6.1.3 Any new vitamins or nutritional supplements that are currently not being administered
6.1.4 Tattooing in the trial target area
6.1.5 Blood donations
6.1.6 OTC hair restorers
6.1.7 Conception by the sexual partner for the period of trial participation
6.1.8 Participation in any other drug or device trials during the course of this trial
Note: However, the following shall be permissible:
i. Non-medicated & anti-dandruff shampoos, scalp/hair applications including styling gels, sprays, mousse (styling gels, sprays, mousse etc. not to be used on trial-visit days).
ii. Current regimen (if any) of vitamins and nutritional supplements​.
Inclusion Criteria
Exclusion Criteria
1. History of scalp treatment including though not limited to any of the following:
1.1 Hair transplant or extension surgery
1.2 Hair weaving
1.3 Laser or light therapy on the scalp
1.4 Micro-needling or intradermal therapy (mesotherapy) on the scalp
1.5 Any other surgical treatment for hair loss
2. Any of the following hair styles:
2.1 Shaved scalp
2.2 Use of occlusive wig, hair extensions, non-breathable wigs
3. History or likelihood of use of any of the protocol specified medicines.
4. History or clinical diagnosis of any of the protocol specified medical conditions.
5. Any other significant abnormalities indicating of severe, acute or chronic medical condition(s) that may lead to hair loss or otherwise interfere with the interpretation of trial results.
6. Any other condition that in the opinion of the investigator makes the patient unsuitable for inclusion in the trial.
7. Known or presumed hypersensitivity to any trial treatment medication; history of anaphylaxis to drugs or allergic reactions in general, which in the opinion of investigator may affect the outcome of trial.
8. Clinically relevant abnormal laboratory values, based on any available laboratory report from the last 30 days.
9. Participation in any investigational or marketed drug or device trial within 90 days prior to screening for this trial.
Trial Visits & Duration
Expected sequence of trial visits and duration of trial participants' participation:
Visit
0
Informed Consent & Screening
Visit 0 & 1 may be on the same day
Visit
1
Enrollment/Recruitment
Run-in period: 20 days
Visit
2
Randomization & Treatment Initiation
Treatment period: 120 days
Visit
3
Interim Assessment
Treatment period: 60 days
Visit
4
End of Treatment Assessment
30 days
Visit
5
Safety Follow-up & Exit
Total Participation of Trial Participants
231 Days (~8 months)
Trial Endpoints
Primary Efficacy Endpoint
Increase in non-vellus hair count in the target area as measured by trichoscopy.
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Secondary Efficacy Endpoints
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Increase in hair thickness in the target area as measured by trichoscopy.
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Improvement in androgenic alopecia affected Quality of Life (QoL) and sensory perceptions as measured by a trial specific QoL & Sensory Assessment Questionnaire.
Safety Endpoint
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Incidence of treatment emerging adverse events.
All trial processes would be performed in compliance with applicable regulations.
Apodictic will provide support for obtaining approvals and for compliance.