A Clinical Study to Assess Safety, Efficacy and In-use Tolerability of Different Dosages of Hair Growth Products in Patients With Mild to Moderate Androgenic Alopecia (Grade I to III).

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age25-45
SponsorNovoBliss Research Pvt Ltd

About this trial

This is a prospective, interventional, exploratory, four-arm - dose response study, comparative, double-blind, randomized, placebo-control, proof of concept, safety, efficacy and in-use tolerability study of three different dosage formulation of test hair growth products and placebo in patients with mild to moderate Androgenic Alopecia (Grade I to III).

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Age: 25 to 45 years and above (both inclusive) at the time of consent.

Sex: Males and non-pregnant/non-lactating females (preferably equal number of males and females).

Females of childbearing potential must have a self-reported negative urine pregnancy.

Patient is in good general health as determined by the Investigator on the basis of medical history.

Disqualifiers

Patient have history of severe hair fall due to any clinically significant problems like anaemia, thyroid problems.

Patient have history of any dermatological condition of the scalp other than hair loss and dandruff.

Patient have history of any prior hair growth procedures (e.g. hair transplant or laser).

Patient who had taken topical treatment of hair loss for at least 4 weeks.

Trial design

Design model

Parallel

Treatments tested in this trial

  • SesZen-Bio Low Dose 1 (350 mg extract)

    Other intervention

    Mode of Usage: Swallow the capsule whole with a full glass of water without chewing, crushing, or opening it. Dosage form: Capsule Frequency: One time daily after meal Rout of administration: Oral

  • SesZen-Bio Low Dose 1 (150 mg liposomal)

    Other intervention

    Mode of Usage: Swallow the capsule whole with a full glass of water without chewing, crushing, or opening it. Dosage form: Capsule Frequency: One time daily after meal Rout of administration: Oral

  • SesZen-Bio High Dose 1 (500 mg extract)

    Other intervention

    Mode of Usage: Swallow the capsule whole with a full glass of water without chewing, crushing, or opening it. Dosage form: Capsule Frequency: One time daily after meal Rout of administration: Oral

  • Placebo

    Other intervention

    Mode of Usage: Swallow the capsule whole with a full glass of water without chewing, crushing, or opening it. Dosage form: Capsule Frequency: One time daily after meal Rout of administration: Oral

Treatment groups

72 Participants
are divided into 4 treatment groups
Group A: SesZen-Bio Low Dose 1 (350 mg extract)Experimental treatment 1 intervention
Group B: SesZen-Bio Low Dose 1 (150 mg liposomal)Experimental treatment 1 intervention
Group C: SesZen-Bio High Dose 1 (500 mg extract)Experimental treatment 1 intervention
Group D: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in hair thickness by using CASLite Nova (instrumental analysis)

To assess the effectiveness of the test products in terms of change in hair thickness

Time frame
Baseline before usage of the test products on Day 01 and after usage of the test products on Day 45, Day 90, Day 135 and on Day 180
2

Change in hair density by using CASLite Nova (instrumental analysis)

To assess the effectiveness of the test products in terms of change in hair density

Time frame
Baseline before usage of the test products on Day 01 and after usage of the test products on Day 45, Day 90, Day 135 and on Day 180
3

Change in hair growth rate by using CASLite Nova (instrumental analysis)

To assess the effectiveness of the test products in terms of change in hair growth rate

Time frame
04 before Day 01, Day 01, Day 87, Day 90, Day 177 and on Day 180

Secondary outcomes

1

Change in keratin measurement from hair by using CASLite Nova (instrumental analysis)

To assess the effectiveness of the test products in terms of change in keratin from Androgenic Alopecia affected targeted area and normal scalp- tattoo area measurement from hair

Time frame
Baseline before usage of the test products on Day 01 and after usage of the test products on Day 45, Day 90, Day 135 and on Day 180
2

Change in hair length

To assess the effectiveness of the test products in terms of change in hair length (AG affected area and standard area) by using CASLite Nova (instrumental analysis) followed by Image pro-analysis (software analysis)

Time frame
Baseline before usage of the test products on Day 01 and after usage of the test products on Day 45, Day 90, Day 135 and on Day 180
3

Change in A:T ratio by hair pluck test

To assess the effectiveness of the test products in terms of change in A:T ratio by dermatologist.

Time frame
Baseline before usage of the test products on Day 01 and after usage of the test products on Day 90 and on Day 180
4

Change hair fall from root test by 60 seconds hair combing test

To assess the effectiveness of the test products in terms of change hair fall by dermatologist.

Time frame
04 before Day 01, Day 01, Day 87, Day 90, Day 177 and on Day 180

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

NovoBliss Research Pvt Ltd

Lead sponsor

Zywie Ventures Privated Ltd

Collaborator

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