AN OPEN-LABEL, RANDOMIZED, CLINICAL STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ANAGEN GROW AND ANAGEN GROW IN BOOSTING THE CLINICAL EFFICACY OF MINOXIDIL THERAPY IN SUBJECTS WITH HAIR FALL OF FOLLOWING TYPES: GRADUAL & CONSPICUOUS, DIFFUSED AND FRONTAL THINNING

**Study Title:**An open-label, randomized, clinical study to evaluate the efficacy and safety of Anagen Grow and Anagen Grow in boosting the clinical efficacy of Minoxidil therapy in subjects with hair fall of following types: Gradual & conspicuous, Diffused and Frontal thinning.

Primary Objective:

Ø  To determine the percentage hair fall reduction after 2% Minoxidil usage over 12 weeks period.

Ø  To determine the percentage hair fall reduction after Anagen Grow usage over 12 weeks period.

Ø  To determine the percentage hair fall reduction after usage of combination therapy (2% Minoxidil plus Anagen Grow) over 12 weeks period.

Secondary Objectives:

Ø  To assess the safety and tolerability of Anagen Grow and combination therapy

Ø  To study the overall organoleptic aspects of the above three lines of therapy.

Ø  To access the concordance between the volunteers experience vis-à-vis clinical outcome.

Investigational Medicinal Product (s)

Ø  2% Minoxidil*

Ø  Anagen Grow

Ø  Combination therapy 2% Minoxidil plus Anagen Grow Mintop 2% of Dr. Reddy’s Laboratories, Hyderabad will be used. Anagen Grow is manufactured by Dr. JRK’s Research and Pharmaceuticals Pvt  Ltd.

Study Population:

Thirty healthy adult male and female subjects with symptoms of hair fall as described above.

Inclusion Criteria:

1.     Healthy male or female subjects.

2.     Subjects in the age group 22-40 years (both the ages inclusive).

3.     Subjects willing to give written informed consent and agree to come for regular follow up visits.

4.     Subjects willing to maintain the same hairstyle by abstaining from coloring, experimenting with newer shampoos and other types of hair care products during the study period.

5.     Subjects willing to refrain from perming and straightening during the study period.

6.     Subjects who are willing to avoid usage of oral medications for hair growth during the study period.

7.     Subjects whose laboratory values during screening period are within normal limits or considered normal by the physician or Principal/Clinical Investigator and have no clinical significance.

8. Subjects who have no clinically significant abnormalities on the scalp during physical examination such as Tinea capitis, dandruff, Seborrheic dermatitis, Piedra, head louse and scabies.

9.     Subjects with no clinical abnormalities during physical examination, which may interfere in the trial.

10.  Female subjects with negative urine pregnancy test.

11.  Female subjects willing to avoid conception of pregnancy during study period.

Exclusion Criteria:

 1.       Subjects with known hypersensitivity to minoxidil and allergic skin.

2.       Pregnant or lactating females.

3.       Subjects with history of hypotension (blood pressure less than 90/60 mmHg).

4.       Subjects with untreated or uncontrolled hypertension.

5.       Subjects with chronic dermatological conditions of the scalp (e.g., eczema, psoriasis, infection etc).

6.       Subjects with inflammatory scalp conditions such as lichen planopilaris.

7.       Subjects with current or prior use of oral hair regrowth medications (finasteride, other 5 alpha reductase inhibitors) within one year or the use of nutraceutical/botanical for the above purpose in last three months before enrolment.

8.       Subjects with application of a topical minoxidil preparation, or any other topical over the counter or prescription medication for hair regrowth to the scalp for two weeks or more during the six months before enrolment.

9.       Subjects using medications known to cause hair thinning such as Coumadin and anti-depressants/anti-psychotics.

10.    Subjects with concomitant use of the drugs causing a hair loss (e.g. aromatase inhibitors, cytostatics, etc,)

11.    Subjects with prior hair transplant or hair weaves.

12.    Subjects with serious androgenic alopecia.

13.    Subjects with folliculitis.

14.    Subjects with presence or history of cancer including skin cancer.

15.    Subjects with presence or history of an immunocompromised disease.

16.    Subjects known or suspected of not being able to comply with a trial protocol (e.g. alcoholism, drug dependency, or psychotic state)

17.    Subjects with history of severe cardiac, pulmonary, hepatic, renal, endocrine, neurologic disease or mental illness.

18.    Subjects with any medical condition or use of any medications that, in the opinion of the Principal Investigator, should preclude participation.

19.    Subjects who have participated in a clinical study in the past 30 days or current participation in another clinical study.

StStudy Duration: 12 weeks

Visit Schedule

Ø  Visit 01 (Day -3 to -1): Screening Visit

Ø  Visit 02 (Day 0): Enrolment Visit

Ø  Visit 03 (Day 28 ± 2): Assessment Visit

Ø  Visit 04 (Day 56 ± 3): Assessment Visit

Ø  Visit 05 (Day 84 ± 3): End of Treatment Visit

ScScreening Assessments

Ø  Demographic data

Ø  Medical and surgical history

Ø  Medication history

Ø  General physical examination including scalp examination

Ø  Vital signs (blood pressure, pulse rate and temperature)

Ø  ECG

Ø  Serology tests (HIV, HCV, VDRL, HbsAg)

Ø  Urine analysis

Ø  Urine Pregnancy testing (for female subjects)

Ø  CBC, glucose (random), AST, ALT, urea, creatinine, total cholesterol, albumin

Investigational Medicinal Product Usage

Ø  Group 1 (10 subjects): 2% Minoxidil

Ø  Group 2 (10 subjects): Anagen Grow

Ø  Group 3 (10 subjects): 2% Minoxidil and Anagen Grow

Frequency and its duration

The subjects will be advised to use twice daily the respective product (s) assigned to them over 12 weeks period.

In the case of Group 3 where both Minoxidil and Anagen Grow needs to be used, Anagen Grow needs to be used 15 minutes after Minoxidil usage.

Restrictions

The subjects must abstain from the regular hair care practice that is being followed by them and instead they may use mineral oil every alternative day either before hair wash or 3 hours after the product usage.

A very gentle shampoo with pH 7.5 may be used for hair wash. Coloring of hair, perming etc., must be avoided during the trial phase.

 Efficacy Endpoint (s):

Primary Outcome Measures:

Ø  Hair loss measured using hair comb test [Time points: Baseline, Week 4, 8 and 12]

Note:

Ø  The hairs of all the subjects will be combed 10 times using the pre-assigned comb, covering the entire scalp and the hairs that have gathered in the comb or fallen will be collected in a separate plastic bag.

Ø  The hair strands thus collected will be transported to the laboratory for examining the hair shaft anomaly and presence of hair root.

Ø  If hair root is present, further microscopic examination will be performed to understand whether the hair is in anagen stage or telogen stage.

Ø  Proportion of anagen hair [Time points: Baseline and Week 12]

Change from baseline in proportion of anagen hairs (%) on the scalp after 12 weeks of treatment.

Note:

Ø  Unit trichogram will be done in at least three subjects per group.

Ø  Approximately 10 hairs from different scalp region will be pulled out and the hair root will be examined to determine the proportion of anagen hair.

Secondary Outcome Measures:

Ø  Proportion of subjects achieving ≥ 25% reduction in hair loss from baseline [Time point: Week 12]

Ø  Proportion of subjects achieving ≥ 50% reduction in hair loss from baseline [Time point: Week 12]

Ø  Proportion of subjects achieving ≥ 75% reduction in hair loss from baseline [Time point: Week 12]

Ø  Change from baseline in Quality of Life Index score at Week 12

Subject’s rating of treatment benefit

Subjects will be asked to compare the current hair loss condition with that at baseline using a 7 point scale [Time point: Week 12]

3 = significantly improved;

2 = moderately improved;

1 = slightly improved;

0 = no change;

-1 = slightly worse;

-2 = moderately worse;

-3 = significantly worse

Investigator’s rating of treatment benefit

Investigators will be asked to compare the current hair loss condition of the subject with that at baseline and rate the treatment using a 5 point scale [Time point: Week 12]

4 = Excellent

3 = Very good

2 = Good

1 = Regular

0 = Bad

Safety assessments will include incidence of adverse events, evaluationof local (application-site) tolerability, clinical laboratory parameters, vitalsigns, and physical examination