To check the efficacy of holistic hair treatment in treating hair loss
- Conditions
- Health Condition 1: L649- Androgenic alopecia, unspecified
- Registration Number
- CTRI/2023/08/056656
- Lead Sponsor
- Arete Services Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
A willing participant must fulfill the following criteria to be eligible for participation in the study:
1. Male Patients aged 18 to 45 years with male pattern hair loss (Androgenetic Alopecia) of stage 2-4 as per Norwood scale.
2. Subjects willing to provide written informed consent, indicating that they thoroughly understand the purpose and procedures required for the study and are willing to participate in the study.
3. Patients willing to have a mark in the target area.
4. Patient’s willingness to maintain same hair length.
A willing study participant will be excluded from the study, if any of the following criteria is noted:
1. Clinically relevant abnormal physical findings which could interfere with the aim of the study; in particular, skin damage such as skin abrasion, actinic keratosis or any abnormal findings in the scalp.
2. Clinically significant dandruff
3. Active unstable thyroid disease, including subjects on therapy for either hyperthyroidism or hypothyroidism unless their dose of thyroid medication has been stable for atleast 3 months.
4. Suspicion of malignancy, including prostate cancer.
5. Patients who had hair transplant surgery or hair weaving.
6. Patient who had light or laser treatment on the scalp.
7. History or evidence of hair loss other than Androgenetic Alopecia (e.g. due to auto-immune, endocrine, mechanical or infectious process or secondary to a scalp dermatological disorder).
8. Patients with active seborrheic dermatitis.
9. History of varicocele.
10. Clinically relevant abnormal laboratory values indicative of physical illness.
11. Ascertained or presumptive hypersensitivity to the active formulations or any of the excipients.
12. Patient with significant clinical relevant endocrinal, cerebrovascular, skin, pulmonary, haematological, immunological and cardiovascular disease could lead to safety risk.
13. Concurrent use of systemic corticosteroids, topical corticosteroids in the balding are studied, anabolic steroids, over-the-counter.
14. Use of the drugs with anti-androgenic properties within 6 months of study entry.
15. Patient had major surgery within 2 months prior to study entry, or who have not recovered from prior major surgery.
16. Participation in a drug research study within past 3 months.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary objective is to evaluate & compare the efficacy of the test regime with the test serum along with placebo as per Trichoscan® measurement including growth rate & hair density (hair per cm2 of test area)Timepoint: Baseline (month 0), month 2, month 4, month 6 & month 8
- Secondary Outcome Measures
Name Time Method 1.To evaluate hair density within per cm2 of test area in comparison to baseline, month 2, month 4, month 6 & month 8 using instrumental and dermatological assessments <br/ ><br>2.To evaluate and compare the hair thickness at baseline, month 2, month 4, month 6 and month 8 using Trichoscan® <br/ ><br>3.To evaluate and compare reduction in Hair thinning using Norwood scale and photonumerical scale MSCR. <br/ ><br>4.To assess product tolerance and acceptance in a long- term use for 8 months.Timepoint: Baseline (month 0), month 2, month 4, month 6 & month 8