A study to observe and understand the difference in scalp condition in males (with pattern baldness) and females (with pattern hair loss) and to compare scalp physiological parameters of these subjects with the scalp of healthy subjects.
- Conditions
- Health Condition 1: L649- Androgenic alopecia, unspecified
- Registration Number
- CTRI/2022/05/042508
- Lead Sponsor
- Marico Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 24
1. Age: 18 to 45 years (both inclusive) at the time of consent.
2. Sex: Healthy male or non-pregnant/non-lactating/pre-menopausal female.
3. Subjects generally in good health.
4. 12 Subjects (males and females) without any pattern baldness / pattern hair loss.
5. Female subjects of childbearing potential must have a negative urine pregnancy test performed on screening visit and Enrollment.
6. Subjects having hair density of >100 and <200 hair per cm2.
7. 6 Female subjects with hairfall condition:
a.Subjects complaining of hair fall and onset of baldness.
b.Subjects falling under Type 2 - Type 3 of hair loss severity grade evaluated as per Ludwig scale.
8. 6 Male subjects with hairfall condition:
a.Subjects complaining of hair fall and damage.
b.Subjects falling under Type 3 - Type 6 of hair loss severity grade evaluated as per Norwood Scale for male pattern hair loss.
9. Subjects who are non-oil users.
10. Subjects willing to give written informed consent and willing to follow study procedure.
11. Subjects must be able to understand and provide written informed consent to participate in the study.
12. Subjects should be willing and able to follow the study protocol to participate in the study.
13. Subjects willing to refrain from using other products on the scalp other than those provided, including other shampoos/conditioners, scalp and hair treatment and oils/ products that has anti-dandruff action during the study period.
14. Subjects completing the conditioning phase.
15. Subjects willing to use test product throughout the study period.
1. Subjects who have undergone hair growth treatment within 3 months before screening into the study.
2. Subjects having any active scalp disease which may interfere in the study.
3. Subjects who have taken chemotherapy for cancer in the 6 months prior to start of the study or have a plan to do treatments during study.
4. Subjects who have history of alcoholism, smoking, crash dieting and/ or psychiatric disorder including trichotillomania.
5. Subjects who have had hair transplant, who have taken pharmaceutical product which cause hirsutism (ex. phenytoin) and finesteride for androgenic alopecia, under medical treatment for hair problems.
6. Subjects having known history or present condition of allergic response/hypersensitivity to any cosmetic ingredients and pharmaceutical products.
7. Subjects on oral medications, undergoing any chemical hair salon treatment-straightening / perming / colour / henna which will compromise the study.
8. Subjects with chronic illness which may influence the cutaneous state.
9. Subjects participating in other similar cosmetic or therapeutic trial within last three months.
10. Subjects with any history of underlying uncontrolled medical illness including diabetes mellitus, hypertension, HIV, hepatitis, severe anemia, serious disorder of heart and respiratory apparatus or any other serious medical illness.
11. Subjects who have not used anti-dandruff, anti-bacterial, anti-fungal products on their scalps for atleast the past 1 month.
12. Female subjects pregnant or lactating or having menstrual and obstetric disorders.
13. Any other condition which could warrant exclusion from the study, as per the Dermatologistâ??s/investigatorâ??s discretion.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1) Assessment Hairfall by Comb Test <br/ ><br>2) Assessment Hair Strength by Hair Pull Test <br/ ><br>3) Assessment of hair thinning using Norwood and Ludwig scale <br/ ><br>4) Assessment of hair growth rate, density, thickness and density of vellus and terminal using Caslite Nova <br/ ><br>5) Assessment of Anagen & Telogen ratio by hair pluck test & microscopic evaluation <br/ ><br>6) Instrumental Evaluation using Sebumeter (for sebum content), Corneometer (for moisture content) and Tewameter (for transepidermal water loss) <br/ ><br>7) Subjective assessment for hair quality using Dermatological questionnaire <br/ ><br>8) Assessment of scalp biological parameters by evaluating the expression of biomarkers of Inflammation <br/ ><br>9) Assessment of Scalp Microbiome (Bacterial as well as fungal profile and abundance) <br/ ><br>10) Scalp & follicle thickness & Blood flow measurements using UltrasoundTimepoint: Day 01, Day 16, Day 18
- Secondary Outcome Measures
Name Time Method oneTimepoint: None