CTRI/2022/05/042508已完成未知
An observational, comparative study to understand the difference in scalp physiological parameters in males and females suffering with male pattern baldness and female pattern hair loss.
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 24
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
入选标准
- •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.
排除标准
- •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.
研究者
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