None listed
Conditions
Interventions
Intervention1: Anaboom Stem Serum: The Product is applied on Whole Head including Scalp and Hair shaft three times in a week for the period of 28 days.Along with the test product neutral shampoo is us
Sponsors
Sun Pharmaceutical Industries Ltd.
Eligibility
Inclusion criteria
Inclusion criteria: 1)Asian Indian male and female subjects. 2)Healthy subjects (no infectious and evolutive pathology which could make the subject vulnerable and stop the study, no pathology which could interfere with the study, no symptom in the process of an exploratory checkup) 3)Between 18 and 45 years of age. 4)Skin is healthy on the studied anatomic unit (free of eczema, wounds, inflammatory scar….) 5)Specific criteria: Having mild to moderate hair fall.
Exclusion criteria
Exclusion criteria: 1)For female: Being pregnant or breastfeeding or having stopped to breastfeed in the past six months. 2)Having refused to give her assent by not signing the consent form. 3)Taking part in another study is liable to interfere with this study. 4)Having a chronic dermatosis liable to modify the cutaneous reactivity on the tested area. 5)Being insulin-dependent diabetic or non-insulin-dependent diabetic with a recent therapy (less than 6 months) 6)Having a progressive asthma (either under treatment or last fit in the last 2 years) 7)Being epileptic 8)Having non stabilized thyroid problems (requirement of a stabilized treatment for at least 6 months) 9)Having cutaneous hypersensitivity 10)Having a diagnosed or highly probable allergy to one or several compounds of the cosmetic products 11)Following a chronic or intermittent medicinal treatment comprising any of the following products: aspirin-based products, anti-inflammatories, anti-histamines, anti-coagulants, corticotherapy, taken by general or local routes (the only medication permitted is paracetamol) 12)Having undergone a surgery requiring a general anaesthetic of more than one hour in the past 6 months 13)Having changed his/her cosmetic habits except those required by the protocol in the 14 days preceding the start of the study on the studied anatomic unit. 14)Having applied a hair care product and cosmetic product on the studied area as well as on the face the first day of the study (except the neutral shampoo without anti-dandruff and anti hairfall claim) 15)Refusing to follow the below restrictions during the study: For females: Do not take part in any family planning activities leading to pregnancy and breastfeeding. Do not take part in another study liable to interfere with this study. Do not take medicinal treatment comprising any of the following products: aspirin-based products, anti-inflammatories, anti-histamines, anti-coagulants, corticotherapy, taken by general or local routes (the only medication permitted is paracetamol) Do not change his/her cosmetic habits apart from the particular conditions mentioned in the protocol, on the studied anatomic unit. During the study: Do not use other hair care products than the tested products to the studied areas (except the neutral shampoo without anti-dandruff and anti hairfall claim.) The day of the measurements: No hair care must be used including test product. Having untangled their hair at home, before coming to the site for observations, the first day of the study. 16)Specific criteria Having naturally fair or white hair (Which will interfere the evaluation) Having a dermatosis on the scalp Having surgery history on the scalp (micro transplants …) Refusing the bleaching of two areas of the scalp of approx. 40 hairs, the first day of the study. Refusing the plucking of approx. 10 hairs, during the entire study Having presented a factor inducing a telogen effluvium in the 3 months preceding the start of the study (delivery, important stress, high fever…) In the previous 6 months Having undergone the Minoxidil treatments Antiandrogen medicine (cyproterone acetate, spironolactone, flutamide) Having undergone one of the following treatments known to induce hair loss: retinoids, anti-coagulants, anti-convulsive drugs,
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction in number of fallen hairTimepoint: Baseline, Day 28 | — |
Secondary
| Measure | Time frame |
|---|---|
| Reduction in the number of fallen hairs, Improvement in hair length, Safety evaluation based on dermatologist assessment, Percentage of subjects reporting improvement in: Reduction of hair fall, Improvement in hair growth, Subject Self-Evaluation questionnaire scores for Safety & Cosmetic appeal.Timepoint: Baseline, Day 14, Day 28 | — |
Countries
India
Contacts
Public ContactDr Mohit Lalvani
MASCOT-SPINCONTROL India Pvt. Ltd.
Outcome results
None listed