Phase
Condition
Alopecia
Hair Loss
Treatment
Botanical extract of standardized biotin
Placebo
Botanical extract of standardised biotin with silica
Clinical Study ID
Ages 20-60 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Age: 20 to 60 years (both inclusive) at the time of consent
Sex: Healthy males and non-pregnant/non-lactating females.
Subject have complaints of hair fall, thin, dry and brittle hair, and dry skin.
Females of childbearing potential must have a reported negative pregnancy test.
Subject are generally in good health.
Subject must have negative Hepatitis B Surface Antigen Test at baseline.
Subject with self-proclaimed nonpathological thin, dry and brittle hair.
Subject is willing to forgo cosmetic procedures 3 months prior to and for theduration of the study.
Subject is able to remain on stable doses of contraceptive or replacement hormonaltherapy, including no therapy, 6 weeks prior to and for the duration of the study.
Subject is able to follow their normal skin care routines and to refrain fromintroducing any new skin care products during the study.
Subject is able to forgo changes in baseline medications and nutritional supplementsduring the study period.
If the subject is of childbearing potential, is practicing and agrees to maintain anestablished method of birth control (IUD, hormonal implant device/injection, regularuse of birth control pills or patch, diaphragm, condoms with spermicide or spongewith spermicidal jelly, cream or foam, partner vasectomy or abstinence). Femaleswill be considered as non-childbearing potential if they are surgically sterile,have been post-menopausal for at least 1 year or have had a tubal ligation.
If currently using hormonal contraception, has been using this form of contraceptionfor at least 6 months and agrees to continue using the same contraception for theduration of the study.
Subjects are willing not to introduce any new soaps, cleansers, laundry detergents,lotions, creams, shampoos etc. for the duration of the study.
Subjects are willing to give written informed consent and are willing to follow thestudy procedure.
Subjects who have used other marketed products for hair thinning in the past.
Subjects who commit not to use medicated/ prescription shampoos/hair care products (containing Minoxidil / Anti-thinning agents) or any other hair growth, treatmentfor thin hair, or hair products other than the test treatments for the entireduration of the study.
Willing to use test treatments throughout the study period.
Exclusion
Exclusion Criteria:
Subjects with a history of hair thinning/hair fall due to any clinically significantself-reported problems/s like anaemia, thyroid problems, etc.
Subject has a history of allergy or sensitivity to the test treatment ingredients.
Subject has a history of any dermatological condition of the scalp other than hairloss and/or dandruff or active dermatological condition that might interfere withthe clinical assessments (e.g. tattoos, eczema, psoriasis, acne, etc.).
Subject has used any systemic therapy with chronic antibiotic therapy, retinoids,and/or oral steroids during the 4 weeks prior to the start or anticipates having touse at any point during the study.
Subject has applied any topical retinoids within 2 weeks of the screening visit oranticipates having to use at any point during the study.
Subject is not willing to avoid unprotected sun or other UV radiation exposureduring the study period.
Subject is currently pregnant/breastfeeding.
Subject has a history of prior use of hair growth treatment within 3 months.
Subject has a history of any prior hair growth procedures (e.g., hair transplant orlaser).
Subject has a history of alcohol or drug addiction.
Subjects who have plans of shaving scalp hair during the study.
Subject has a past or present condition of irritated or visibly inflamed scalp orsevere scalp disease.
Any other condition which could warrant exclusion from the study, as per thedermatologist's/investigator's discretion.
Pregnant or breastfeeding or planning to become pregnant during the study period.
History of chronic illness which may influence the cutaneous state.
Subjects participating in other similar nutraceuticals, food, supplemental ortherapeutic trials or hair/scalp/skin care products within the last four weeks.
Study Design
Study Description
Connect with a study center
NovoBliss Research Pvt Ltd
Gandhinagar, Gujarat 382421
IndiaSite Not Available
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