None listed
Conditions
Interventions
Intervention1: SBA-1001 Oral Hair Supplement: One soft gel capsule each twice daily orally for 120 days.
Control Intervention1: Placebo: One soft gel capsule each twice daily orally for 120 days.
Sponsors
Atlantic Coast Brands
Eligibility
Inclusion criteria
Inclusion criteria: 1 Healthy females, minimum age greater than equal to 20 years and maximum age less than equal to 55 years of age. 2 Females of childbearing potential must agree to use a medically approved method of birth control and have a negative urine pregnancy test result. 3 Self perceived mild to moderate hair thinning as assessed through a questionnaire scoring associated with diet, stress, or hormonal influences. 4 Willing to allow hair shampooing as per study procedure. 5 Willingness to maintain cut of hair over the duration of the study and to maintain all other general hair regimens. 6 Compliance to all study procedures including those required for Trichoscan measurements. 7 Has given voluntary, written, informed consent to participate in the study. 8 Agree to not substantially change diet, medications or exercise routine for the duration of the study. 9 Willing to add the provided oral supplement to their daily routine. 10 Willing to undergo a brief physical exam to include height, weight, blood pressure, pulse, general physical findings and a scalp exam. 11 Females with Fitzpatrick I-IV photo skin types and as per Savin hair loss classification. 12 Willingness to have digital photography of the target area of scalp for hair counts. 13 Willingness to have ten terminal hairs from the target area cut at the base of the scalp for microscopic hair measurements. 14 Willingness to have their hair shampooed with Keranique Scalp Replenishing Shampoo Damage Control over a sink containing a gauze for hair shedding counts. 15 Willingness of subjects who have color treated hair can have the color treatment performed but with no interference in the study procedures such as Modified hair wash test.
Exclusion criteria
Exclusion criteria: 1 Women who are pregnant, breastfeeding, or planning to become pregnant during the course of the trial. 2 Women who have begun hormonal birth control or hormone replacement within 6 months of randomization. 3 Subjects taking vitamin supplements, including multi-vitamins, within 2 weeks of randomization. 4 Subjects having undergone a form of treatment for thinning hair, including prescription drugs such as Minoxidil, Finasteride, or any 5 α-reductase inhibitor or light therapy within 6 months of randomization. 5 Medical history of diagnosed hair loss disorders, such as alopecia areata, scarring alopecia, androgenetic alopecia, and telogen effluvium trichotillomania as determined on initial study assessment by the Investigator. 6 Subjects currently using hair extensions. 7 Subjects with psoriasis or any active dermatological condition of the scalp at randomization that in the opinion of the qualified investigator would interfere with the clinical evaluations. 8 Subjects using or having used, within the last 6 months, any prescription medication known to affect the hair growth cycle. 9 Medical history of thyroid disorders. 10 Unstable medical conditions as determined by qualified investigator, or any self-reported uncontrolled disease, such as diabetes, hypertension. Medical conditions that are under control with or without treatment will be considered on an individual basis by investigators. 11 Females with self-reported active hepatitis, immune deficiency, HIV or Autoimmune disease. 12 Clinically significant abnormal laboratory results at screening. 13 Participation in a clinical research trial within 30 days prior to randomization. 14 Allergy or sensitivity to study supplement ingredients. 15 Individuals who are cognitively impaired and/or who are unable to give informed consent. 16 Any other condition which in the Investigatorâ??s opinion may adversely affect the subjectâ??s ability to complete the study or its measures or which may pose significant risk to the subject. 17 Subjects with any known allergy or sensitivity to any shampoo or conditioner product. 18 Subjects who have experienced a known stressful event within the last 6 months such as Death in family, miscarriage, etc.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1 Change in visible hair density by Macrophotography. 2 Change in hair density,hair diameter, hair growth rate and anagen/telogen ratio by Trichoscan HD Analysis. 3 Change in the number of hair shed by modified wash test.Timepoint: 1 Macrophotography-Baseline, Day30,Day60,Day90,Day120 and Day180. 2 Trichoscan HD Analysis-Baseline,Day120and Day180. 3 Modified wash test-Baseline,Day10,Day20,Day30,Day40,Day50,Day60,Day70,Day80,Day90,Day100,Day110,Day120 and Day130,Day140,Day150,Day160,Day170 and Day180. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1 Global assessment of improvement in hair growth using a 7-point scale. 2 Savin scale by direct visual examination. 3 Subjective evaluation of hair condition according to self-analysis of hair growth by questionnaire. 4 Subject satisfaction of hair condition according to questionnaire.Timepoint: 1 Global assessment-Baseline,Day30,Day60,Day90,Day120 and Day180. 2 Savin scale-Baseline,Day30,Day60,Day90,Day120 and Day180. 3 Subjective evaluation questionnaire-Day30,Day60,Day90,Day120 and Day180. 4 Subject satisfaction questionnaire-Day30,Day60,Day90,Day120 and Day180. | — |
Countries
India
Contacts
Public ContactMr Subramanian Jagadeesan
ClinWorld Private Limited
Outcome results
None listed