CTRI/2025/07/090485
Not yet recruiting
Not Applicable
An open label, single-arm, clinical study to evaluate the efficacy and safety of a test regime in lactating female with hair fall.
ANVEYA LIVING PRIVATE LIMITED1 site in 1 country50 target enrollmentStarted: July 28, 2025Last updated:
Overview
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Clinical assessment of hair fall and Instrumental assessment of Hair thickness and Hair growth rate
Overview
Brief Summary
This is an open label, non-randomized, single-arm, clinical study to evaluate the efficacy and safety of a test regime (Topical Serum + Women’s Post-partum Hair growth Supplement) in lactating female with hair fall.
The potential participants will be screened as per the inclusion and exclusion criteria only after obtaining written informed consent from the participants.
All eligible participants will undergo instrumental assessments, dermatological assessments, laboratory assessments (blood tests) and subjective assessment. Safety will be assessed throughout the study by monitoring adverse events and changes in vital signs (Body temperature, Pulse rate and Blood pressure).
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Masking
- None
Eligibility Criteria
- Ages
- 20.00 Year(s) to 40.00 Year(s) (—)
- Sex
- Female
Inclusion Criteria
- •Healthy lactating female subjects with age between 20 and 40 years (both inclusive at the time of consent).
- •Participants complaining about having at least 50 to 100 hair fall per day.
- •Participants with 50 counts of hair fall from hair combing method (60-sec hair count).
- •Participants having good general health as determined by the Investigator on the basis of medical history and vital signs.
- •Participants of childbearing potential must have a negative urine pregnancy test performed at screening visit.
Exclusion Criteria
- •Participants with clinical diagnosis of hair loss disorder such as alopecia areata or scarring forms of alopecia.
- •Participants with hair loss due to Autoimmune disorder/ Chemotherapy/ immunosuppressive drugs.
- •Participants with history of surgical correction of hair loss on the scalp.
- •Participants with history of any dermatological condition (like psoriasis or infections) of the scalp other than hair loss OR with any active scalp disease which may interfere in the study.
- •Participants with current hair loss or skin disease (e.g., psoriasis, atopic dermatitis, skin cancer, sun damage, seborrheic dermatitis), infections, cuts, and/or abrasions on the scalp or condition (e.g., sunburn, tattoo) on the treatment area, that in the opinion of the investigator, might put the participant at risk or interfere with the study conduct or evaluations.
- •Participants with a history of chronic health conditions (eg, diabetes, hypertension, chronic renal failure, heart and liver disease), endocrine abnormalities including stable thyroid disease, psychiatric illness, bariatric surgery/eating disorders such as bulimia or binge eating, cardiovascular surgery, or history of any other major surgery.
- •Participants with the history of malignancy OR known history of autoimmune thyroid disease, any other thyroid disorder/abnormality or other autoimmune disorders.
- •Participants with known allergy or sensitivity to cosmetic products and/or any ingredients of the test product.
- •Participants who had undergone chemotherapy or radiation within the last 2 years.
- •Participants who have started using hormones for birth control or hormone replacement therapy within the last 6 months.
Outcomes
Primary Outcomes
Clinical assessment of hair fall and Instrumental assessment of Hair thickness and Hair growth rate
Time Frame: Day 00, Day 45 and Day 90
Secondary Outcomes
- Clinical assessment of anagen and telogen ratio (A:T ratio), hair strength, hair and scalp related parameters(Day 00, Day 45 and Day 90)
- Instrumental assessment of hair density and Vellus & terminal hair count.(Day 00, Day 45 and Day 90)
- Laboratory assessments of hormonal and nutritional blood markers(Day 00 and Day 90)
- Participant Evaluation Questionnaire(Day 45 and Day 90)
Investigators
Dr Bhagirath Patel
Cliantha Research
Study Sites (1)
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