Trial Outcomes & Findings for Study Evaluating the Effects of Dietary Supplement on Hair Thickness and Hair Strength in Individuals With Self-Perceived Thinning Hair (NCT NCT06605768)
NCT ID: NCT06605768
Last Updated: 2026-02-03
Results Overview
Hair shedding was assessed by trichoscopic evaluation of the target scalp area. The endpoint reflects the proportion of participants meeting the criterion of 1-2 shed hairs per follicular unit at the specified time point.
COMPLETED
NA
80 participants
Day 90
2026-02-03
Participant Flow
Participants were enrolled at a single outpatient research center (ADONIS Plus, Kyiv, Ukraine). Enrollment began on 19 Feb 2024 (first informed consent). Participants attended a site screening visit and, if eligible, were randomized and assigned to supplement or placebo. Study procedures continued through 12 Jul 2024 (last study procedure).
None. After completion of screening assessments, eligible participants were randomized and assigned to supplement or placebo on the same day (no washout or run-in period).
Participant milestones
| Measure |
Group Placebo
Participants received matching placebo capsules containing microcrystalline cellulose (MCC). Dosing: 1 capsule orally twice daily for 90 days (from Visit 2/Day 1 through Visit 6/Day 90).
|
Group Treatment
Participants received the investigational product "Biotin, Collagen \& Keratin Beauty Complex" oral capsules. Dosing: 1 capsule orally twice daily for 90 days (from Visit 2/Day 1 through Visit 6/Day 90).
|
|---|---|---|
|
Overall Study
STARTED
|
40
|
40
|
|
Overall Study
COMPLETED
|
39
|
38
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
Reasons for withdrawal
| Measure |
Group Placebo
Participants received matching placebo capsules containing microcrystalline cellulose (MCC). Dosing: 1 capsule orally twice daily for 90 days (from Visit 2/Day 1 through Visit 6/Day 90).
|
Group Treatment
Participants received the investigational product "Biotin, Collagen \& Keratin Beauty Complex" oral capsules. Dosing: 1 capsule orally twice daily for 90 days (from Visit 2/Day 1 through Visit 6/Day 90).
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Group Placebo
n=37 Participants
Participants received matching placebo capsules containing microcrystalline cellulose (MCC). Dosing: 1 capsule orally twice daily for 90 days (from Visit 2/Day 1 through Visit 6/Day 90).
|
Group Treatment
n=40 Participants
Participants received the investigational product "Biotin, Collagen \& Keratin Beauty Complex" oral capsules. Dosing: 1 capsule orally twice daily for 90 days (from Visit 2/Day 1 through Visit 6/Day 90).
|
Total
n=77 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
21-30
|
13 Participants
n=37 Participants
|
9 Participants
n=40 Participants
|
22 Participants
n=77 Participants
|
|
Age, Customized
31-40
|
10 Participants
n=37 Participants
|
16 Participants
n=40 Participants
|
26 Participants
n=77 Participants
|
|
Age, Customized
41-50
|
14 Participants
n=37 Participants
|
15 Participants
n=40 Participants
|
29 Participants
n=77 Participants
|
|
Sex: Female, Male
Female
|
30 Participants
n=37 Participants
|
37 Participants
n=40 Participants
|
67 Participants
n=77 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=37 Participants
|
3 Participants
n=40 Participants
|
10 Participants
n=77 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Hair Shedding (1-2 hair per unit)
|
27 Participants
n=37 Participants
|
24 Participants
n=40 Participants
|
51 Participants
n=77 Participants
|
|
Hair thinning
|
18 Participants
n=37 Participants
|
20 Participants
n=40 Participants
|
38 Participants
n=77 Participants
|
|
Increase in the amount of vellus hair compared to mature hairs
|
10 Participants
n=37 Participants
|
10 Participants
n=40 Participants
|
20 Participants
n=77 Participants
|
|
Increased distance between units
|
14 Participants
n=37 Participants
|
13 Participants
n=40 Participants
|
27 Participants
n=77 Participants
|
|
Inflammatory processes in the scalp and blood vessels
|
15 Participants
n=37 Participants
|
23 Participants
n=40 Participants
|
38 Participants
n=77 Participants
|
PRIMARY outcome
Timeframe: Day 90Hair shedding was assessed by trichoscopic evaluation of the target scalp area. The endpoint reflects the proportion of participants meeting the criterion of 1-2 shed hairs per follicular unit at the specified time point.
Outcome measures
| Measure |
Group Placebo
n=39 Participants
Participants received matching placebo capsules containing microcrystalline cellulose (MCC). Dosing: 1 capsule orally twice daily for 90 days (from Visit 2/Day 1 through Visit 6/Day 90).
|
Group Treatment
n=38 Participants
Participants received the investigational product "Biotin, Collagen \& Keratin Beauty Complex" oral capsules. Dosing: 1 capsule orally twice daily for 90 days (from Visit 2/Day 1 through Visit 6/Day 90).
|
|---|---|---|
|
Hair Shedding (1-2 Hairs Per Unit)
Shedding not present
|
21 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: 90 DaysHair thinning was evaluated in the target scalp area using standardized trichoscopic assessment. The endpoint reflects the proportion of participants with visible hair shaft thinning/decreased hair caliber at the specified time point.
Outcome measures
| Measure |
Group Placebo
n=39 Participants
Participants received matching placebo capsules containing microcrystalline cellulose (MCC). Dosing: 1 capsule orally twice daily for 90 days (from Visit 2/Day 1 through Visit 6/Day 90).
|
Group Treatment
n=38 Participants
Participants received the investigational product "Biotin, Collagen \& Keratin Beauty Complex" oral capsules. Dosing: 1 capsule orally twice daily for 90 days (from Visit 2/Day 1 through Visit 6/Day 90).
|
|---|---|---|
|
Hair Thinning
|
17 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: 90 DaysThe vellus-to-terminal hair pattern was assessed by trichoscopy in the target scalp area. The endpoint reflects the proportion of participants with an increased proportion of vellus hairs compared with mature (terminal) hairs at the specified time point.
Outcome measures
| Measure |
Group Placebo
n=39 Participants
Participants received matching placebo capsules containing microcrystalline cellulose (MCC). Dosing: 1 capsule orally twice daily for 90 days (from Visit 2/Day 1 through Visit 6/Day 90).
|
Group Treatment
n=38 Participants
Participants received the investigational product "Biotin, Collagen \& Keratin Beauty Complex" oral capsules. Dosing: 1 capsule orally twice daily for 90 days (from Visit 2/Day 1 through Visit 6/Day 90).
|
|---|---|---|
|
Increase in the Amount of Vellus Hair Compared to Mature Hairs
|
14 Participants
|
22 Participants
|
SECONDARY outcome
Timeframe: 90 DaysInter-unit spacing was assessed by trichoscopy in the target scalp area. The endpoint reflects the proportion of participants with an increased distance between follicular units, indicating reduced follicular density, at the specified time point.
Outcome measures
| Measure |
Group Placebo
n=39 Participants
Participants received matching placebo capsules containing microcrystalline cellulose (MCC). Dosing: 1 capsule orally twice daily for 90 days (from Visit 2/Day 1 through Visit 6/Day 90).
|
Group Treatment
n=38 Participants
Participants received the investigational product "Biotin, Collagen \& Keratin Beauty Complex" oral capsules. Dosing: 1 capsule orally twice daily for 90 days (from Visit 2/Day 1 through Visit 6/Day 90).
|
|---|---|---|
|
Increased Distance Between Units
|
12 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: 90 DaysSigns of inflammation were assessed by trichoscopic evaluation of the scalp and superficial vessels in the target area. The endpoint reflects the proportion of participants with trichoscopic signs consistent with inflammatory processes (scalp inflammation and/or vascular changes) at the specified time point.
Outcome measures
| Measure |
Group Placebo
n=39 Participants
Participants received matching placebo capsules containing microcrystalline cellulose (MCC). Dosing: 1 capsule orally twice daily for 90 days (from Visit 2/Day 1 through Visit 6/Day 90).
|
Group Treatment
n=38 Participants
Participants received the investigational product "Biotin, Collagen \& Keratin Beauty Complex" oral capsules. Dosing: 1 capsule orally twice daily for 90 days (from Visit 2/Day 1 through Visit 6/Day 90).
|
|---|---|---|
|
Inflammatory Processes in the Scalp and Blood Vessels
|
20 Participants
|
6 Participants
|
Adverse Events
Group Placebo
Group Treatment
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Group Placebo
n=40 participants at risk
Participants received matching placebo capsules containing microcrystalline cellulose (MCC). Dosing: 1 capsule orally twice daily for 90 days (from Visit 2/Day 1 through Visit 6/Day 90).
|
Group Treatment
n=40 participants at risk
Participants received the investigational product "Biotin, Collagen \& Keratin Beauty Complex" oral capsules. Dosing: 1 capsule orally twice daily for 90 days (from Visit 2/Day 1 through Visit 6/Day 90).
|
|---|---|---|
|
Immune system disorders
Food allergy / allergic reaction
|
2.5%
1/40 • Number of events 1 • "From first dose (Day 1) through end of follow-up (Day 90)."
Adverse events were collected throughout the study period (Day 1-Day 90) via participant reporting and assessment at study visits. Events were recorded by study staff; allergic reactions were monitored due to product ingredients (fish and nuts).
|
2.5%
1/40 • Number of events 1 • "From first dose (Day 1) through end of follow-up (Day 90)."
Adverse events were collected throughout the study period (Day 1-Day 90) via participant reporting and assessment at study visits. Events were recorded by study staff; allergic reactions were monitored due to product ingredients (fish and nuts).
|
Additional Information
Prof. Olga Gyrina
Limited Liability Company Treatment and Diagnostic Center ADONIS Plus, Outpatient Department
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place