Hair Damage, Hair Health, Hair Strength
Conditions
Brief summary
This study is designed to evaluate the efficacy and safety of Hydrolyzed Keratin Peptide Powder in promoting hair health in adult with mild to moderate hair damage, compared to a placebo control.
Interventions
DIETARY_SUPPLEMENTDAP-HAI-403
Each subject takes two capsules per day for 24 weeks. Each capsule contains DAP-HAI-403 250mg.
DIETARY_SUPPLEMENTPlacebo
Each subject takes two capsules per day for 24 weeks.
Sponsors
Dong-A Pharmaceutical
Global Medical Research Center Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* Male or female, aged 19 to 60 years * Subjects with glossy scores between 1 and 3 points on the visual assessment classification and with a total hair damage score of less than 18 points based on exposure to risk factors * Subjects who will refrain from perms or hair coloring, excluding haircuts, during the clinical study period * Subjects who have agreed to participate in this clinical trial prior to its commencement and have signed the written informed consent form
Exclusion criteria
* Subjects with hair loss conditions such as androgenetic alopecia, alopecia areata, telogen effluvium, or cicatricial alopecia at Visit 1 * Subjects who have taken oral dutasteride or finasteride within 6 months prior to Visit 1 * Subjects who have consumed health functional foods (e.g., biotin) or general foods that may affect the human application study within 2 weeks prior to Visit 1 * Subjects who have applied topical steroid preparations to the scalp for one month prior to Visit 1 * Pregnancy or breastfeeding or planning pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The change of hair elasticity | Change of the week 24 from baseline | Elasticity is measured using a Universal Testing Machine (UTM) at a stretching rate of 2 cm/min, and the mean tensile resistance prior to breakage was recorded. A higher score indicates a better outcome. |
| The change of hair luster | Change of the week 24 from baseline | Hair luster is evaluated using visual grading (5-point scale）, glossymeter （mean value ）, and scanning electron microscopy (SEM、 12-point scale ). Both visual grading and glossymeter indicate better outcomes with higher scores. For SEM, lower scores indicate better outcomes. |
| The change of Self-evaluated satisfaction | Change of the week 24 from baseline | Participants assessed their satisfaction of overall changes from baseline across 7 questions, rating perceived satisfaction on a 10-point scale (1 = not at all, 10 = very much). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The change of Hair diameter | Change of the week 24 from baseline | Hair diameter is evaluated by phototrichogram device (Folliscope 5.0) at 50× magnification. A higher score indicates a better outcome. |
| The change of Hair density | Change of the week 24 from baseline | Hair density is measured using Folliscope 5.0 at 14× magnification. A higher score indicates a better outcome. |
| The change of Hair root volume | Change of the week 24 from baseline | Hair root volume was quantified using I Max-plus image analysis software by measuring the angle (°) between the parting's origin and its highest lateral points-smaller angles after treatment indicated improved root lift and volume. |
| The change of Scalp moisture | Change of the week 24 from baseline | Scalp moisture is measured using the DermaLab Hydration Pin Probe. A higher score indicates a better outcome. |
| The change of Scalp TEWL | Change of the week 24 from baseline | Scalp TEWL is assessed using a Tewameter TM Nano. A lower score indicates better outcomes. |
| The change of Self-improvement evaluation | Week 24 | Participants were asked to complete a self-evaluation questionnaire regarding their overall improvement in the study across 5 questions, rating perceived improvement on a 10-point scale (1 = no improvement, 10 = marked improvement). |
Countries
South Korea
Outcome results
None listed