- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07755865
A Clinical Trial to Evaluate the Effects of a Conditioning Mask on Hair Health, Breakage, Hydration, and Detangling
This study evaluates the effects of the Bounce Curl conditioning mask on hair health, breakage, hydration, and detangling. The trial is conducted as a single-arm, unblinded, virtual study in which all 40 enrolled participants use the test product twice per week over a one-week period.
Participants complete self-reported questionnaires at Baseline, after the first use, and at the end of Week 1. The primary objective is to examine the product's effects on hair health as reported by participants, while secondary objectives assess perceived changes in hair quality, hydration, breakage, detangling, softness, and frizz.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
Nevada
-
Las Vegas, Nevada, Förenta staterna, 89101
- Citruslabs
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
Tar emot friska volontärer
Beskrivning
Inclusion Criteria:
- Be male or female.
- Be aged 18-50.
- Must have self-reported curly, coily, or wavy hair.
- In the past four weeks, has been experiencing issues regarding all of the following: hair health, hair breakage, hair hydration, and hair tangling.
- Anyone who washes and styles their hair at least once per week.
- Anyone who has been using the same hair care routine and products for at least one month prior to the study and is willing to maintain this for the study duration, i.e. shampoo and styling products.
- If taking any vitamins, minerals, or herbal supplements that target hair health, has been doing so for at least three months and is willing to maintain this routine for the duration of the study.
- Willing to avoid introducing any new products or any forms of medications or supplements that target hair health and appearance during the study period.
- Willing to avoid any chemical treatments to the hair during the study period, e.g. chemical straightening, hair extensions with chemical bonding, perms, and relaxers.
- Willing to avoid any form of protective styles (braids, singles, corn rows, etc) during the study period.
- Anyone willing to refrain from dying, highlighting, or cutting their hair for the study duration.
- Resides in the United States.
- Anyone who considers themselves in general good health.
Exclusion Criteria:
- Anyone with pre-existing chronic conditions that would prevent participants from adhering to the protocol, including oncological, psychiatric disorders, and history of illness in the last three months.
- Anyone who has gotten a hair chemical treatment (e.g., keratin, dyeing, bleaching, perms) in the last month.
- Is currently undergoing or planning to undergo any significant medical procedures during the study period.
- Currently taking any prescription medication for hair loss.
- Currently has hair in any protective styles such as braids, cornrows, or singles.
- Anyone with any conditions that affect the hair or scalp (e.g., alopecia areata).
- Anyone with any allergies or sensitivities to any of the study product ingredients.
- Any women who are pregnant, breastfeeding, or trying to conceive (or who will be at any point during the study period).
- Anyone unwilling to follow the study protocol.
- Anyone with a history of substance abuse.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Bounce Curl Conditioning Mask
|
All 40 participants receive the Bounce Curl conditioning mask and apply it twice per week over one week.
After shampooing, participants apply a generous amount from ends to roots, leaving it on for 1 minute at the first application and 5 minutes at the second application.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change in Self-Reported Hair Health
Tidsram: Baseline, after first use, and Week 1
|
Mean change in participant-reported hair health assessed via self-reported questionnaire
|
Baseline, after first use, and Week 1
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change in Self-Reported Hair Quality
Tidsram: Baseline, after first use, and Week 1
|
Mean change in participant-reported hair quality assessed via self-reported questionnaire
|
Baseline, after first use, and Week 1
|
|
Change in Self-Reported Hair Breakage
Tidsram: Baseline, after first use, and Week 1
|
Mean change in participant-reported hair breakage assessed via self-reported questionnaire
|
Baseline, after first use, and Week 1
|
|
Change in Self-Reported Hair Hydration
Tidsram: Baseline, after first use, and Week 1
|
Mean change in participant-reported hair hydration assessed via self-reported questionnaire
|
Baseline, after first use, and Week 1
|
|
Change in Self-Reported Hair Detangling
Tidsram: Baseline, after first use, and Week 1
|
Mean change in participant-reported hair detangling assessed via self-reported questionnaire
|
Baseline, after first use, and Week 1
|
|
Change in Self-Reported Hair Softness
Tidsram: Baseline, after first use, and Week 1
|
Mean change in participant-reported hair softness assessed via self-reported questionnaire
|
Baseline, after first use, and Week 1
|
|
Change in Self-Reported Hair Frizz
Tidsram: Baseline, after first use, and Week 1
|
Mean change in participant-reported hair frizz assessed via self-reported questionnaire
|
Baseline, after first use, and Week 1
|
Samarbetspartners och utredare
Sponsor
Samarbetspartners
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- 20779
- legacy-20779
Läkemedels- och apparatinformation, studiedokument
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Studerar en amerikansk FDA-reglerad produktprodukt
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