- ICH GCP
- US-Register für klinische Studien
- Klinische Studie 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.
Studienübersicht
Status
Intervention / Behandlung
Studientyp
Einschreibung (Tatsächlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
-
-
Nevada
-
Las Vegas, Nevada, Vereinigte Staaten, 89101
- Citruslabs
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
Akzeptiert gesunde Freiwillige
Beschreibung
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.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: N / A
- Interventionsmodell: Einzelgruppenzuweisung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: 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.
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Change in Self-Reported Hair Health
Zeitfenster: 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
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Change in Self-Reported Hair Quality
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
|
Mitarbeiter und Ermittler
Sponsor
Mitarbeiter
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Andere Studien-ID-Nummern
- 20779
- legacy-20779
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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