- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07809191
Hair Regrowth Following Partial Thickness Removal of SSCIS
2. september 2026 opdateret af: Naomi Lawrence, The Cooper Health System
Hair Regrowth Following Partial Thickness Stages in Mohs Micrographic Surgery of Squamous Cell Carcinoma in Situ: A Prospective Pilot Study
Participants are being approached to participate in this study because they are undergoing surgery for a skin cancer known as squamous cell carcinoma in situ (SCCIS) on the scalp.
Standard surgical techniques may remove deeper structures that contain hair follicles, which can result in permanent hair loss.
This study evaluates whether a modified surgical technique, known as partial thickness excision, can preserve hair growth and improve cosmetic outcomes.
Participation involves minimal risk beyond the standard risks of Mohs surgery.
If patients choose to participate, their surgery will be performed using this technique, and photographs will be taken over time to evaluate hair regrowth and healing.
Studieoversigt
Status
Ikke rekrutterer endnu
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
15
Fase
- Ikke anvendelig
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Beskrivelse
Inclusion Criteria:
- Adults ≥ 18 years old
- Histologically confirmed SCCIS
- Lesions located in the hair-bearing scalp
- Ability to provide informed consent
Exclusion Criteria:
- Invasive, poorly differentiated, or high-risk SCC features (e.g., perineural invasion)
- Recurrent SCC at the same site
- Prior radiation therapy to the scalp
- Scarring alopecia or active inflammatory scalp disease at the treatment site
- Immunosuppression that, in the investigator's judgement, increases oncologic risk
- Use of topical minoxidil, oral minoxidil, finasteride, spironolactone, or other hair-growth promoting agents
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Partial Thickness Excision
Participants will receive excision of their squamous cell carcinoma in situ of the scalp via partial thickness excision (removal of epidermal and superficial dermal tissue) in an effort to preserve hair follicles and hair growth potential.
|
Participants will receive excision of their squamous cell carcinoma in situ of the scalp via partial thickness excision (removal of epidermal and superficial dermal tissue) in an effort to preserve hair follicles and hair growth potential.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Hair Growth measured clinically by hair density percentage compared to baseline photo
Tidsramme: 3 and 6 months post-procedure.
|
To evaluate hair growth following partial thickness excision of SCCIS at 3 and 6 months post-procedure.
|
3 and 6 months post-procedure.
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Clearance of SCCIS measured by Mohs surgeons' interpretation of margins on surgical slides.
Tidsramme: Immediately following the final Mohs stage during the index procedure
|
To assess clinical and histologic clearance of SCCIS treated with partial-thickness excision.
|
Immediately following the final Mohs stage during the index procedure
|
|
Patient Satisfaction measured via patient satisfaction questionnaire
Tidsramme: 3 and 6 months post-procedure
|
To evaluate patient-reported satisfaction with hair density and cosmetic outcome. "Are you satisfied with amount of hair//appearance of skin/result of treatment?" etc. on scale of 1-10. 1 being not satisfied and 10 being very satisfied/. |
3 and 6 months post-procedure
|
|
Complications
Tidsramme: 2 weeks post-procedure, 3 months post-procedure, and 6 months post-procedure
|
To document wound-healing, complications, and the need for additional treatment.
|
2 weeks post-procedure, 3 months post-procedure, and 6 months post-procedure
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Anslået)
1. september 2026
Primær færdiggørelse (Anslået)
17. juli 2027
Studieafslutning (Anslået)
17. juli 2028
Datoer for studieregistrering
Først indsendt
4. august 2026
Først indsendt, der opfyldte QC-kriterier
2. september 2026
Først opslået (Faktiske)
9. september 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
9. september 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
2. september 2026
Sidst verificeret
1. juli 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Neoplasmer
- Patologiske Tilstande, Anatomiske
- Neoplasmer efter histologisk type
- Neoplasmer, kirtel og epitel
- Hudsygdomme
- Karcinom
- Neoplasmer, pladecelle
- Hypotrikose
- Hårsygdomme
- Patologiske tilstande, tegn og symptomer
- Hud- og bindevævssygdomme
- Morfologiske og mikroskopiske fund
- Karcinom, pladecelle
- Alopeci
- Pladeplade intraepiteliale læsioner
Andre undersøgelses-id-numre
- 26-044
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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