Hair Regrowth Following Partial Thickness Removal of SSCIS
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe Cooper Health System
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults ≥ 18 years old
Histologically confirmed SCCIS
Lesions located in the hair-bearing scalp
Ability to provide informed consent
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Partial Thickness Excision
Procedure/SurgeryParticipants 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.
Treatment groups
15 Participants
are divided into 1 treatment groupGroup A: Partial Thickness ExcisionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Hair Growth measured clinically by hair density percentage compared to baseline photo
To evaluate hair growth following partial thickness excision of SCCIS at 3 and 6 months post-procedure.
Time frame
3 and 6 months post-procedure.Secondary outcomes
1
Clearance of SCCIS measured by Mohs surgeons' interpretation of margins on surgical slides.
To assess clinical and histologic clearance of SCCIS treated with partial-thickness excision.
Time frame
Immediately following the final Mohs stage during the index procedure2
Patient Satisfaction measured via patient satisfaction questionnaire
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/.
Time frame
3 and 6 months post-procedure3
Complications
To document wound-healing, complications, and the need for additional treatment.
Time frame
2 weeks post-procedure, 3 months post-procedure, and 6 months post-procedureLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: