Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05686928
Other study ID # GLI.04.US.SL.017
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date August 17, 2022
Est. completion date November 30, 2022

Study information

Verified date October 2022
Source Galderma R&D
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To evaluate benefits of a Healing Ointment in skin improvement after dermatologic procedures


Description:

This is an open-label, multi-center study to evaluate the safety and efficacy of a Healing Ointment in skin improvement after dermatologic procedures such as Mohs surgery, skin biopsy, excision on the head/neck or body. The study is designed to enroll approximately 20 subjects, in which 10 subjects undergo dermatologic procedure on the head/neck and 10 subjects on the body. Eligible subjects apply the test product twice daily after the procedure, followed by efficacy and tolerability assessments, standard photography, and self-assessment questionnaire at each follow-up visit.


Recruitment information / eligibility

Status Completed
Enrollment 15
Est. completion date November 30, 2022
Est. primary completion date October 31, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 85 Years
Eligibility Inclusion Criteria: - Subject who undergo Mohs surgery, skin biopsy, excision on the head/neck or body - Ability of giving consent for participation in the study - Agreement to adhere to the procedures and requirements of the study and to report to the institute on the day(s) and at the time(s) scheduled for the assessments Exclusion Criteria: - History of allergy or hypersensitivity to cosmetic ingredients - Pregnant, planning pregnancy during the course of the study or breastfeeding - Subject with a history of keloids or hypertrophic scars - Presence of tattoo and/or scar in the treatment area that in the investigator's opinion would interfere with study assessments - Subjects with history of or the presence of any skin condition/disease that might interfere with the diagnosis or evaluation of study parameters (i.e., atopic dermatitis, eczema, psoriasis, seborrheic dermatitis) at the discretion of the investigator - Subjects with inability to comply with all study protocol restrictions and visits

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Cetaphil Healing Ointment
Topical ointment application twice daily

Locations

Country Name City State
United States Derm Texas Dallas Texas
United States Legacy Dermatology Frisco Texas

Sponsors (1)

Lead Sponsor Collaborator
Galderma R&D

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Objective tolerability assessment using clinical grading analog scale Summary of change in tolerability from baseline to day 28, at the surgical area after using the Healing Ointment daily. Lower scores reflect a better outcome. Assessment parameters include erythema, edema (0 = none, 1 = mild, 2 = moderate, 3 = severe), overall wound appearance (0 = excellent, 1 = good, 2 = fair, 3 = poor), and scabbing/crusting (0 = none, 1 = slight, 2 = moderate, 3 = extensive, 4 = almost complete/complete). Immediately post-procedure (on the same day of the procedure), day 7/14, and day 28 from baseline
Primary Subjective tolerability assessment using an analog scale Summary of change in tolerability from baseline to day 28, at the surgical area after using the Healing Ointment daily. Assessment parameters include burning, itching, and pain (0 = none, 1 = mild, 2 = moderate, 3 = severe) Immediately post-procedure (on the same day of the procedure), day 7/14, and day 28 from baseline
Secondary Subject satisfaction using a self-assessment questionnaire Subjects are asked about their satisfaction with the treatment product and overall improvement at the treated area. Scale consists of 5 questions at every follow-up visit and subjects select level of satisfaction for each question from/to strongly agree, agree, neither, disagree, and strongly disagree. Upon study completion, subjects also provide their perception on recommendation, purchase intent, preference, and testimonial. Day 7/14 and day 28
See also
  Status Clinical Trial Phase
Recruiting NCT04081792 - Optimal Antibiotics for Operated Diabetic Foot Infections N/A
Recruiting NCT02685761 - Skin Incisions and Wound Complication Rates for C-sections in Obese Women N/A
Completed NCT01297322 - RESPECT Trial - (Rapid Extravascular Sealing Via PercutanEous Collagen ImplanT) N/A
Not yet recruiting NCT03872544 - Short Term Status of Free Dermal Fat Autografts for Complex Craniofacial Wounds
Completed NCT03193021 - AMBULATE: Cardiva Mid-Bore VVCS vs. Manual Compression for Multiple Femoral Venous Access Sites, 6 - 12F ID N/A
Not yet recruiting NCT06028854 - Blood Characteristics and Abdominal Emergency Surgery
Completed NCT05646121 - Suprasorb® A + Ag in the Treatment of Wounds at Risk of Infection and Infected Wounds
Enrolling by invitation NCT03880188 - Long Term Status of Free Dermal Fat Autografts for Complex Craniofacial Wounds
Recruiting NCT06342479 - Discharge Training for Patients With Intertrochanteric Fracture N/A
Recruiting NCT03561376 - Zinc Oxide Versus Petrolatum Following Skin Surgery Early Phase 1
Recruiting NCT04994145 - A Post-Market Clinical Investigation on Mepilex Border Post-Op
Recruiting NCT04439552 - fMRI and IVCM Cornea Microscopy of CXL in Keratoconus
Completed NCT05618912 - Scar Appearance After Postoperative Hydrocolloid Dressing Versus Standard Petrolatum Ointment N/A
Completed NCT04596163 - Transversus Thoracis Muscle Plane Block for Sternotomy Pain in Cardiac Surgery N/A
Completed NCT04036344 - Buddy Relationships in DermatoloGic Excisions for Skin Cancer N/A
Completed NCT05791721 - Effect of Preemptive Etoricoxib and Dexamethasone on Wound Healing and Clinical Parameters After Third Molar Surgery Phase 4
Recruiting NCT06073678 - Photobiomodulation in Palate Wounds: Somatosensorial Evaluation N/A
Completed NCT05252260 - Comparison of Diode Laser-Assisted Vestibuloplasty And Conventional Vestibuloplasty N/A
Withdrawn NCT04053946 - Clinical Assessment of Next Science Wound Gels in Healing Below the Knee Amputation Surgical Wound Compared to SOC N/A
Recruiting NCT04740775 - LiquiBand® Exceed™ and LiquiBand® Rapid™ for General Surgery Procedures N/A