Repeat Insult Patch Test of Skin Irritation/Sensitization NCT01887808

Updated 06/21/2024

Clinical Trial Details — Status: Completed

Administrative data
NCT number	NCT01887808
Other study ID #	GLI.04.SRE.US10232b
Secondary ID
Status	Completed
Phase	N/A
First received
Last updated
Start date	December 2012

Study information
Verified date	June 2013
Source	Galderma R&D
Contact	n/a
Is FDA regulated	No
Health authority
Study type	Interventional

Clinical Trial Summary

Determine if Cetaphil DermaControl Oil Control Moisturizer SPF 30 proves to be a contact sensitizer or irritant in certain individuals

Recruitment information / eligibility
Status	Completed
Enrollment	100
Est. completion date
Est. primary completion date	January 2013
Accepts healthy volunteers	Accepts Healthy Volunteers
Gender	All
Age group	18 Years and older
Eligibility	Inclusion Criteria: - Not currently under a doctor's care - Free of dermatological or systemic disorder which would interfere with the results - Free of any acute or chronic disease - Will complete a preliminary medical history form and are in general good health - Can read, understand, and sign informed consent Exclusion Criteria: - Under 18 years old - Currently under doctor's care - Currently taking any medication - History of acute or chronic disease - Diagnosed with chronic skin allergies - Pregnant or lactating

Study Design

Related Conditions & MeSH terms

Skin Irritation

Intervention

Other:
• Cetaphil DermaControl Oil Control Moisturizer SPF 30

Locations
Country	Name	City	State
n/a

Sponsors *(1)*
Lead Sponsor	Collaborator
Galderma R&D

Outcome
Type	Measure	Description	Time frame	Safety issue
Primary	area of erythema and edema to test reaction of skin to product	9 consecutive 24hr exposures for every Monday, Wednesday, and Friday for 3 consecutive weeks will be conducted to test the reaction of the skin to the test product	3 consecutive weeks

See also
	Status	Clinical Trial	Phase
	Completed	`NCT01806831` - Efficacy and Safety of Biocellulose Sheet Containing Anti-hyperpigmentation Agent ("Biocellulose Mask", "Farhorm®") in Patients Receiving Laser Treatment	N/A
	Completed	`NCT02297841` - Repeated Insult Patch Test of Personal Lubricants	N/A
	Completed	`NCT02968446` - Effect of Vitamin D After Application With Valchlor	Early Phase 1
	Completed	`NCT03397862` - A Skin Irritation Assessment of Once-Weekly Corplex™ Donepezil Transdermal Delivery System	Phase 1
	Unknown status	`NCT01821274` - A 21-Day Topical Safety Study of Diltiazem Hydrochloride Using a Cumulative Irritant Patch Test Design	Phase 1
	Completed	`NCT01892657` - Cetaphil® Daily Facial Moisturizer With Sunscreen SPF 50+ - Human Repeat Insult Patch Test	Phase 4
	Withdrawn	`NCT02400320` - Local Skin Safety Study of a Topical Pain Relief Spray Containing a Combination of Diclofenac, Methyl Salicylate, and Menthol	Phase 4
	Not yet recruiting	`NCT02645110` - Evaluation of Effectiveness and Mildness of Whole-natural Hand-wash Formulations	N/A
	Completed	`NCT01892410` - Patch Test Skin Irritation/Sensitization of Cetaphil Restoraderm Skin Restoring Body Wash	N/A
	Completed	`NCT01887860` - Patch Test Skin Irritation/Sensitization of Cetaphil Daily Facial Moisturizer SPF 50	N/A
	Completed	`NCT01888887` - Repeat Insult Patch Test of Skin Irritation/Sensitization for Cetaphil Daily Facial Cleanser	N/A
	Completed	`NCT01892423` - Repeat Insult Patch Test for Daily Advance Cetaphil Moisturizing Lotion	N/A