Remancos Underarm Roll-on Deodorant Report REPORT: Evaluation of an underarm roll-on deodorant for its effect on skin moisture and skin colour. STUDY #: RS RO 1/2019 Project #: MREC/H/47/2014: CR Date: 8 October – 29 October 2019 Sponsor: Clini Plus Product: Product Crm002 Conducted by the PHOTOBIOLOGY LABORATORY, Sefako Makgatho Health Sciences University, South Africa Contact details: Physical Address: Postal Address: Room N310 (3 rd Floor) P O Box 218 Basic Medical Science Building MEDUNSA Ga-Rankuwa, 0204 0204 South Africa Tel: +2712 521 4673 Fax: +2712 521 3992 e-mail: [email protected]
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Remancos Underarm Roll-on Deodorant Report
REPORT: Evaluation of an underarm roll-on deodorant for its effect on skin
moisture and skin colour. STUDY #: RS RO 1/2019
Project #: MREC/H/47/2014: CR Date: 8 October – 29 October 2019
Sponsor: Clini Plus
Product: Product Crm002
Conducted by the PHOTOBIOLOGY LABORATORY, Sefako Makgatho Health Sciences University, South Africa
Contact details:
Physical Address: Postal Address: Room N310 (3rd Floor) P O Box 218
EXECUTIVE SUMMARY The objective of the study was to evaluate an underarm roll-on deodorant for its effect on skin moisture and skin colour on healthy human skin. The study was performed on twenty healthy Negroid women between the ages 18 – 45. The test product was applied in a randomized controlled manner to either right or left underarm twice a day for 4 Weeks. The contralateral side was left untreated. Colour measurements were made with a Minolta Chromameter and Courage and Khazaka Mexameter at baseline, week 1, week 2 and week 3 under the left and right arm. The product were applied twice daily to either left or right underarm. Moisturisation measurements were made with a Courage and Khazaka corneometer. Treated sides were randomized and blinded to the Study Investigators. The study was performed according to standard Good Clinical Practice Guidelines under Protocol MREC/H/47/2014: CR of Sefako Makgatho Health Sciences University.
The assessment method was by Chromameter assessment (Konica Minolta Cr400), Mexameter assessment (Courage and Khazaka) and Corneometer assessment (Courage and Khazaka). Chromameter assessments were performed on the undearm prior to application at Week 0 and the site was marked on a template which was used to locate the same site for readings at Weeks 1, 2 and 3. There was a statistically significant difference in colour measurement after Week 1 (mean ∆L* -1.09, p-value from baseline 0.0099) for treated side when compared to untreated side. Mexameter assessments were performed on the undearm prior to application at Week 0 and the site was marked on a template was were used to locate the same site for readings at Weeks 1, 2 and 3. There was a statistically significant difference in colour measurement after Week 2 (mean ∆M -63.04, p-value from baseline 0.0119) for treated side when compared to untreated side. Corneometer assessments were performed on the undearm prior to application at Week 0 and the site was marked on a template which was used to locate the same site for readings at Weeks 1, 2 and 3. There was a statistically significant difference in moisture content measurement after Week 3 (mean ∆C 4.28, p-value from baseline 0.0014) for treated side when compared to untreated side.
Remancos Underarm Roll-on Deodorant Report
INTRODUCTION The objective of the study was to evaluate an underarm roll-on deodorant for its effect on skin moisture and skin colour. The study was performed on twenty healthy Negroid women. Product was applied twice daily and time of application recorded in a diary. Assessment were performed at Baseline, Week 1, Week 2 and Week 3 with Chromameter, Mexameter and Corneometer. The study was conducted according to internationally recognised Good Clinical Practice Guidelines. Permission to conduct the study was covered under protocol approval for project MREC/H/47/2014: CR of the Research, Ethics and Publications Committee of Sefako Makgatho Health Sciences University.
METHOD 1. Study Panel and test sites Approximately 30 potential panellists were recruited in order to have enough panellists to fit the inclusion and exclusion criteria. Potential panellists attended a study briefing. Panellists who met the study criteria were verbally briefed and given Instructions (Appendix 1), Informed Consent forms (Appendix 2) plus coloured duplicate copies of the latter. They then completed Health Questionnaires (Appendix 3) and Informed Consent forms for study purposes. Twenty healthy Negroid females between the ages of 18 and 45 were chosen and given appointments. Panellist Health Questionnaires and Consent Forms were screened, by the Study Investigator 1, for eligibility and completeness. Queries, omissions or potential problems on the forms were "flagged" for clarification the following day. Cards were prepared with the panellist names on one side and unique study numbers on the other. The cards were retained at the study centre and left out on a table where panellists collected them on arrival, prior to signing the register. Panellists were given specifically-timed appointments for the whole study. Inclusion and exclusion criteria were according to the protocol as follows:
1.1 Inclusion Criteria 1. Healthy females between the ages 18 and 45, inclusive at the time of enrollment. 2. Must be daily users of creams and/or lotions (e.g. daily moisturizer) 3. Must be able to understand and be willing to follow study instructions. 4. Voluntarily provide consent and sign an informed consent document. 5. Agree to suspend the use of all treatment products other than the test product(s) provided
through the course of the study. 6. Must present with dark pigmentation under their arms.
1.2 Exclusion Criteria 1. Pregnant, breast feeding or planning on becoming pregnant during the course of the study. 2. History of sensitivity to cosmetics in general. 3. Use of anti-inflammatories or antihistamines during the course of the study. 4. Conditions apparent at entry or recognized after entry that are likely to invalidate a subject's
consent to participate in the study and/or limit the ability of a subject to regularly attend all visits or to comply with all other protocol requirements such as: diseases, injuries, alcoholism, drug abuse, psychosis, antagonistic personality, poor motivation, infirmity disability, or other problems that may be emotional, intellectual, psychological or social.
5. Dermatological disorders that may affect assessment of product performance.
Remancos Underarm Roll-on Deodorant Report
2. Product Product tested were as follows:
Product Crm002 Underarm Roll-on deodorant The product was provided by the Sponsor.
3. Study Staff Principal Investigator: Prof B. Summers (012) 521 4673 [email protected]
_________________________________ Signature _________________________________ Date Study Coordinator: Marlize Lategan (012) 521 4278 [email protected]
_________________________________ Signature _________________________________ Date Study Investigator 1: Lulu Nkomo (012) 521 4278 [email protected]
_________________________________ Signature _________________________________ Date Study Investigator 2: Patience Sibinda (012) 521 3544 [email protected] _________________________________ Signature _________________________________ Date
4. Assessments 4.1 Chromameter and Mexameter The colour intensity of skin was measured using a Konica Minolta Chromameter Cr400 and Courage and Khazaka Mexameter. Study Investigator 3 took chromameter and mexameter readings in triplicate. Appropriate statistical methods (see data section) were used to determine whether there was any significant change in intensity of colour on the assessment sites. 4.2 Corneometer The moisture content of the skin was measured using a Courage and Khazaka corneometer. Study investigator 3 took corneometer readings in triplicate. Appropriate statistical methods (see data section) were used to determine whether there was any significant change in moisture content on the assessment sites.
RESULTS 1. Panellists Nineteen panellists completed the study, one panelist was discontinued due to medical reasons not related to the product and there were no adverse events.
2. Data 2.1 Chromameter Assessment The raw data for the Corneometer assessment are attached. The differences between baseline and samples were determined by calculating the Delta L* (at time t) = [Sample L*(time t)-Sample L*(time o)] – [Untreated L*(time t)-Untreated a*(time 0)]. The results are summarised in the tables below. Table1: Chromameter L* mean and standard deviation values of the difference for product
There was a statistically significant lightening in skin colour on the treated side compared to untreated side from Week 1. (Student’s t-test p=<0.05). Figure1: Chromameter L* mean and standard deviation values of the difference for product compared to untreated, week 1, week 2, and week 3.
Remancos Underarm Roll-on Deodorant Report
2.2 Mexameter Assessment The raw data for the Mexameter assessment are attached. The differences between baseline and samples were determined by calculating the Delta Melanin (at time t) = [Sample Melanin (time t)-Sample Melanin (time o)] – [Untreated Melanin (time t)-Untreated Melanin (time 0)]. The results are summarised in the tables below. Table2: Mexamameter Melanin mean and standard deviation values of the difference for
There was a statistically significant lightening in skin colour on the treated side compared to untreated side from Week 2. (Student’s t-test p=<0.05). Figure2: Mexamameter Melanin mean and standard deviation values of the difference for
product compared to untreated, week 1, week 2, and week 3.
2.3 Corneometer Assessment The raw data for the Corneometer assessment are attached. The differences between baseline and samples were determined by calculating the Delta Hydration (at time t) = [Sample Hydration (time t)-Sample Hydration (time o)] – [Untreated Hydration (time t)-Untreated Hydration (time 0)]. The results are summarised in the tables below. Table3: Corneomameter Hydration mean and standard deviation values of the difference for
There was a statistically significant moisturizing of the skin on the treated side at Week 3 compared to untreated side. (Student’s t-test p=<0.05).
Remancos Underarm Roll-on Deodorant Report
Figure3: Corneometer Hydration mean and standard deviation values of the difference for product compared to untreated, week 1, week 2, and week 3.
Remancos Underarm Roll-on Deodorant Report
CONCLUSION Chromameter assessment The product showed a statistically significant lightening in colour (mean ∆L* -1.09, p-value from baseline 0.0099) as assessed by ∆L* values at week 1. At week 2 the colour change increased (mean ∆L* -2.87, p-value from baseline <0.0001) and at week 3 (mean ∆L* -4.47, p-value from baseline <0.0001). Mexameter assessment The product showed a statistically significant colour change as assessed by ∆M values at week two (mean ∆M -63.04, p-value from baseline 0.0119) and week 3 (mean ∆M* -122.67, p-value from baseline 0.0001). Corneometer assessments The product showed a statistically significant increase in moisture content at week three (mean ∆C 4.28, p-value from baseline 0.0014). The underarm roll-on deodorant had a lightening effect on the pigmentation under the arms from Week 1 and an increase in moisture content after week 3. The roll-on deodorant product therefore did reduce the dark pigmentation and increase the moisture content under the arms in comparison to untreated and placebo.
1. Informed Consent Form 2. Health Questionnaire 3. Data sheets: Chromameter data
Mexameter data Corneometer data
Remancos Underarm Roll-on Deodorant Report
Appendix 1 RS/RO 1/2019 INFORMED CONSENT
DESCRIPTION OF THE STUDY (Part of Sefako Makgatho Health Sciences University Research
Project MREC/H/147/2014: CR)
You are being asked to participate in a clinical study to evaluate the efficacy of a product to even the tone of the underarm skin. A roll-on deodorant product will be applied twice daily over the 4 Weeks of the study. Your availability and attendance at the specified visits is vital for the success of this study and will determine full payment for participation. YOU MUST ARRIVE AT THE TEST CENTRE ON YOUR APPOINTMENT TIMES.
SUBJECT REQUIREMENTS
You must be present approximately one hour for the clinical visit, wearing clothing that will allow
easy examination. You must not use any products on the tests sites (such as moisturisers, sunscreens, lotions, bath oils). You must not use any appliances (such as washcloths, sponges, loofahs, etc.) on the tests sites. You must avoid wetting the tests sites within 2 hours before an assessment, for the duration of the study.
POSSIBLE RISKS OR DISCOMFORTS
Subject may experience discomfort arising from dryness, itching, a brief burning sensation and/or redness on the test sites during the product application phase of the study. Significant new findings identifying additional risks that become known during the course of this study will be provided to you. Subjects who experience too much redness or dryness on their tests site will be discontinued from any further treatment. If study personnel feel your responses are severe, you will be referred to a Consultant Dermatologist at Sefako Makgatho Health Sciences University for evaluation and treatment. Medical consultation will be arranged for subjects who need to be evaluated by a physician. If you are referred to a Consulting Dermatologist or physician, they will have access to all your records including your identity.
COMPENSATION AND ALTERNATIVES
Your participation is voluntary. You may discontinue participation at any time without prejudice. You will be compensated for your participation. Payment for the study will be R1000.00 for completion of the study. No other payments will be made. Other than the compensation described above, you will not directly benefit from this study. This study is for scientific information. Not participating in this study would be your alternative.
CONFIDENTIALITY OF RECORDS
Any information obtained in connection with this study will be maintained in a confidential manner by the Investigator. Your records and the data generated from this study will be available to the Sponsor, using only your subject identification number and age. The results of this study may be published and may be made available to regulatory agencies. In all cases, your identity will be kept confidential.
SUBJECT CONTACTS
If you have any questions related to the study or your rights as a subject, or if you experience any difficulty during this study, please contact Marlize Lategan or Lulu Nkomo at (012) 521 4278 who will refer the matter to Prof Beverley Summers.
I understand that individuals with some health conditions have a higher risk of developing adverse reactions to the test materials or test procedures. I have provided truthful information about my health status to the Investigator’s staff. I do not have any health problems (e.g. insulin-dependent diabetes) which could increase my risk of having an adverse reaction. To the best of my knowledge, I am not allergic or sensitive to soaps, moisturising lotions, or detergents. I do not have any adult history of skin disease and I am not undergoing treatment for any skin condition. I have not participated in a similar study targeting the volar forearms during the four Weeks prior to the start of this study and currently am not participating in any other study. I am not pregnant or breastfeeding.
AUTHORISATION
I agree to see a consulting physician if the Investigator’s staff feels it is warranted. I hereby authorise Sefako Makgatho Helath Sciences University or its representatives to obtain any information and received copies of all medical records concerning any adverse events that may have resulted from test materials or procedures associated with this study. I authorise study personnel to release my medical records to the Consulting Dermatologist. Furthermore, I understand that certain products in the study are highly proprietary to the Sponsor. Therefore, I agree to respect the confidentially of the study and all information pertaining thereto. After reading and understanding the above information, I voluntarily consent to participate in the study. I have been given complete freedom to ask questions about this study and all of my questions have been answered. I agree to inform the Evaluator of any changes in my Medical History. I hereby voluntarily consent to participate in this study. I have received a copy of this form for my records.
FOR MEDUNSA CAMPUS/DR GEORGE MUKHARI HOSPITAL STAFF ONLY I undertake to obtain permission from my supervisor at work, to be allowed time to participate in this study, either through making up work time lost or through taking leave (which ever is appropriate) Signed………………………………………. Date…………………………………
Appendix 2 RS RO 1-2019 Enrolment Form and Health Questionnaire Panellist # ______________ Surname:____________________________________ First Names_____________________________
Home address:________________________________________________________________________
Work Address or MEDUNSA Dept_________________________________________________________
Home Tel no. _________________________Work Tel/ MEDUNSA Ext.___________________________
Date of birth: __________________ ID No (NB Copy of ID is required)___________________________
Preliminary Statement: This questionnaire must be completed by each individual who wishes to volunteer as a candidate for participation in this clinical study. An individual’s eligibility for participation in the study is conditional upon such individual’s completion of all questions on this form truthfully and to the best of his or her knowledge. Precautions will be taken to maintain the confidentiality of the information submitted by candidates on this form. Access to the information submitted on this form will be limited to the Principal Investigator and the study Sponsor. PLEASE MARK THE APPROPRIATE RESPONSE BELOW 1. Can you to read and understand the ENGLISH
language? ........................................................................................................................................ YES ......................................................................................................................................................... NO
2. Have you read, understood and signed an Informed Consent form which describes the study design,
subject responsibilities, and possible risks and discomforts. ..................................................................................................................................... YES ......................................................................................................................................................... NO
3. Are you between the ages of 18 – 45? YES ................................................................................................................................................. NO 4. Are you African? ………………………… YES ................................................................................................................................................. NO 5. Are you willing to come to the test centre for all scheduled
visits? ............................................................................................................................................... YES ......................................................................................................................................................... NO
6. Do you agree to refrain from using any creams, lotions, moisturisers, foam baths, bath oils or any other
skin products on your underarms for the duration of the study? .............................................................................................................................................. YES ......................................................................................................................................................... NO
7. Are you currently participating in another clinical
study? .............................................................................................................................................. YES ......................................................................................................................................................... NO
8. Have you ever had or currently have any of the following: Mark yes or no for each.
9. Are you allergic to, sensitive to, ever developed a rash to any of the following:
Remancos Underarm Roll-on Deodorant Report
Yes No Deodorants ( ) ( ) ____________________________________ Roll-on deodorant s ( ) ( ) Brand: ____________________________________ Internal medications ( ) ( ) Brand: ____________________________________ Topical medications ( ) ( ) Brand: ____________________________________ Laundry detergents ( ) ( ) Brand: ____________________________________ Cosmetics ( ) ( ) Brand: ____________________________________ Fabric Softeners ( ) ( ) Brand: ____________________________________ Bar Soaps ( ) ( ) Brand: ____________________________________ Moisturisers ( ) ( ) Brand: ____________________________________ 10. Are you in “general” good health? Yes ( ) No ( ) 11. Do you remove your underarm hair? Yes ( ) No ( ) 12. How do you remove your underarm hair? ____________________________________________ 13. How often do you remove your underarm hair? ________________________________________ 14. Are you now or have you ever been under the care of a dermatologist? Yes ( ) No ( ) If yes, please describe conditions, treatment and date of treatment:
Retinoids ( ) ( ) Brand: ____________________________________ 17. Are you pregnant or nursing a child? Yes ( ) No ( ) Please supply details of an emergency contact person: Name: ______________________________________ Phone number: ____________________________ Certification and Release: I, _______________________________________________________________, certify that: 1. I have read and understood all information in this Questionnaire, including the Preliminary Statement
above. 2. I have answered all questions completely, accurately, and to the best of my knowledge. 3. If any of the above information becomes incomplete or inaccurate, I will provide updated information
to the Investigator. If any of the information I provide in connection with this Questionnaire is incomplete or inaccurate: (i) I understand that I may, at the discretion of the Investigator, be prevented from participating or terminated immediately from the Study, (ii) I understand that I may suffer adverse health affects as a result of providing incomplete or inaccurate information, and (iii) I agree to release and hold harmless the Investigator and Sefako Makgatho Health Sciences University, and its employees, officers, directors, agents, assigns, and affiliates, from any liability, personal injury, loss, or claim for damages arising out of or in connection with my failure to provide complete and accurate information. _______________________________________ ___________________________________ Subject’s Signature Date _______________________________________ __________________________________ Witness’s Signature Date
FOR OFFICE USE Does the subject meet all inclusion/exclusion criteria at enrolment? Yes ( ) No ( ) I have verified the above information for this subject _______________________ ( Evaluator) Date____________
Remancos Underarm Roll-on Deodorant Report
Remancos Underarm Roll-on Deodorant Report
Appendix 3
Chromameter
L*
Pan Week 0 Week 1 Week 2 Week 3 Pan Week 0 Week 1 Week 2 Week 3
