Efficacy and safety of sun block in the management of acne and post acne pigmentation among Malaysian patients
| ISRCTN | ISRCTN31328643 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN31328643 |
| Secondary identifying numbers | JKEUPM-2021-288 (NMRR-21-793-59045) |
- Submission date
- 07/10/2022
- Registration date
- 26/10/2022
- Last edited
- 06/08/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Skin and Connective Tissue Diseases
Plain English summary of protocol
Background and study aims:
Acne affects up to 85% of the adolescents, with 80% of cases may develop post acne pigmentation. Retinoids are effective, but intolerance is common, thus limiting their usage. Cosmeceuticals may improve tolerability of retinoids. We aim to explore the effectiveness and tolerability of a Lichochalcone A containing sunscreen in the management of acne and post acne pigmentation.
Who can participate:
Adults, male and female, with mild to moderate acne vulgaris, complicating with post acne pigmentation are eligible to participate
What does this study involve?
This is a randomized, double blinded, comparator-controlled trial will be conducting in the Universiti Putra Malaysia Teaching Hospital from March 2022 to June 2022. A 2-week walk-in period will be used to assess the efficacy and tolerability of adapalene. The subjects will then randomized into two arms, each receiving different sunscreen, to be used concurrently with adapalene. They will be followed up for another 4 weeks to observe for the improvement of acne severity, post acne hyperpigmentation index, melanin and erythema index and complication rates.
What are the possible benefits and risks of participating?
(a) TO THE SUBJECT
You will be closely followed up according to the study protocol and get to be monitored closely for any potential intolerance to the treatment received. You will also be receiving a good quality sunscreen, which may or may not benefit your facial acne and pigmentation. You will get to have your skin assessed in a more objective manner, which rarely available during the usual clinic consult. During each followup, you will be assigned with a RM30 emolument to cover your travel expenses. Please be informed that tea/ lunch will be provided, depending on your visiting time.
(b) TO THE INVESTIGATOR
This study will allow the health care provider to understand the role of sunprotection and its active ingredients in acne and acne pigmentation management better.
Where is the study run from?
Universiti Putra Malaysia Teaching Hospital
When is the study starting and how long is it expected to run for?
October 2021 to July 2022
Who is funding the study?
This study will be funded by Beiersdorf (Malaysia) Sdn Bhd
Who is the main contact?
Dr Kang Nien How, hkangnien@upm.edu.my
Contact information
Principal Investigator
Faculty of Medicine and Health Sciences
Universiti Putra Malaysia
Serdang
43400
Malaysia
 ORCID ID |
0000-0002-8032-9804 |
|---|---|
| Phone | 03 9769 5601 |
| hkangnien@upm.edu.my |
Study information
| Study design | Randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet. |
| Scientific title | A comprehensive study of the efficacy and safety of Licochalcone A , Glycyrrhetinic acid and L-Carnitine containing sun block in the management of acne and post acne pigmentation among Malaysian patients : A randomized, double blinded, comparator controlled trial |
| Study objectives | Licochalcone A, Glycyrrhetinic acid and L-Carnitine containing sunscreen is effective is reducing acne and post acne hyperpigmentation. |
| Ethics approval(s) | Approved 06/10/2021, Universiti Putra Malaysia Ethic Committee for Research Involving Human Subject (JKEUPM, Universiti Putra Malaysia, 43400 UPM Serdang, Selangor Darul Ehsan, Malaysia; +60 397691605; jkeupm@upm.edu.my), ref: UPM/TNCPI/RMC/JKEUPM/1.4.18.2 |
| Health condition(s) or problem(s) studied | Improve the treatment of acne and acne pigmentation |
| Intervention | Walk in period using adapalene for 2 weeks, followed by randomization into intervention and control arm Intervention: Lichochalcone A containing sunscreen + Adapalene Control arm: Comparator sunscreen + adapalene Follow-up duration for intevention: 4 weeks Total duration of study: 6 weeks Randomization process: chit method - total 56 chits were divided into 2 groups, 23 each. Each chit was written "A" or "B". These chits are then put into a black box, not visible from the outside. Participants were asked to draw from this box. They were randomized according to which chit they had drawn. A was into intervention, while B was into the control arm. Chits drawn will be discarded and will not be replaced. |
| Intervention type | Other |
| Primary outcome measure | 1. Acne severity using CASS at baseline and week 6 2. Post acne pigmentation using PAHPI at baseline and week 6 |
| Secondary outcome measures | At baseline and week 6: 1. Total number of inflammatory and non inflammatory acne 2. Acne severity using GAGS 3. Post acne pigmentation using skin analyser 4. Sebum using sebumeter 5. Skin pH using pH meter probe 6. Treatment related complications using a check list of anticipated complication, and subjects' own report 7. Weight of cleanser, tretinoin and sunblock – determine compliance: subjects were asked to bring back their cleanser, tretinoin and sunblock. The above will be weighted using a weighing machine up to 2 decimal point. 8. Patient satisfaction to treatment using visual analogue scale. Scale range from worse, no change, good, very good. 9. Acne related quality of life using CADI |
| Overall study start date | 06/10/2021 |
| Completion date | 30/07/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 56 |
| Total final enrolment | 50 |
| Key inclusion criteria | 1. Males and females with acne vulgaris aged ≥18 years old 2. Clinically diagnosed by dermatologist as acne vulgaris on the face with 2.1. Inflammatory lesion (papules and pustules) of <25 2.2. Non inflammatory lesions (open or close comedones of <50) 3. Patient must have post acne pigmentation with at least a PAHPI score of 6 |
| Key exclusion criteria | 1. Other forms of acne (acne conglobata, acne excoriate, acne rosacea, acne cosmetica, pomade acne, acne fulminans, acne keloidalis nuchae, acne chloracne, acne mechanica and acne medicamentosa) 2. Nodulocystic acne 3. CASS 4-5 4. On oral antibiotic for the last 1 months 5. On oral isotretinoin for the last 6 months 6. On topical antimicrobial or tretinoin for the last 2 weeks 7. Photosensitivity 8. If patient is currently pregnant or lactating 9. Other comorbidities that require any route of medication commencement (i.e hypertension, diabetes, dyslipidemia, bronchial asthma) 10. If there is any known allergy to the active ingredients in the preparation 11. Patients who have any other facial dermatoses 12. Patients who like outdoor activities and couldn’t comply to sunprotection. |
| Date of first enrolment | 01/03/2022 |
| Date of final enrolment | 30/06/2022 |
Locations
Countries of recruitment
- Malaysia
Study participating centre
Serdang
43400
Malaysia
Sponsor information
Industry
Level 12, Tower 1
PJ33, 3, Jalan Professor Khoo Kay Kim
Seksyen 13
Petaling Jaya
46200
Malaysia
| Phone | +60 3-7940 9668 |
|---|---|
| Wilson.Chew@Beiersdorf.com |
Funders
Funder type
Industry
Private sector organisation / For-profit companies (industry)
- Location
- Germany
Results and Publications
| Intention to publish date | 30/10/2022 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publication in a Q3 ISI indexed journal "Cosmetic" |
| IPD sharing plan | The data-sharing plans for the current study are unknown and will be made available at a later date |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 23/12/2023 | 06/08/2024 | Yes | No |
Editorial Notes
06/08/2024: Publication reference added.
11/10/2022: Trial's existence confirmed by Universiti Putra Malaysia Ethic Committee
