Efficacy and safety of sun block in the management of acne and post acne pigmentation among Malaysian patients

Not Applicable

Completed

• Conditions: Improve the treatment of acne and acne pigmentation; Skin and Connective Tissue Diseases

• Registration Number: ISRCTN31328643
• Lead Sponsor: Beiersdorf (Malaysia)

Brief Summary

2023 Results article in https://pubmed.ncbi.nlm.nih.gov/38152154/ (added 06/08/2024)

Detailed Description

Not available

Study Timeline

• Study Completion: 2022-07-30
• Study Start: 2022-10-26
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 50

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Acne severity using CASS at baseline and week 6<br>2. Post acne pigmentation using PAHPI at baseline and week 6

Secondary Outcome Measures

Name	Time	Method
At baseline and week 6:<br>1. Total number of inflammatory and non inflammatory acne<br>2. Acne severity using GAGS<br>3. Post acne pigmentation using skin analyser<br>4. Sebum using sebumeter<br>5. Skin pH using pH meter probe<br>6. Treatment related complications using a check list of anticipated complication, and subjects' own report <br>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. <br>8. Patient satisfaction to treatment using visual analogue scale. Scale range from worse, no change, good, very good. <br>9. Acne related quality of life using CADI