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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN31328643
Enrollment
56
Registered
2022-10-26
Start date
2022-03-01
Completion date
Unknown
Last updated
2024-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Improve the treatment of acne and acne pigmentation Skin and Connective Tissue Diseases

Interventions

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 sunscre

Sponsors

Beiersdorf (Malaysia)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
1. Acne severity using CASS at baseline and week 6 2. Post acne pigmentation using PAHPI at baseline and week 6

Secondary

MeasureTime frame
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

Countries

Malaysia

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026