Topical/Cutaneous Moderate to severe melasma of the face
Adult: Available preparation:
Each g of cream contains fluocinolone acetonide 0.1 mg, hydroquinone 40 mg, and tretinoin 0.5 mg
Short-term treatment: Apply thinly once daily at night (at least 30 minutes before bedtime) onto the affected area(s) including approx 1/2 inch of normal appearing skin surrounding each lesion. Continue the therapy until control is achieved. Max treatment duration: 8 weeks.
Special Precautions
Patient receiving hormonal contraceptives may consider changing to non-hormonal contraceptive measures. Not intended for the maintenance treatment of melasma. Use in darker skin types (Fitzpatrick skin types V and VI) has not been evaluated. Pregnancy and lactation.
Adverse Reactions
Significant: Cutaneous hypersensitivity/contact dermatitis, exogenous ochronosis, Kaposi’s sarcoma (prolonged use); systemic effects (e.g. adrenal suppression, manifestations of Cushing’s syndrome, hyperglycaemia, glycosuria); visual disturbances (e.g. blurred vision, cataract, glaucoma, central serous chorioretinopathy). Gastrointestinal disorders: Dry mouth. General disorders and administration site conditions: Application site reactions (e.g. local irritation, inflammation, erythema, burning sensation, desquamation, dryness, xeroderma, pruritus). Nervous system disorders: Paraesthesia, hyperaesthesia. Skin and subcutaneous tissue disorders: Acne, telangiectasia, pigmentary changes, papules, acne-like rash, rosacea, rash, vesicles.
Avoid exposure to sunlight and UV light; use sunscreen or wear protective clothing during the day. Do not use occlusive dressings on the affected area. Avoid contact with mucous membranes, eyes, nose, angles of the mouth, and abraded skin.
Monitoring Parameters
May consider confirming the pregnancy status prior to treatment initiation in women of reproductive potential. Monitor for signs or symptoms of hypothalamic-pituitary-adrenal (HPA) axis suppression.
Overdosage
Symptoms: Excessive marked peeling, redness, and discomfort at the application site. Management: Symptomatic treatment. Apply less frequently or discontinue use altogether.
Drug Interactions
May cause additive photosensitivity when used concomitantly with known photosensitising agents (e.g. glimepiride, chlorpromazine, hydrochlorothiazide).
Food Interaction
May enhance adverse effects with vitamin A-containing foods (e.g. cod liver oil, halibut fish oil).
Action
Description: Mechanism of Action: Fluocinolone acetonide is a topical corticosteroid. It induces phospholipase A2 inhibitory proteins (lipocortins) and sequential inhibition of arachidonic acid release, thus reducing the formation, release, and activity of endogenous chemical mediators of inflammation (e.g. kinins, liposomal enzymes, histamines, prostaglandins).
Hydroquinone suppresses the metabolic processes of melanocytes, particularly the inhibition of the enzymatic oxidation of tyrosine to 3,4-dihydroxyphenylalanine (DOPA), thereby producing reversible depigmentation of the skin.
Tretinoin, a derivative of vitamin A, modifies epithelial growth and differentiation. Pharmacokinetics: Absorption: Minimally absorbed percutaneously. Metabolism: Metabolised in the liver (for the small amount absorbed). Excretion: Via urine and faeces.
Chemical Structure
Fluocinolone acetonide Source: National Center for Biotechnology Information. PubChem Compound Summary for CID 6215, Fluocinolone acetonide. https://pubchem.ncbi.nlm.nih.gov/compound/Fluocinolone-acetonide. Accessed Jan. 25, 2021.
Hydroquinone Source: National Center for Biotechnology Information. PubChem Compound Summary for CID 785, Hydroquinone. https://pubchem.ncbi.nlm.nih.gov/compound/Hydroquinone. Accessed Oct. 24, 2023.
Tretinoin Source: National Center for Biotechnology Information. PubChem Database. Tretinoin, CID=444795, https://pubchem.ncbi.nlm.nih.gov/compound/Tretinoin (accessed on Jan. 23, 2020)
Anon. Fluocinolone (Topical). Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 09/10/2020.Anon. Fluocinolone, Hydroquinone, and Tretinoin. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 09/10/2020.Anon. Hydroquinone. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 09/10/2020.Anon. Tretinoin (Topical). Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 09/10/2020.Buckingham R (ed). Hydroquinone. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 09/10/2020.Fluocinolone; Hydroquinone; Tretinoin. Gold Standard Drug Database in ClinicalKey [online]. Elsevier Inc. https://www.clinicalkey.com/. Accessed 06/11/2020.Tri-Lucent Cream (HOE Pharmaceuticals Sdn. Bhd.). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 09/10/2020.Tri-Luma Cream (Galderma Laboratories, L.P.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 09/10/2020.Tri-Luma Cream (Zuellig Pharma Sdn Bhd). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my/. Accessed 09/10/2020.
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