A Clinical trial to study the effects of two drugs , metformin lotion and modified kligman formula cream in patients with melasma , a type of facial pigmentation.

A split face study to compare efficacy and safety of Modified Kligman Formula (Hydroquinone 2% + Tretinoin 0.05% + Flucinolone Acetonide 0.01%) with Topical Metformin 30% in the patients with Melasma - A Prospective Comparative Study in Tertiary Care Hospital - NIL

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/10/075324

Enrollment

Registered

2024-10-15

Start date

Unknown

Completion date

Unknown

Last updated

2024-11-11

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

Conditions

Health Condition 1: L811- Chloasma

Interventions

Intervention1: Topical 30% Metformin: Lotion of Metformin 30% applied topically over dark spots (melasma lesions) on face at night time and regular sunscreen in the morning for period of 08 weeks. T

Eligibility

Inclusion criteria

Inclusion criteria: 1.Patients willing to participate in study and give valid consent for the same. 2.Patients of age group 18-60 years of either gender. 3. Patients whose diagnosis suggests melasma, and on examination have it’s symmetrical distribution on both sides of face.

Exclusion criteria

Exclusion criteria: 1. Pregnant/Lactating Females 2. Active case of acne vulgaris, rosacea 3. Patients who are having skin manifestations of any underlying liver and kidney disease. 4. Immuno-compromised patients 5. H/O previous treatment like laser ablation/peels/derma-brasion 6. Patient allergic to metformin 7. Patient taking Oral contraceptive pills. 8. Patient taking tablet metformin orally.

Design outcomes

Primary

Measure	Time frame
To study the efficacy of two different modalities of treatment in the melasma and to compare them with each other i.e Combination Hydroquinone 2% + Flucinolone Acetonide 0.01% + Tretinoin 0.05% and Topical metformin 30% on the parameters of MASI Score, Dermoscopic Assessment, Patient Assessment and Physician Global AssessmentTimepoint: 04 weeks, 08 weeks	—

Secondary

Measure	Time frame
To study the adverse effects of two different modalities of treatment in the melasma and to compare them with each other.Timepoint: 04 weeks, 08 weeks	—

Countries

India

Contacts

Public ContactManjeet Ramteke

Grant Government Medical College Mumbai

manjeetramteke@gmail.com9970284767

Outcome results

None listed

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