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A clinical trial to study the effects of two topical applications, Adapalene (0.1 percent) and Topical Unani Formulation in patients with Acne Vulgaris .

A RANDOMIZED, PARALLEL GROUP, OPEN LABEL, ACTIVE CONTROLLED CLINICAL STUDY TO COMPARE THE SAFETY AND EFFICACY OF A TOPICAL UNANI FORMULATION WITH ADAPALENE (0.1 percent) IN THE MANAGEMENT OF BUTHUR LABANIYYA (ACNE VULGARIS) - NIL

Status
Active, not recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/03/082481
Enrollment
60
Registered
2025-03-17
Start date
Unknown
Completion date
Unknown
Last updated
2025-04-07

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

Conditions

Health Condition 1: L700- Acne vulgaris

Interventions

Intervention1: Topical Unani Formulation: Dimad containing Kaf-e-dariya, Mom (Wax),Roghan-e-gul will be topically applied once a day on lesion. Control Intervention1: Adapalene (0.1%): Dosage Form :

Sponsors

National Research Institute of Unani Medicine for Skin Disorders
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Clinically diagnosed cases of acne vulgaris. 2.Individuals exhibiting any of the subsequent signs and symptoms of Buthur Labaniyya (Comedones, Papules, Pustules, Nodules, Itching, Erythema). GAGS score less than 30. Clinically stable patients. 3.Participants who are competent to follow up and who will provide assent.

Exclusion criteria

Exclusion criteria: 1.Individuals who are under 15 or older than 35. 2.Patients with GAGS score more than 30. 3.Individuals who suffer from other types of acne, such as eczema, rosacea, acne necrotica, or acne fulminans. 4.Patients undergoing oral contraceptive or androgen medication, or receiving corticosteroid or anticonvulsant therapy . 5.Pregnant or Lactating Women.Significant Pulmonary/ Cardiovascular/ Hepato-Renal dysfunction and other disorders requiring long-term treatment.Known cases of immunocompromised states (HIV/ AIDS etc.) Malignancies. 6.Patient who have used isotretinoin in last six months.

Design outcomes

Primary

MeasureTime frame
Change in GAGS.Timepoint: 0,2 and 4 weeks

Secondary

MeasureTime frame
1.Change in PGA, DLQI Score from baseline 2.Improvement in symptoms from baseline Timepoint: 0,2 and 4 weeks

Countries

India

Contacts

Public ContactDr Ashfaque Alam

National Research Institute of Unani Medicine for Skin Disorders

drashfaque6@gmail.com8103161174

Outcome results

None listed

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