更新于：2024-11-01

Galderma India Pvt Ltd.

子公司|

India

子公司|

India

更新于：2024-11-01

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项与 Galderma India Pvt Ltd. 相关的临床试验

CTRI/2024/08/072412 / Not yet recruiting临床4期

A prospective, multi center, open label phase IV clinical study to evaluate the safety and efficacy of Trifarotene or Aklief 50 microgram per gram cream in subjects with acne vulgaris over 12 weeks. - NIL

开始日期2024-08-26

申办/合作机构

Galderma SA (Switzerland)

[+1]

CTRI/2021/06/034069 / Active, not recruiting临床4期

A prospective, multicenter, open label, phase IV study to evaluate safety and efficacy of Adapalene 0.3% - Benzoyl peroxide 2.5% gel in subjects with Moderate to Severe Acne Vulgaris.

开始日期2021-12-24

申办/合作机构

Galderma India Pvt Ltd.

CTRI/2018/01/011403 / Completed临床4期

Evaluation of â??Quality of Lifeâ?? and in-use tolerance in women with facial melasma, after using a triple combination drug (TRI-LUMA Cream)

开始日期2018-02-05

申办/合作机构

Galderma India Pvt Ltd.

100 项与 Galderma India Pvt Ltd. 相关的临床结果

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0 项与 Galderma India Pvt Ltd. 相关的专利（医药）

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项与 Galderma India Pvt Ltd. 相关的文献（医药）

2024-07-31·Cureus

Investigating the Use of 0.3% Adapalene/2.5% Benzoyl Peroxide Gel for the Management of Moderate-to-Severe Acne in Indian Patients: A Phase 4 Study Assessing Safety and Efficacy

Article

作者: Sen, Dyotona ; Batra, Rohit ; Jadhwar, Sameer ; Gaurkar, Sudarshan ; Mukhopadhyay, Partha ; Yogendra, M

Background Acne vulgaris is a chronic inflammatory disease of the pilosebaceous unit associated with an increase in sebum secretion. Topical treatment with adapalene and benzoyl peroxide (BPO) is considered effective when used either as monotherapy or in fixed-dose combinations. However, the combination gel of 0.3% adapalene with 2.5% benzoyl peroxide (A0.3%+BPO2.5%) has not been evaluated in Indian patients with acne. This study aimed to evaluate the safety and efficacy of A0.3%+BPO2.5% gel in Indian patients with moderate-to-severe acne vulgaris. Methodology This was a 12-week prospective, multicenter, open-label, phase IV study conducted at six centers in India. Safety was assessed based on local tolerability (stinging or burning, erythema, dryness, and scaling) and any reported adverse events. Efficacy was evaluated based on reductions in the number of inflammatory and noninflammatory lesions, the Investigator's Global Assessment (IGA) scale, and the Global Assessment of Improvement (GAI) score. The patient-reported outcome was measured using the Subject Satisfaction Questionnaire. Results Of the 135 patients, 132 completed the study between December 24, 2021, and July 18, 2022 (93.9% had moderate acne; 6.1% had severe acne at baseline). The A0.3%+BPO2.5% gel was well tolerated. The reductions in the severity scores of erythema, scaling, and dryness from baseline to week 12 were 38.9%, 47.4%, and 76.5%, respectively. A targeted reduction of ≥50% in the number of inflammatory and noninflammatory lesions was achieved in 115 (87.1%) and 109 (82.6%) patients, respectively. Based on the investigator's responses to the IGA questionnaire at week 12, 28% and 40.9% of patients had clear and almost clear skin, respectively. Using the GAI scale, investigators reported that at 12 weeks from baseline, most patients presented with improvements in symptoms, such as erythema, scaling, and dryness, and none reported any worsening. Treatment satisfaction was rated as 91% by the patients. Conclusions The A0.3%+BPO2.5% gel effectively reduced the inflammatory and noninflammatory lesions and was found to be safe and well tolerated in Indians with moderate‑to‑severe acne vulgaris.

2024-07-30·Cureus

Role of Trifarotene in the Management of Acne in Indian Patients: Insights From an Indian Dermatology Experts' Meeting

Review

作者: Tiwari, Anurag ; Jadhwar, Sameer ; Tahiliani, Sushil T ; Damisetty, Rajetha ; D S, Krupashankar ; Satish, D A ; Aurangabadkar, Sanjeev ; Madnani, Nina ; Das, Anupam ; Sen, Dyotona ; Saraswat, Abir

Acne vulgaris, a prevalent inflammatory skin condition, significantly impacts individuals worldwide, particularly adolescents and adults. Its chronic nature, associated sequelae, and psychosocial impact underscore the substantial burden it poses. Current treatment guidelines primarily address facial acne, with limited guidance on managing truncal acne. Personalized approaches are increasingly recognized as essential for tailoring treatments to individual patient needs. This review integrates insights from an Indian Dermatology Experts' Meeting, featuring perspectives from nine leading dermatologists. Discussions centered on analyzing acne's burden, its effects on quality of life (QoL), unmet needs in management, trifarotene's role in Indian therapy, anticipated challenges, and the importance of ancillary care. The experts highlighted acne's profound impact on patients' QoL and identified gaps in current management guidelines, especially concerning truncal acne. Trifarotene, a fourth-generation topical retinoid approved by the FDA and Drug Controller General of India (DCGI) for facial and truncal acne, demonstrated safety and efficacy across age groups. This synthesis of expert perspectives underscores the need for personalized acne management. Trifarotene emerges as a promising therapeutic option but challenges remain, particularly in optimizing ancillary care to minimize treatment-related adverse effects. Addressing these issues will enhance treatment outcomes and patient satisfaction in acne management, emphasizing the importance of tailored approaches in clinical practice.

2024-06-28·IP Indian Journal of Clinical and Experimental Dermatology

A survey assessing the role of a fixed-dose combination of 0.3% adapalene with 2.5% benzoyl peroxide in acne vulgaris

作者: Agarwal, Megha ; Jadhwar, Sameer ; Walia, Parmjit ; Sen, Dyotona

Acne is a common skin condition affecting adolescents and young adults, characterized by the blockage of sebaceous glands along with bacterial colonization of the follicular duct and inflammation. Collagen and tissue damage secondary to acne inflammation brings about severe skin texture changes, including scarring. Timely treatment initiation is crucial to prevent acne progression to scarring. Topical retinoids, topical oral antimicrobials, or a combination of both are recommended as the first-line therapy for acne. The objective of the present survey was to assess the role of 0.3% adapalene/2.5% benzoyl peroxide (BPO) combination in those with mild-moderate acne. The objective of the present survey was to assess the role of 0.3% adapalene/2.5% BPO combination in those with mild-moderate acne.: A total of 438 healthcare professionals (dermatologists and cosmetologists) participated in the survey, through which their patients’ experiences with the product were recorded. : A significant proportion of the patient population (31%) experienced improvement just after 2 weeks of treatment with the combination. Most patients (84%) also found it easy to include the product in their skincare regime. Most healthcare professionals and patients (>80%) rated the effectiveness and tolerability of the intervention as ‘good’ to ‘excellent’. : The survey confirms the 0.3% adapalene/2.5% BPO combination as an efficacious, easy-to-use topical treatment option for moderate to severe acne with the potential to impact acne scars, in line with findings from other studies examining the effect of this combination.

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100 项与 Galderma India Pvt Ltd. 相关的转化医学

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